Clinical trial NCT01877668: Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: psoriatic arthritis
radiographic changes
active comparator
tofacitinib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-06-14
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.


Eligibility criteria: Inclusion Criteria:

* Males or females, aged \>= 18 years at time of consent.
* Have a diagnosis of Psoriatic arthritis (PsA) of \>= 6 months
* Meet the Classification Criteria of PsA (CASPAR) at time of screening
* Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
* Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
* Must not have taken a biologic Tumour Necrosis Factor Inhibitor
* Must have 3 or more swollen joints AND 3 or more tender joints
* Must have active psoriasis skin lesions

Exclusion Criteria:

* Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
* Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
* New York Heart Association Class III and IV congestive heart failure
* History of hypersensitivity or infusion reaction to biologic agents
* Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection

Primary outcomes:
measure: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3
timeFrame: At end of Month 3
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
timeFrame: From Baseline to Month 3
Secondary outcomes:
measure: Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis
timeFrame: From Baseline to Month 12
measure: Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12
timeFrame: At Month 12
measure: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
timeFrame: At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
measure: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
timeFrame: At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
measure: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12
timeFrame: At Week 2 and Months 1, 2, 4, 6, 9, and 12
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
timeFrame: From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12
measure: Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels
timeFrame: From Baseline to end of Month 3
measure: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain
timeFrame: From Baseline to end of Month 3
measure: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis
timeFrame: From Baseline to end of Month 3
measure: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis
timeFrame: From Baseline to end of Month 3
measure: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count
timeFrame: From Baseline to end of Month 3
measure: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count
timeFrame: From Baseline to end of Month 3
measure: Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
timeFrame: At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
measure: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12
timeFrame: At Months 1, 3, 6, 9, and 12
measure: Change From Baseline in Dactylitis Severity Score (DSS)
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in the Leeds Enthesitis Index (LEI)
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
measure: Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: From Baseline to Months 1, 3, 6, 9, and 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Rheumatology Associates, PC
state: Alabama
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama, PC
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Rancho Mirage
country: United States
facility: Advances In Medicine (X-Rays)
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Medical Clinic
state: California
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center, Inc.
state: Florida
city: Hagerstown
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Eagan
country: United States
facility: St. Paul Rheumatology, PA
state: Minnesota
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center (DHMC)
state: New Hampshire
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital & Clinics
state: Utah
city: Seattle
country: United States
facility: Dynacare Laboratories (Specimen processing for shipment)
state: Washington
city: Seattle
country: United States
facility: Investigational Drug Service Pharmacy, Swedish Medical Center.
state: Washington
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit
state: Queensland
city: Southport
country: Australia
facility: Pacific Private Clinic
state: Queensland
city: Clayton
country: Australia
facility: Monash Health, Monash Medical Centre
state: Victoria
city: Clayton
country: Australia
facility: Pharmacy Clinical Trials
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital (Melbourne)
state: Victoria
city: Malvern East
country: Australia
facility: Emeritus Research Pty Ltd
state: Victoria
city: Brussels
country: Belgium
facility: Hopital Erasme - Clinique Universitaire de Bruxelles
city: Leuven
country: Belgium
facility: University Hospital Leuven, Department of Rheumatology
city: Pleven
country: Bulgaria
facility: UMHAT "Dr. G. Stranski" EAD
city: Plovdiv
country: Bulgaria
facility: MHAT"Plovdiv" AD
city: Plovdiv
country: Bulgaria
facility: MHAT "Kaspela" EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski" EAD
city: Stara Zagora
country: Bulgaria
facility: MC "New rehabilitation center" EOOD, Rheumatology Cabinet
city: Edmonton
country: Canada
facility: Rheumatology Research Associates
state: Alberta
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Pointe-Claire
country: Canada
facility: West Island Rheumatology Research Associates
state: Quebec
city: Brno
country: Czechia
facility: Revmacentrum MUDr. Mostera, s.r.o.
state: Czech Republic
city: Praha 1 - Nove Mesto
country: Czechia
facility: MEDIGAP, s.r.o. (radiology only)
state: Czech Republic
city: Praha 2
country: Czechia
facility: Revmatologicky Ustav - Lekarna (pharmacy only)
state: Czech Republic
city: Praha 4
country: Czechia
facility: Revmatologicka ambulance
state: Czech Republic
city: Brno
country: Czechia
facility: Lekarna Na Lidicke (Pharmacy only)
city: Brno
country: Czechia
facility: X-MEDICA s.r.o (radiology only)
city: Brno
country: Czechia
facility: Revmatologie s.r.o.
city: Brno
country: Czechia
facility: Stavovska s.r.o. (pharmacy only)
city: Ostrava
country: Czechia
facility: Vesalion s.r.o.
city: Praha 1- Nove Mesto
country: Czechia
facility: MEDIGAP, s.r.o
city: Praha 2
country: Czechia
facility: Revmatologicky ustav - Lekarna
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Uherske Hradiste
country: Czechia
facility: Medical Plus s.r.o. Lekarna Hradebni s. r.o
city: Corbeil Essonnes cedex
country: France
facility: Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: Rheumapraxis Steglitz
city: Koeln
country: Germany
facility: University Hospital of Cologne
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Budapest
country: Hungary
facility: Revita Reumatologiai Rendelo
city: Budapest
country: Hungary
facility: Qualiclinic Kft.
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly
city: Veszprem
country: Hungary
facility: Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only
city: Veszprem
country: Hungary
facility: Csolnoky Ferenc Korhaz, Reumatologiai Osztaly
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia SA de CV
state: Jalisco
city: Culiacan
country: Mexico
facility: Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.
state: Sinaloa
city: Culiacan
country: Mexico
facility: Laboratorios de Analisis Clinicos CEMSI
state: Sinaloa
city: Culiacan
country: Mexico
facility: Sanatorio CEMSI Chapultepec (For Emergencies Only)
state: Sinaloa
city: Culiacan
country: Mexico
facility: Hospital General de Culiacán Dr. Bernardo J. Gastélum
state: Sinaloa
city: Merida
country: Mexico
facility: Instituto Medico Panamericano, S.A. de C.V. (For Emergencies Only)
state: Yucatan
city: Merida
country: Mexico
facility: Unidad Reumatologica Las Americas, S.C.P.
state: Yucatan
city: Merida
country: Mexico
facility: Centro de Investigacion Clinica Pensiones
state: Yucatan
city: Merida
country: Mexico
facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
state: Yucatan
city: Merida
country: Mexico
facility: Hospital Star Medica Merida (For Emergencies Only)
state: Yucatan
city: Merida
country: Mexico
facility: HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only)
state: Yucatan
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua SC
city: Mexico City
country: Mexico
facility: Cliditer, S. A. de C. V
city: Bialystok
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.,"
city: Bialystok
country: Poland
facility: ZDROWIE OSTEO-MEDIC s.c. L. i A. Racewicz, A. i J. Supronik
city: Bialystok
country: Poland
facility: ClinicMed Badurski i wspolnicy Spolka Jawna
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
city: Elblag
country: Poland
facility: Centrum Radiologii for X-Ray only
city: Elblag
country: Poland
facility: NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
city: Grodzisk Mazowiecki
country: Poland
facility: