Clinical trial NCT03224585
Conditions: Acute Pericarditis
Keywords: anakinra Kineret pericarditis
Sponsor: Virginia Commonwealth University
Start date: 2018-05-11; Completion date: 2020-02-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to determine the safety and efficacy of anakinra for the treatment of acute pericarditis when initiated within 6 hours of diagnosis and continued for 3 or 7 days.

1. to determine the efficacy of anakinra with respect to chest pain resolution
2. to determine the safety of anakinra with respect to adverse drug events

Detailed description:
Acute pericarditis is a clinical syndrome characterized by a profound inflammation of the membrane tissue that surrounds, supports and protects the heart. Acute pericarditis can be caused by a variety of infectious and non-infectious agents, but it most commonly either follows a viral infection of the upper respiratory tract or has no apparent cause.

Acute pericarditis occurs rather abruptly in previously healthy individuals, generally a child or young adult. Most cases of acute pericarditis resolve within a few days with non-steroidal anti-inflammatory drugs. However, patients experience severe chest pain and are at high risk for life-threatening complications involving the pericardium, such as pericardial tamponade. Acute pericarditis is diagnosed in 1 in 20 (5%) ED visits for chest pain.

Anakinra (Kineret) has been shown to treat and cure refractory and recurrent pericarditis. This study is aimed at determining whether anakinra is also effective as first line treatment in acute pericarditis.

Arms: arm 1: 100 mg subcutaneous injection arm 2: 100 mg NaCl 0.9% subcutaneous injection
Interventions: intervention 1: Anakinra intervention 2: Placebo
Intervention descriptions: intervention 1: Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.

Period 2 (Time 72 hours to 7 days) - anakinra 100 mg subcutaneous injections daily for 4 days intervention 2: Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.

Period 2 (Time 72 hours to 7 days) - placebo 100 mg saline subcutaneous injections daily for 4 days

Protocol documents:
ICF_000.pdf: 
 
 
Title: Treatment of Acute Pericarditis With Anakinra 
 
NCT #: NCT03224585 
 
Document approval date: June 8, 2017 
 
Document Type: Informed Consent Form 
 
 
 


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RESEARCH PARTICIPANT INFORMATION AND CONSENT FORM
TITLE: Treatment of Acute Pericarditis with Anakinra
VCU IRB PROTOCOL NUMBER: HM20008638
INVESTIGATOR: Antonio Abbate MD, PhD; Virginia Commonwealth University
FUNDING SOURCE: Swedish Orphan Biovitrum, LLC
Please ask the study doctor or staff to explain any information in this consent document that is 
not clear to you.  You may review this consent form with family or friends before making your 
decision. In this consent form, “you” always refers to the research participant. 
PURPOSE OF THE STUDY
The purpose of this study is to determine if anakinra (Kineret) can lower the inflammation and 
the pain that are caused by acute pericarditis. This study will enroll 14 patients.
DESCRIPTION OF THE STUDY 
Acute pericarditis is a condition in which the sac around the heart (pericardium) becomes 
irritated and causes chest pain. An injury to the cells in pericardium, usually an infection by a 
virus, leads to inflammation, a process by which white blood cells come from the blood to the 
pericardium to repair the injury.
In acute pericarditis, the inflammation is out of control, and lasts longer than it should, causing 
sharp chest pain. As such, anti-inflammatory drugs are given to reduce the intensity of 
inflammation and alleviate the pain. Although there are no anti-inflammatory drugs specifically 
developed or indicated for the treatment of acute pericarditis, non-steroidal anti-inflammatory 
drugs (NSAIDs), such as aspirin, ibuprofen or diclofenac, are commonly used and are effective in 
reducing inflammation and pain.
NSAIDs may be associated with side effects such as irritation of the stomach (gastritis), injury to 
the kidneys (renal failure) and increased bleeding tendency (alteration of platelet function). 
Moreover, NSAID treatment does not reduce the chances of having acute pericarditis again and 
many patients will have repeat episodes of acute pericarditis.
Colchicine is another anti-inflammatory drug that works in a different way than NSAIDs. 
Colchicine can be used with NSAIDS to help reduce the chances of repeat episodes of acute 
pericarditis. The side effects of colchicine include stomach pain, severe diarrhea and, rarely, 
with severely low numbers of blood cells (bone marrow suppression). There is therefore a need 
to find new treatments for acute pericarditis that are effective, safe, and well tolerated.
This study is designed to determine if Anakinra (Kineret) can be an effective, safe, and well 
tolerated treatment for acute pericarditis. We will measure levels of inflammation and pain in 
patients with acute pericarditis who are having a first or recurrent episode.
Anakinra (Kineret) is a “copy” of an anti-inflammatory protein that the human body naturally 
produces. Since 2001, anakinra has been approved by the United States of America Food & 
Drug Administration (FDA) for the treatment of several inflammatory conditions, such as 
rheumatoid arthritis.
Anakinra has been shown to be effective in patients with severe forms of pericarditis that had 
not responded or had recurred despite treatment with NSAIDs or colchicine. Anakinra does not 
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cause toxicity to the stomach, kidney or platelets like NSAIDs, nor causes abdominal pain or 
diarrhea like colchicine. Anakinra may therefore be a safe and effective treatment for acute 
pericarditis. Anakinra has not been approved by the FDA for the treatment of acute pericarditis, 
and as such its use is considered investigational. 
PROCEDURES
If you decide to be in this study, you will be asked to sign this consent form after you have had 
all your questions answered. The study procedures will begin within 6 hours of your arrival to 
the hospital. Your participation will end with an outpatient visit approximately 30 days later.
After signing this consent form, you will be asked to complete a questionnaire as an 
assessment of your pain. This one-page form will ask you questions about your pain. You will 
then have a blood draw, electrocardiogram (EKG) and heart ultrasound (echocardiogram).
The blood draw will occur with a needlestick into one of your blood vessels. If a catheter (i.e. 
tube) is already available for blood draws, which is common when you are admitted to the 
hospital, then a needlestick will not be necessary and the blood will be drawn using the 
catheter. The total amount of blood drawn will be approximately 1 tablespoon. Performing one 
or more blood draws is usually standard of care when you are in the hospital.
You will also have an electrocardiogram (EKG). Electrodes will be placed on your skin and the 
electricity coming from your heart will be recorded. You will not feel any sensation during this 
test. Performing one or more EKG recordings is usually standard of care when you are being 
treated for acute pericarditis. 
You will also undergo an ultrasound of your heart. During this test (known as an 
echocardiogram), a sensor and a small amount of gel are placed on your chest to create 
pictures of your heart and pericardium. Performing one or more echocardiograms is usually 
standard of care when you are being treated for acute pericarditis.
After you have completed each of these baseline procedures, you will receive treatment with 3 
doses of anakinra over the next 3 days. The first dose will be given as soon as possible and you 
will have a repeat blood draw, EKG, and pain assessment approximately 6 hours later. The next 
2 doses of anakinra will be given every 24 hours. All patients who participate in this research 
will receive at least 3 doses of anakinra.
Each dose of anakinra will be administered with a needle into the fat tissue underneath your 
skin (subcutaneous tissue). If you are in the hospital, then the hospital staff will help you with 
the injection. If you are at home, you or someone else will be taught to give the treatment. The 
dose of anakinra will be 100 mg. This is the usual dose of anakinra when it is used for other 
inflammatory conditions.
All patients who participate in this research will receive at least 3 doses of anakinra. After the 
first 3 doses of anakinra, you will be assigned to continue anakinra or to switch to “placebo” 
treatment, which contains only the watery solution but no active medicine. This assignment will 
occur randomly, like the flip of a coin. Neither you nor the study team will know whether the 
last 4 doses are anakinra or placebo. This is done to determine whether 3 days or 7 days of 
treatment is better.
During this study, anakinra will serve as the main medicine to treat your pain. You will be asked 
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to grade the severity of the pain and we will measure how the anakinra is effective and 
whether additional pain medications are needed. 
During the first 24 hours of anakinra treatment, participation in the study may affect the 
timing and type of other pain medications:

During the first 6 hours of treatment:
o
We will ask you to request additional pain medications only if the pain worsens and 
becomes unbearable (thus allowing to determine the effects of anakinra).
o
Treatment with NSAIDs will be discouraged, favoring other analgesic treatments for 
pain (such as acetaminophen, codeine, tramadol, morphine, etc.) as determined by 
your treating physician. 

Between 6 and 24 hours of treatment:
o
Additional pain medications can be administered for any degree of pain (as 
preferred by the patient).
o
Treatment with NSAIDs will remain discouraged, favoring other analgesic 
treatments for pain, which will be determined by your treating physician. 
o
The amount of pain medication will be recorded.

After 24 hours:
o
There will be no restrictions on the timing or the type of pain medications, but the 
amount of pain medication will be monitored.
You will have 3 follow-up doctor visits after the first dose of anakinra. These will occur after 1 
day, after 7 days and after 30 days. These visits will occur in the VCU Medical Center. While at 
home, you will be asked to record each dose of pain medication that you use while you are 
participating in the study. At each follow-up visit, you will have a blood draw, EKG, 
echocardiogram, and pain assessment. At each visit, you should bring all of your remaining 
study drug supply to the research clinic.
RISKS AND DISCOMFORTS
Possible side effects of Anakinra (Kineret) may include:

Injection site reactions, such as irritation, redness or swelling at the site of administration 
(approximately 1 in every 10 patients); these usually go away on their own (self-limiting)

Headache, diarrhea, and nausea may occur (less than 1 in every 10 patients), usually mild, 
and self-limiting

Neutropenia (low numbers of “neutrophils” which are a type of white blood cell) (very rare, 
less than 1 in every 100 patients)

Anakinra may block your body’s ability to have a fever. This means that you may not have a 
fever if you become sick or ill. If you are feeling sick during the study, please contact your 
study doctor immediately. A small increase in serious infection with Anakinra has been seen 
(less than 1 in every 20 patients) in patients with rheumatoid arthritis on anakinra 
treatment for multiple years in addition to other immunosuppressive disease-modifying 
agents, like methotrexate. The use of anakinra in combination with other potent immune-
modulating drugs is not recommended.

Possible loss of confidentiality

Possibility of becoming upset when asked questions about pericarditis
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
Allergic reaction to Anakinra is possible. Severe allergic reactions can be life threatening. 
Please contact your study doctor or seek immediate medical attention if you experience 
skin rash, swelling, or difficulty breathing as these may be signs of allergic reaction. 

There may be risks associated with this treatment which are unforeseeable.
As the study procedures might injure an unborn child, pregnant women may not participate. 
Women who might become pregnant should use a medically accepted form of birth control 
such as total abstinence, birth control pills, an IUD, diaphragm, progesterone injections or 
implants, or condoms plus a spermicide. Methods of birth control other than total abstinence 
are not 100% effective, and should a women become pregnant there is a risk of injury to an 
unborn child.  For similar reasons, women who are nursing may not participate. For men, the 
study procedures might increase the risks for birth defects of any child conceived during 
treatment and several months after treatment is stopped. Men in this study who have the 
potential of fathering children should be aware of this possibility and should use a medically 
accepted form of birth control.  A pregnancy test will be performed by the primary clinical 
team. The results of this test will be provided to the patient (and the patient’s family if patient 
is under the age of 18) by the primary clinical team. 
Only the study participant can take the study drug. It must be kept out of the reach of children 
and persons who may not be able to read or understand the label.
Additional risks related to procedures:

The potential risks of a blood draw include discomfort, bruising and rarely infection. 

There are no known adverse effects of an EKG. 

During the echocardiogram, you may experience pressure from the probe. 
USE AND DISCLOSURE OF PROTECTED HEALTH INFORMATION
Authority to Request Protected Health Information
The following people and/or groups may request my Protected Health Information:

Principal Investigator and Research Staff

Research Collaborators

Data Safety Monitoring Boards

Others as Required by Law

Study Sponsor

Institutional Review Boards

Government/Health Agencies
Authority to Release Protected Health Information 
The VCU Health System (VCUHS) may release the information identified in this authorization 
from my medical records and provide this information to:  

Health Care Providers at VCUHS

Study Sponsor

Data Coordinators

Data Safety Monitoring Boards

Others as Required by Law

Principal Investigator and Research Staff

Research Collaborators

Institutional Review Boards

Government/Health Agencies
Once your health information has been disclosed to anyone outside of this study, the 
information may no longer be protected under this authorization.
Type of Information that may be Released 
The following types of information may be used for the conduct of this research:
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 Complete health record
Expiration of This Authorization  
 This authorization will expire when the research study is closed, or there is no need to 
review, analyze and consider the data generated by the research project, whichever is later.
Right to Revoke Authorization and Re-disclosure
You may change your mind and revoke (take back) the right to use your protected health 
information at any time.  Even if you revoke this Authorization, the researchers may still use or 
disclose health information they have already collected about you for this study. If you revoke 
this Authorization you may no longer be allowed to participate in the research study.  To revoke 
this Authorization, you must write to the Principal Investigator.
BENEFITS TO YOU AND OTHERS
Based on prior reports in patients with severe forms of acute pericarditis, we expect that 
Anakinra will help to treat inflammation and improve your pain. There is no guarantee however 
that Anakinra will be effective as tested and as such you may not receive any medical benefit 
from being in this study. If Anakinra is found to be helpful to control pain due to acute 
pericarditis, this may be beneficial for other future patients with acute pericarditis. Although 
less likely, it is also possible that Anakinra is not effective in treating acute pericarditis or that 
can even make the condition worse, in which case the study doctor, your doctor or you can 
choose to stop treatment at any time and opt for the standard treatment.
COSTS
You will not be charged for the costs of the study drug or any procedures related to the study. 
The costs of procedures that are performed as part of standard of care will be billed to your 
insurance.
PAYMENT FOR PARTICIPATION 
You will receive compensation for participation in this study to help offset any costs related to 
travel, time off from work, etc. You will receive $100 after the first 24 hours, another $100 after 
the visit on day 7 and another $100 on your last visit on day 30.
ALTERNATIVE TREATMENT
You do not have to participate in this study to be treated for acute pericarditis at this 
institution. If you decide not to enter this study, there are other treatments available. These 
include non-steroidal anti-inflammatory drugs (NSAIDs such as aspirin, ibuprofen) and 
colchicine (also known as Colcrys). Anakinra is not available as a treatment for acute pericarditis 
outside of participation in this study. Ask the study doctor about these options if interested. 
You will be informed of any new findings that may relate to your willingness to continue in the 
research study.
CONFIDENTIALITY 
Potentially identifiable information about you will consist of blood work, EKG results, 
echocardiogram results, and pain assessment answers. Your data will be identified by ID 
numbers, not names, and stored separately from medical records in a locked research area. All 
personal identifying information will be kept in password-protected files and these files will be 
deleted after the study has finished. Access to research data will be limited to study personnel, 
the Food and Drug Administration as required by law and the sponsor (SOBI). SOBI will only 
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have access to de-identified data that cannot be connected back to you. Although results of this 
research may be presented at meetings or in publications, identifiable personal information 
pertaining to participants will not be disclosed.  
It will be noted in your protected electronic medical record at VCU Health System that you are 
in this clinical trial. Information about the study including any medications you may receive will 
be noted in the record. This information is protected just as any of your other medical records 
are protected.  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law.  This Web site will not include information that can identify you.  At most, the 
Website will include a summary of the results.  You can search this Web site at anytime.
VCU is required by federal law to collect your social security number.  Your social security 
number will be kept confidential and will only be used to process payment.
COMPENSATION FOR INJURY or ILLNESS 
If you are injured by, or become ill, from participating in this study, please contact your study 
doctor immediately. Medical treatment is available at the Virginia Commonwealth University 
Health System (VCU Health System). Your study doctor will arrange for short-term emergency 
care at the VCU Health System or for a referral if it is needed.  
Fees for such treatment may be billed to you or to appropriate third party insurance. Your 
health insurance company may or may not pay for treatment of injuries or illness as a result of 
your participation in this study.  To help avoid research-related injury or illness it is very 
important to follow all study directions.
VOLUNTARY PARTICIPATION AND WITHDRAWAL
Your participation in this study is voluntary.  You may decide to not participate in this study.  
Your decision not to take part will involve no penalty or loss of benefits to which you are 
otherwise entitled.  If you do participate, you may freely withdraw from the study at any time 
and opt for the standard treatment for acute pericarditis.  Your decision to with draw will 
involve no penalty or loss of benefits to which you are otherwise entitled. Your participation in 
this study may be stopped at any time by the study doctor without your consent. The reasons 
might include:

the study doctor thinks it necessary for your health or safety;

you have not followed study instructions;

administrative reasons require your withdrawal.
QUESTIONS
If you have any questions, complaints, or concerns about your participation in this research, 
contact:  
Antonio Abbate, MD, PhD
Virginia Commonwealth University
West Hospital, 5th floor, Rm 520
Richmond, VA 23298
(804) 828-0951 (pager 1507)
The researcher/study staff named above is the best person(s) to call for questions about your 
participation in this study. If you have general questions about your rights as a participant in 
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this or any other research, you may contact:
Office of Research, Virginia Commonwealth University
800 East Leigh Street, Suite 3000, P.O. Box 980568
Richmond, VA 23298
Telephone: (804) 827-2157
Contact this number to ask general questions, to obtain information or offer input, and to 
express concerns or complaints about research. You may also call this number if you cannot 
reach the research team or if you wish to talk to someone else. General information about 
participation in research studies can also be found at 
http://www.research.vcu.edu/irb/volunteers.htm.
Do not sign this consent form unless you have had a chance to ask questions and have received 
satisfactory answers to all of your questions. 
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CONSENT
 
I have been provided with an opportunity to read this consent form (composed of 8 pages) 
carefully.  All of the questions that I wish to raise concerning this study have been answered. By 
signing this consent form, I have not waived any of the legal rights or benefits, to which I 
otherwise would be entitled.  My signature indicates that I freely consent to participate in this 
research study.  I will receive a copy of the consent form once I have agreed to participate.
________________________________________________
Participant Name, printed
________________________________________________
________________
Participant Signature 
Date
_______________________________________________ 
(if applicable) Name of Parent or Legal Guardian, printed
_______________________________________________ 
________________
(if applicable) Parent or Legal Guardian Signature
Date
_______________________________________________ 
(OPTIONAL) Name of Parent or Legal Guardian, printed
_______________________________________________ 
________________
(OPTIONAL) Parent or Legal Guardian Signature
Date
_______________________________________________ 
________________
Witness Signature
 
Date
_______________________________________________________
Name of Person Conducting Informed Consent Discussion (Printed)
_______________________________________________ 
________________
Signature of Person Conducting Informed Consent Discussion
Date
_______________________________________________ 
________________
Principal Investigator Signature (if different from above) 
Date
Approved by the VCU IRB on 6/8/2017

SAP_002.pdf: 
 
 
Title: Treatment of Acute Pericarditis With Anakinra 
 
NCT #: NCT03224585 
 
Document approval date: June 8, 2017 
 
Document Type: Statistical Analysis Plan 
 
 


 
 
STATISTICAL ANALYSIS PLAN  
The primary endpoints will compare the change in pain score from baseline to 6 hours and baseline to 24 
hours among all patients using a paired samples Wilcoxon test for nonparametric data.   
 
 
 

Prot_001.pdf: 
 
 
Title: Treatment of Acute Pericarditis With Anakinra 
 
NCT #: NCT03224585 
 
Document approval date: June 8, 2017 
 
Document Type: Protocol 
 
 
 


TREATMENT OF ACUTE PERICARDITIS WITH ANAKINRA: A PILOT STUDY 
Acute pericarditis is a clinical syndrome characterized by an inflammation of the pericardial layers1-2. It can be 
caused by a variety of infectious and non-infectious agents, but it most commonly either follows a viral infection 
of the upper respiratory tract (when the virus is gone) or has no apparent cause, in which case it is referred to 
as idiopathic1-2. Acute pericarditis occurs rather abruptly in previously healthy individual, generally a child or 
young adult. While the prognosis of acute pericarditis is favorable, with most cases resolving within few days, it 
is associated with chest pain and discomfort, often severe and requiring an escalation of therapy, and it is 
occasionally associated with life-threatening complications, such as pericardial tamponade – hypotension and 
shock due to impaired cardiac filling secondary to large pericardial effusion1.  
Acute pericarditis is diagnosed in 1 in 20 (5%) ED visits for chest pain, 1 in 1,000 (0.1%) hospital admissions, 
and in 1 in 10,000 (0.01%) healthy individuals1, reflecting a significant clinical burden worldwide.  
The pathophysiology of acute pericarditis is a stereotypical 
response to an acute injury to the mesothelial cells constituting the 
pericardial layers around the heart. The inflammation is initiated by 
an ‘irritant’ which can be the virus itself or the release of cellular 
debris3-5. The response is however sustained by an amplification of 
the injury through the activation of the Nod-like receptor 3 (NLRP3) 
inflammasome, 
an 
intracellular 
macromolecular 
structure 
responsible for sensing danger or injury and intensifying the 
inflammatory response through the release of mature Interleukin-
1β (IL-1β)3-5. IL-1β is indeed an apical pro-inflammatory cytokine 
that stimulates the synthesis of inflammatory mediators such as 
cyclo-oxygenase-2 (COX-2), prostaglandins and subsequent 
hyperemia, edema, and hyperesthesia characteristic of the acute 
pericarditis syndrome (Figure 1)6. In most instances, by the time the 
subject presents with chest pain, the initial insult can no longer be 
identified, and all that is seen in the inflammatory response.  
Anti-inflammatory therapy has been the mainstay of the treatment 
for acute pericarditis, yet there are no drugs indicated and/or 
approved by the Food & Drug Administration specifically for the treatment of acute pericarditis, and the 
treatments conventionally used are associated with rate limiting side effects or high rate of recurrences1-2. Non-
steroidal anti-inflammatory drugs (NSAIDs) are the most commonly used first line treatment. The anti-
inflammatory activity of NSAIDs is related to the inhibition of COX-2 and reduction in prostaglandins synthesis, 
resulting in local control of pain (Figure 1). NSAIDs (such as indomethacin, diclofenac, ibuprofen) are generally 
effective in controlling symptoms but these drugs significantly increase risk of gastro-intestinal bleeding, 
hypertension and renal failure, and are associated with a significant recurrence rate after discontinuation of 
treatment. Colchicine is used as a second line drug, and is also highly effective by inhibiting tubulin aggregation 
and NLRP3 inflammasome formation. Colchicine however is associated with a 15-20% discontinuation due to 
diarrhea and other gastrointestinal discomforts7, and, although rarely, also with bone marrow suppression (Table 
1). 
Glucocorticoids 
(such 
as 
prednisone) are rarely used in 
acute pericarditis because although 
very effective in controlling acute 
pericarditis by inhibiting NF-kB 
signaling, these drugs increase risk 
of 
gastro-intestinal 
bleeding, 
hypertension, 
and 
are 
also 
associated with a higher recurrence 
rate. In some rare cases, acute 
pericarditis is secondary to another 
disease 
such 
as 
bacterial 
pneumonia, cancer invading the 
pericardium, tuberculosis, connective tissue diseases – in such cases treatment is aimed at the underlying 
disease. While anti-inflammatory drugs relieve pain in all types of pericarditis, elimination of the offending agent 
is essential for healing. 
Injury&
Pro-IL-1β&
NLRP3&inﬂammasome&
IL-1β&
COX-2&
Prostaglandins&
NSAIDs&
(ibuprofen)&
Colchicine&
Anakinra&
gure 1. Pathophysiology of acute pericarditis: 
an injury due to an infectious or non-infectious 
pathogen triggers the formation of the NLRP3 
inflammasome initiating a local and systemic 
ammatory response.  
Treatment 
Advantage(s) 
Disadvantage(s) 
Non-steroidal anti-
inflammatory drugs 
(NSAIDs)[i.e. ibuprofen] 
Highly efficacious in relieving pain 
Increased blood pressure, sodium/
water retention, risk of bleeding 
Colchicine 
Greater response rate when added to 
NSAIDs, prevents recurrences when 
added to NSAIDs 
Gastrointestinal intolerance (15-25%); 
bone marrow suppression (rare) 
Glucocorticoids  
[i.e. prednisone] 
Preferred in cases of connective tissue 
diseases 
Impaired glucose control, increased 
blood pressure, sodium/water 
t
ti
i k f
ti
l
di


 
 
Pil ot st u dy of A n aki nr a  f or ac ut e p eric ar ditis  
V ersi o n 2  
T h er e i s a cl e ar n e e d t o d e v el o p n o v el t h er a pi e s f or a c ut e p eri c ar diti s . 
 
I N N O V A TI O N: 
A s r e pr e s e nt e d i n Fi g ur e 1, N L R P 3  a n d I L- 1b  o c c u p y  a c e ntr al r ol e of i n t h e p at h o g e n e si s of a c ut e p eri c ar diti s: 
a cti v ati o n  of t h e N L R P 3 i nfl a m m a s o m e  l e a d s t o r el e a s e of m at ur e I L- 1b , s y nt h e si s of C O X - 2 a n d  pr o st a gl a n di n s 
a n d s u b s e q u e nt h y p er e mi a a n d p ai n.  S u bj e ct s wit h  s p e cifi c  m ut ati o n s i n t h e Nlr p 3  ( al s o k n o w n a s cr y o p yri n) , 
r e n d eri n g it c o n stit uti v el y a cti v e, e x p eri e n c e s p o nt a n e o u s b o ut s of s y st e mi c i nfl a m m ati o n – cr y o p yri n -a s s o ci at e d 
p eri o di c s y n dr o m e s [ C A P S] 8- 9 - w hi c h ar e e x q ui sit el y r e s p o n si v e t o I L - 1b  bl o c k er s. T h e cli ni c al m a nif e st ati o n s of 
C A P S  v ar y  fr o m  mil d  t o  s e v er e  s y st e mi c  i nfl a m m ati o n,  wit h  a c ut e  p eri c ar diti s b ei n g  o n e  of  t h e  m or e s e v er e 
cli ni c al pr e s e nt ati o n s 1 0 -1 1 . T h e s e r ar e c a s e s of g e n eti c all y m ut at e d Nlr p 3  hi g hli g ht t h e i m p ort a n c e of N L R P 3 i n 
a c ut e  p eri c ar diti s .  A n ot h er  r el ati v el y u n c o m m o n  s y n dr o m e  wit h  f a mili ar  tr a n s mi s si o n  i s r e c urr e nt  i di o p at hi c 
p eri c ar diti s  – a s y n dr o m e of i s ol at e d r e c urr e nt a c ut e p eri c ar diti s o n a n a ut o -i nfl a m m at or y b a si s, a n d alt h o u g h 
t h e g e n e( s) i n v ol v e d ar e u n k n o w n, idi o p at hi c p eri c ar diti s i s al s o r e s p o n si v e t o I L - 1b  bl o c k er s 1 2 . M o st c a s e s of 
p eri c ar diti s ar e h o w e v er  a c q uir e d a n d , g e n er all y, r el at e d t o re c e nt  vir al i nf e cti o n s. Eit h er t h e tr a n si e nt i nf e cti o n 
of  t h e  p eri c ar di al c ell s  b y  t h e  vir u s( e s) or  t h e  i nj ur y  r el at e d  t o  t h e  i nf e cti o n l e a d s  t o  a cti v ati o n  of  t h e  N L R P 3 
i nfl a m m a s o m e  a n d  t h e  N F-k B  a n d  C O X 2 -d e p e n d e nt  i nfl a m m ati o n ,  w hi c h  l e a d s  t o  a  f ull bl o w n  a c ut e 
i nfl a m m at or y r e s p o n s e t h at i s at t h at p oi nt ‘ st eril e’ – fr e e of vir u s( s). T h e cli ni c al s y n dr o m e of p ai n a n d di s c o mf ort 
i s r el at e d t o t h e st eril e i nfl a m m at or y r e s p o n s e . Th e  b e n efi ci al  eff e ct s  of N S AI D s ar e m e di at e d t hr o u g h  i n hi biti o n 
of C O X - 2 a n d r e d u cti o n i n pr o st a gl a n di n pr o d u cti o n 1- 2 . M or e r e c e ntl y c ol c hi ci n e h a s b e e n s h o w n t o b e eff e cti v e 
i n  a c ut e  p eri c ar diti s1 3 .  T h e  r e n e w e d  i nt er e st  i n  c ol c hi ci n e  a s  a nti-i nfl a m m at or y  t h er a p y  i n  a c ut e  i nfl a m m at or y 
di s e a s e  d eri v e s  fr o m it s u s e  a s  a  tr e at m e nt  o f g o ut y  art hriti s .  T hi s h a s  l e d  t o  a  b ett er  u n d er st a n di n g  of t h e 
m e c h a ni s m of a cti o n
1 4 -1 5 . I n vitr o st u di e s n o w li n k it t o t h e N L R P 3 i nfl a m m a s o m e, c ol c hi ci n e i n hi bit s  mi cr ot u b ul e 
f or m ati o n  a n d i nt erf eri n g wit h  t h e  f or m ati o n  of  t h e  m a cr o m ol e c ul ar  str u ct ur e c o m p o s e d  of A S C  ( a p o pt o si s -
a s s o ci at e d s p e c k -li k e pr ot ei n c o nt ai ni n g a c a s p a s e r e cr uiti n g d o m ai n), N L R P 3, pr o -c a p a s e -1 a n d  pr o -I L- 1b , a n d 
h e n c e pr e v e nti n g  a cti v ati o n of t h e N L R P 3 i nfl a m m a s o m e a n d t h e r el e a s e of a cti v e I L - 1b 1 4 -1 5 . W hil e eff e cti v e i n 
m a n y c a s e s , c ol c hi ci n e i s li mit e d b y d o s e-d e p e n d e nt si d e eff e ct s, m ai nl y g a str oi nt e sti n al 7 . I L- 1b  bl o c k er s  ar e  
hi g hl y  eff e cti v e  i n  tr e ati n g  a c ut e  a n d  c hr o ni c  p er i c ar diti s,  i n cl u di n g  t h o s e  s e v er e  c a s e s  t h at  ar e  r efr a ct or y  t o 
N S AI D s  a n d  t o  c ol c hi ci n e 2 , 1 6-2 5 .  T h er e  ar e  s e v er al  dr u g s  a p pr o v e d  b y  t h e  F D A  a s I L- 1b  bl o c k er s i n cl u di n g 
a n a ki nr a  ( Ki n er et ® ), c a n a ki n u m a b  (Il ari s ® ),  a n d  ril o n a c e pt  ( Ar c al y st ®)  b ut n o n e  ar e  a p pr o v e d f or  a c ut e 
p eri c ar diti s 2 6 -2 7 . 
 
 
D e v el o pi n g  a  a n I L-1  bl o c k er  a s  pr ef err e d  tr e at m e nt  f or a c ut e  p eri c ar diti s  wit h o ut  t h e  si d e  eff e ct s  of  t h e 
c urr e ntl y a v ail a bl e tr e at m e nt s , w o ul d b e of gr e at cli ni c al, a n d c o m m er ci al, i m p a ct .  
 
 
I n  c o n cl u si o n,  th e  c urr e nt  tr e at m e nt  f or  a c ut e  p eri c ar diti s  i s  b a s e d  o n N S AI D s  a n d/ or  c ol c hi ci n e.  W hil e  it  i s 
c o n si d er e d st a n d ar d of c ar e, t hi s str at e g y i s n ot b a s e d o n l ar g e cli ni c al tri al s, a n d f ail ur e of t hi s str at e g y i s k n o w n 
t o o c c ur i n t h e f oll o wi n g t er m s: 1) F ail ur e t o a c hi e v e r e s ol uti o n of s y m pt o m s ; 2) o c c urr e n c e of si d e -eff e ct s li miti n g 
u s e ; 3) e arl y r e c urr e n c e of s y m pt o m s aft er di s c o nti n u ati o n of tr e at m e nt . A n a ki nr a ( ki n er et) h a s b e e n s h o w n t o 
tr e at a n d c ur e r efr a ct or y a n d r e c urr e nt p eri c ar diti s. T hi s st u d y i s ai m e d at d et er mi ni n g w h et h er a n a ki nr a i s al s o 
eff e cti v e a s fir st li n e tr e at m e nt i n a c ut e p eri c ar diti s.  
 
A n a ki nr a i s li k el y t o h a v e a m or e f a v or a bl e ri s k pr ofil e a n d b e m or e eff e cti v e t h a n st a n d ar d of c ar e f or a c ut e 
p eri c ar diti s.  T h e  ri s k  of  a n a ki nr a  u s e  ar e  li mit e d  t o  i nj e cti o n  sit e  r e a cti o n  ( a p pr o xi m at el y  1 0 %  if  tr e at m e nt  i s 
c o nti n u e d f or 2 w e e k s or m or e, l e s s if tr e at m e nt i s gi v e n f or l e s s t h a n 1 w e e k), a r e d u cti o n of s y m pt o m s a n d 
si g n s  of s y st e mi c i nf e cti o n w hi c h m a y l e a d t o a m or e wi d e s pr e a d i nf e cti o n at ti m e of di a g n o si s (t hi s ri s k i s l o w, 
< 5 % p er y e ar wit h c o nti n u o u s tr e at m e nt, a n d i s r e d u c e d b y cli ni c al a w ar e n e s s a n d m o nit ori n g f or c h a n g e s i n 
cli ni c al st at u s).  T h e p ot e nti al b e n efit i s f or a r a pi d a n d s u st ai n e d r e s ol uti o n of a c ut e p eri c ar diti s wit h o ut eff e ct s 
o n r e n al f u n cti o n (i. e. n o n -st er o i d al a nti-i nfl a m m at or y dr u g s), g a str oi nt e sti n al si d e eff e ct s (i. e. c ol c hi ci n e) a n d 
i n cr e a s e d ri s k of bl e e di n g (i. e. n o n-st er oi d al a nti -i nfl a m m at or y dr u g s). 
 
S P E CI FI C AI M S :  
 
 
T o d et er mi n e t h e effi c a c y a n d t ol er a bilit y  pr ofil e  of a n a ki nr a i n a c ut e p eri c ar diti s  
 
•  
St e p  I – A s s e s s m e nt of a c ut e p ai n r eli ef  wit h a n a ki nr a at  6 h o ur s  
  
 
( a d diti o n al tr e at m e nt s all o w e d o nl y a s r e s c u e str at e g y [ > 9 p ai n], N S AI D s di s c o ur a g e d) 
 
•  
St e p  II – A s s e s s m e nt of s u b a c ut e p ai n r eli ef  wit h a n a ki nr a at 2 4 -h o ur  
  
 
 ( a d diti o n al tr e at m e nt s all o w e d, N S AI D s di s c o ur a g e d)  
 


 
 
Pil ot st u dy of A n aki nr a  f or ac ut e p eric ar ditis  
V ersi o n 2  
•  
St e p  III – C o m p ari s o n of 3- d a y v s 7 -d a y  a n a ki nr a tr e at m e nt   wit h a s s e s s m e nt at 7 a n d 3 0 d a y s  
 
   
R a n d o mi z e d d o u bl e d -bli n d e d a s si g n m e nt  ( a d diti o n al tr e at m e nt s all o w e d)  
 
M il e st o n e s f or St e p  I [O p e n l a b el a n a ki nr a ]: 
  
•  
R eli ef of c h e st p ai n wit hi n 6  h o ur s of tr e at m e nt  
o  C o m pr e h e n si v e p ai n a s s e s s m e nt s c al e a n d Vi s u al A n al o g P ai n ( 0 -1 0) s c al e    
•  
Eff e ct s o n E C G ( S T el e v ati o n s c or e)  
•  
N e e d f or r e s c u e p ai n tr e at m e nt  ( o pi oi d s) f or s e v er e i ntr a ct a bl e p ai n 
•  
I nt er v al c h a n g e i n I L-6 l e v el s fr o m b a s eli n e t o 6 h o ur s  
•  
Si d e eff e ct s pr ofil e  
 
M il e st o n e s f or St e p  II [O p e n l a b el a n a ki nr a ]:  
 
•  
R eli ef of c h e st p ai n at 2 4 h o ur s wit h Vi s u al A n al o g P ai n ( 0 -1 0 ) s c al e  
•  
Eff e ct s o n E C G ( S T el e v ati o n s c or e)  
•  
U s e of a d diti o n al a n al g e si c or N S AI D s   
•  
Si d e eff e ct s  pr ofil e  
•  
I nt er v al c h a n g e i n I L-6 l e v el s fr o m b a s eli n e at 2 4 h o ur s  
 
M il e st o n e s f or St e p III [ D ur ati o n of A n a ki nr a tr e at m e nt]:  
 
•  
R eli ef a n d/ or r e c urr e n c e of c h e st p ai n o n d a y  7 a n d 3 0   
o  C o m pr e h e n si v e p ai n a s s e s s m e nt s c al e a n d Vi s u al A n al o g P ai n ( 0 -1 0 ) s c al e  
•  
C h a n g e s i n p eri c ar di al eff u si o n at e c h o c ar di o gr a p h y o n d a y 7 a n d 3 0 v s d a y 1  
•  
Si d e eff e ct s pr ofil e o n d a y 7 a n d 3 0  
•  
R e c urr e n c e r at e l e a di n g t o ur g e nt offi c e vi sit, e m er g e n c y d e p art m e nt vi sit, h o s pit ali z ati o n, or ot h er  
•  
C o m pr e h e n si v e m et a b oli c pr ofil e a n d c o m pl et e c ell c o u nt wit h diff er e nti al o n d a y 7 a n d 3 0  
•  
I nt er v al c h a n g e i n C R P a n dI L-6 l e v el s fr o m b a s eli n e t o d a y 7 a n d 3 0  
 
I n cl u si o n crit eri a:  
 
•  
A g e ≥1 2 y e ar s i n pr e s e n c e of a p ar e nt a bl e t o pr o vi d e c o n s e nt or a g e > 1 8 y e ar s  
•  
Fir st or r e c urr e nt e pi s o d e of a c ut e p eri c ar diti s, d efi n e d a s t h e pr e s e n c e of at l e a st 2 of t h e f oll o wi n g:  
o  C h e st p ai n ( s u g g e sti v e of p eri c ar diti s a n d n ot e x pl ai n e d b y ot h er c o n diti o n ) 
o  P eri c ar di al fri cti o n r u b  o n p h y si c al e x a m  
o  S T -s e g m e nt el e v ati o n a n d/ or P R d e pr e s si o n o n E C G  
o  N e w or w or s e ni n g p eri c ar di al eff u si o n  
•  
P ai n of m o d er at e -t o-s e v er e i nt e n sit y ( p ai n s c or e ≥6 o n a s c al e of 0 -1 0 w h er e 0 i s n o p ai n at all a n d 1 0 i s t h e 
w or st p ai n e v er e x p eri e n c e d) at ti m e o n e nr oll m e nt  
•  
A bilit y t o pr o vi d e w ritt e n i nf or m e d c o n s e nt if 1 8 y e ar s or ol d er or t o pr o vi d e a s s e nt i n pr e s e n c e of p ar e nt al 
c o n s e nt if 1 2 -1 7 y e ar s of a g e  
 
E x cl u si o n crit er ia:   
 
•   
Peri c ar diti s  d u e t o b a ct eri al or f u n g al i nf e cti o n   
•  
P eri c ar diti s d u e t o m ali g n a n c y  
•  
P eri c ar diti s aft er c ar di a c s ur g er y  
•  
T a m p o n a d e or n e e d f or p eri c ar di o c e nt e si s f or di a g n o sti c/t h er a p e uti c p ur p o s e s  
•  
Pr e g n a n c y or br e a stf e e di n g  
•  
H y p er s e n siti vit y t o a n a ki nr a, l at e x or  pr o d u ct s d eri v e d fr o m  E s c h eri c hi a c oli  
•  
C hr o ni c p ai n s y n dr o m e s or c hr o ni c u s e of a n al g e si c dr u g s  
 
M o nit ori n g f or u s e of p ai n m e di c ati o n s  
 
T h e u s e of p ai n m e di c ati o n s will b e cl o s el y m o nit or e d d uri n g t h e st u d y.  
•  
D uri n g t h e fir st 6 h o ur s ( St e p I)- t h e u s e of a d diti o n al p ai n m e di c ati o n s will b e di s c o ur a g e d u nl e s s c o n si d er e d 
a n e c e s s ar y r e s c u e str at e g y f or p ai n e x c e e di n g 9 i n 0- 1 0 p ai n s c al e.  
•  
D uri n g t h e ti m e b et w e e n 6 -2 4 h o ur s ( St e p II)- t h e u s e of a d diti o n al p ai n m e di c ati o n will b e all o w e d, b ut t h e 


 
 
Pil ot st u dy of A n aki nr a  f or ac ut e p eric ar ditis  
V ersi o n 2  
u s e  of  n o n -st er oi d al  a nti -i nfl a m m at or y  dr u g s  will  b e  di s c o ur a g e d.  A d diti o n al  p ai n  m e di c ati o n s  (i. e. 
a c et a mi n o p h e n, tr a m a d ol, o x y c o d o n e, m or p hi n e, or ot h er) will b e c o n si d er e d.  
•  
B et w e e n  d a y  2  a n d  d a y  3 0  ( St e p  III),  t h er e  will  b e  n o  r e stri cti o n  o n  t h e  u s e  of  p ai n  m e di c ati o n s,  b ut  t h e 
s u bj e ct s will b e a s k e d t o r e c or d t h e u s e of all p ai n m e di c ati o n s o n a d e di c at e d di ar y.  
 
S a m pl e si z e  f or St e p s I a n d II : 
 
V i s u al An al o g u e S c al e S c or e  
St a n d ar d 
d e vi ati o n  
A b s ol ut e c h a n g e 
at 6  a n d 2 4  h o ur s  
S a m pl e Si z e  
( P o w er = 8 0 %) 
S a m pl e Si z e  
(P o w er = 9 0 % ) 
8 
3 
-3  
1 0  
1 3  
-4  
7  
8  
2 
-2  
8  
1 1  
-3  
4  
5  
 
Pr o p o s e d s a m pl e si z e : 
 
•  
1 4 s u bj e ct s  
 
R E F E R E N C E S  
1.  A dl er Y, C h arr o n P, I m a zi o M, et al. 2 0 1 5 E S C G ui d eli n e s f or t h e di a g n o si s a n d m a n a g e m e nt of p eri c ar di al di s e a s e s: 
T h e  T a s k  F or c e  f or  t h e  Di a g n o si s  a n d  M a n a g e m e nt  of  P eri c ar di al  Di s e a s e s  of  t h e  E ur o p e a n  S o ci et y  of  C ar di ol o g y 
(E S C) E ur H e art J. 2 0 1 5; 3 6: 2 9 2 1 -2 9 6 4.  
2.  I m a zi o M, G ait a F, L e Wi nt er M. E v al u ati o n a n d Tr e at m e nt of P eri c ar diti s: A S y st e m ati c R e vi e w. J A M A 2 0 1 5; 3 1 4: 1 4 9 8-
1 5 0 6.  
3.  M at u si a k M, V a n O p d e n b o s c h N, L a m k a nfi M. C A R D - a n d p yri n -o nl y pr ot ei n s r e g ul ati n g i nfl a m m a s o m e a cti v ati o n a n d 
i m m u nit y. I m m u n ol R e v. 2 0 1 5; 2 6 5: 2 1 7-2 3 0.  
4.  L at z E, Xi a o T S, St ut z A. A cti v ati o n a n d r e g ul ati o n of t h e i nfl a m m a s o m e s. N at R e v I m m u n ol. 2 0 1 3; 1 3: 3 9 7 -4 1 1.  
5.  T ol d o S, M e z z ar o m a E, M a ur o A G, S all o u m F, V a n T a s s ell B W, A b b at e A. T h e i nfl a m m a s o m e i n m y o c ar di al i nj ur y a n d 
c ar di a c r e m o d eli n g. A nti o xi d R e d o x Si g n al 2 0 1 5; 2 2: 1 1 4 6 -6 1.  
6.  Di n ar ell o C A. I nt erl e u ki n -1 i n t h e p at h o g e n e si s a n d tr e at m e nt of i nfl a m m at or y di s e a s e s. Bl o o d 2 0 1 1; 1 1 7: 3 7 2 0 -3 7 3 2.  
7.  E hr e nf el d M, L e v y M, S h ar o n P, et al . G a str oi nt e sti n al eff e ct s of l o n g-t er m c ol c hi ci n e t h er a p y i n p ati e nt s wit h r e c urr e nt 
p ol y s er o siti s (f a mili al m e dit err a n e a n f e v er). Di g Di s S ci. 1 9 8 2; 2 7: 7 2 3 -7.  
8.  H off m a n H M. H er e dit ar y i m m u n ol o gi c di s or d er s c a u s e d b y p yri n a n d cr y o p yri n. C urr Al l er g y A st h m a R e p. 2 0 0 7; 7: 3 2 3. 
 9.  Br o d eri c k L, D e N ar d o D, Fr a n kli n B S, et al  T h e i nfl a m m a s o m e s a n d a ut oi nfl a m m at or y s y n dr o m e s. A n n u R e v P at h ol. 
2 0 1 5; 1 0: 3 9 5 -4 2 4.  
1 0.  K u e m m erl e -D e s c h n er  J B,  T yrr ell  P N,  K o ett er  I,  et  al.  Effi c a c y  a n d  s af et y  of  a n a ki nr a  t h er a p y  i n  p e di atri c  a n d  a d ult 
p ati e nt s wit h t h e a ut oi nfl a m m at or y M u c kl e -W ell s s y n dr o m e Art hriti s R h e u m.  2 0 1 1; 6 3: 8 4 0- 9.  
1 1.  I n s al a c o  A,  Pr e n ci p e  G,  B u o n u o m o  P S,  et  al.  A  n o v el  m ut ati o n  i n  t h e  CI A S 1/ N L R P 3  g e n e  a s s o ci at e d  wit h  a n 
u n e x p e ct e d p h e n ot y p e of cr y o p yri n -a s s o ci at e d p eri o di c s y n dr o m e s Cli n E x p R h e u m at ol. 2 0 1 4 J a n -F e b; 3 2( 1): 1 2 3 -5.  
1 2.  C a nt ari ni L, I m a zi o M, Bri zi  M G, et al. R ol e of a ut oi m m u nit y a n d a ut oi nfl a m m ati o n i n t h e p at h o g e n e si s of i di o p at hi c 
r e c urr e nt p eri c ar diti s. Cli n R e v All er g y I m m u n ol. 2 0 1 3; 4 4: 6-1 3.  
1 3.  I m a zi o M. C ol c hi ci n e f or p eri c ar diti s. Tr e n d s C ar di o v a s c M e d. 2 0 1 5; 2 5: 1 2 9-1 3 6  
1 4.  T o n g D C, Wil s o n A M, L a yl a n d J. C ol c hi ci n e i n c ar di o v a s c ul ar di s e a s e: a n a n ci e nt dr u g wit h m o d er n tri c k s. H e art. 2 0 1 6 
M ar 1 8 – o nli n e fir st . 
1 5.  L e u n g Y Y, Y a o H ui L L, Kr a u s V B. C ol c hi ci n e --U p d at e o n m e c h a ni s m s of a cti o n a n d t h er a p e uti c u s e s. S e mi n Art hriti s 
R h e u m. 2 0 1 5; 4 5: 3 4 1 -3 5 0.  
1 6.  S c h at z  A,  Tr a n kl e  C,  Y a s s e n  A, et  al .  R e s ol uti o n  of  p eri c ar di al  c o n stri cti o n  wit h  A n a ki nr a  i n  a  p ati e nt  wit h  eff u si v e-
c o n stri cti v e p eri c ar diti s s e c o n d ar y t o r h e u m at oi d art hriti s. I nt J C ar di ol 2 0 1 6; 2 2 3: 2 1 5  
1 7. Pi c c o P, Bri s c a G, Tr a v er s o F, et al . S u c c e s sf ul tr e at m e nt of i di o p at hi c r e c urr e nt p eri c ar diti s i n c hil dr e n wit h I nt erl e u ki n-
1 b  r e c e pt or a nt a g o ni st ( a n a ki nr a): a n u nr e c o g ni z e d a ut oi nfl a m m at or y di s e a s e. Art hriti s & R h e u m ati s m. 2 0 0 9; 6 0: 2 6 4 -
2 6 8.  
1 8. V a s sil o p o ul o s D, L a z ar o s G, T si o uf i s C, et al . S u c c e s sf ul tr e at m e nt of a d ult p ati e nt s wit h i di o p at hi c r e c urr e nt p eri c ar diti s 
wit h I nt erl e u ki n -1 r e c e pt or a nt a g o ni st ( a n a ki nr a). I nt J C ar di ol. 2 0 1 2; 1 6 0: 6 6 -7 7.  
1 9. S c ar d a p a n e A, Br u c at o A, C hi ar elli F, Br e d a L. Effi c a c y of a n I nt erl e u ki n - 1b  r ec e pt or a nt a g o ni st ( a n a ki nr a) i n i di o p at hi c 
r e c urr e nt p eri c ar diti s. P e di atr C ar di ol. 2 0 1 3; 3 4: 1 9 8 9-1 9 9 1.  
2 0. L a z ar o s G, V a sil ei o u P, K o ut si a n a s C, A nt o n at o u K, St ef a n a di s C, P e ct a si d e s D, V a s sil o p o ul o s D. A n a ki nr a f or t h e 
m a n a g e m e nt  of  r e si st a nt  i di o p at hi c  r e c urr e nt  p eri c ar diti s.  I niti al  e x p eri e n c e  i n  1 0  a d ult  c a s e s.  A n n  R h e u m  Di s. 
2 0 1 4; 7 3: 2 2 1 5 -2 2 1 7.  


 
 
Pil ot st u dy of A n aki nr a  f or ac ut e p eric ar ditis  
V ersi o n 2  
2 1.  Fi n etti  M,  I n s al a c o  A,  C a nt ari ni  L,  et  al .  L o n g-t er m  effi c a c y  of  I nt erl e u ki n-1  r e c e pt or  a nt a g o ni st  ( a n a k i nr a)  i n 
c orti c o st er oi d -d e p e n d e nt a n d c ol c hi ci n e -r e sist a nt r e c urr e nt p eri c ar diti s. J P e di atr. 2 0 1 4; 1 6 4: 1 4 2 5 -1 4 3 1.  
2 2.  J ai n  S,  T h o n g pr a y o o n  C,  E s pi n o s a  R E,  et  al .  Eff e cti v e n e s s  a n d  s af et y  of  a n a ki nr a  f or  m a n a g e m e nt  of  r efr a ct or y 
p eri c ar diti s. A m J C ar di ol. 2 0 1 5; 1 1 6: 1 2 7 7 -1 2 7 9.  
2 3. Br u c at o A, I m a zi o M, M a e str o n i S, et al . A n a ki nr a i n p ati e nt s wit h c orti c o-d e p e n d e nt i di o p at hi c r e c urr e nt p eri c ar diti s: a 
r a n d o mi z e d d o u bl e-bli n d pl a c e b o -c o ntr oll e d wit h dr a w al tri al [ a b str a ct]. Art hriti s R h e u m at ol. 2 0 1 5; 6 7( s u p pl 1 0). A b str a ct 
n u m b er 3 0 7 7.  
2 4.  D’ Eli a  E,  Br u c at o  A,  P e dr otti  P,  et  al .  S u c c e s sf ul  tr e at m e nt  of  s u b a c ut e  c o n stri cti v e  p eri c ar diti s  wit h  i nt erl e u ki n- 1b  
r e c e pt or a nt a g o ni st. Cli n E x p R h e u m at ol. 2 0 1 5; 3 3: 2 9 4 -5.  
2 5. L a z ar o s G, V a sil ei o u P, D a ni a s P, et al . Eff u si v e-c o n stri cti v e p eri c ar diti s s u c c e s sf ull y tr e at e d wit h  a n a ki nr a. Cli n E x p 
R h e u m at ol. 2 0 1 5; 3 3: 9 4 5.  
2 6 . M a ur o A G, T h ur b er C J, A b b at e A. C ol c hi ci n e i n A c ut e M y o c ar di al I nf ar cti o n: “ T e a c hi n g N e w Tri c k s t o a n Ol d D o g”. 
Tr a n sl ati o n al M e di ci n e 2 0 1 5 ; Tr a n sl M e d 5: e 1 3 3.  
2 7 . V a n T a s s ell B W, T ol d o S, M e z z ar o m a E, A b b at e A. T ar g eti n g i nt erl e u ki n -1 i n h e art di s e a s e.  Cir c ul ati o n. 2 0 1 3; 1 2 8: 1 9 1 0 -
1 9 2 3.  
 
 


 
 
Pil ot st u dy of A n aki nr a  f or ac ut e p eric ar ditis  
V ersi o n 2  
 
 
S u bj e ct I d e ntifi er: 
D at e:  
 
Pl e a s e r at e t h e i nt e n sit y of y o ur p ai n b el o w: 
M ar k t h e ar e a s w h er e y o u c urr e ntl y f e el p ai n. 
 
 
Fr e q u e n c y of p ai n: 
_ _ _ C o n st a nt 
_ _ _ Fr e q u e nt 
_ _ _ I nfr e q u e nt 
_ _ _ U n k n o w n 
 
 
D e s cri pti o n of p ai n: 
_ _ _ A c hi n g 
_ _ _ B ur ni n g 
_ _ _ Cr a m pi n g 
_ _ _ Cr u s hi n g 
_ _ _ D ull  
_ _ _ N u m b n e s s  
_ _ _ Pi n s a n d n e e dl e s 
_ _ _ S h ar p 
_ _ _ S h o oti n g 
_ _ _ T hr o b bi n g 
 
 
C h a n g e i n p att er n of p ai n: 
H a s t h e p ai n c h a n g e d i n i nt e n sit y i n t h e l a st 2 4 h o ur s ? 
_ _ _ Y e s (if y e s, d e s cri b e b el o w) 
 
 
_ _ _ N o  
_ _ _ U n k n o w n 
C a u s e s of p ai n or w or s e ni n g of p ai n: 
_ _ _ M o v e m e nt  
_ _ _ C o u g hi n g  
_ _ _ C ol d  
_ _ _ H e at  
_ _ _ F ati g u e  
_ _ _ A n xi et y 
_ _ _ Ot h er ( d e s cri b e b el o w): 
 
 
W h at r eli e v e s t h e p ai n ? 
_ _ _ C ol d  
_ _ _ H e at  
_ _ _ E x er ci s e 
_ _ _ E ati n g 
_ _ _ M e di c ati o n s 
_ _ _ H er b al s 
_ _ _ A dj u v a nt s 
_ _ _ M a s s a g e 
_ _ _ R el a x ati o n  
_ _ _ R e st 
_ _ _ R e p o siti o ni n g 
_ _ _ Di str a cti o n 
 
 
R at e h o w t h e p ai n h a s h a d a n eff e ct i n e a c h ar e a i n t h e p a st 2 4 h o ur s: 
_ _ _ 0 or n o eff e ct 
_ _ _ 2 or mil d eff e ct 
_ _ _ 5 or m o d er at e eff e ct 
_ _ _ 1 0 s e v er e eff e ct 
 
I n t h e p a st 2 4 h o ur s, h o w m u c h h a v e t h e m e di c ati o n s or tr e at m e nt s e a s e d y o ur p ai n ? 
_ _ _ 0 or n o r eli ef 
_ _ _ 2 or mil d r eli ef 
_ _ _ 8 or r eli ef 
_ _ _ 1 0 or c o m pl et e r eli ef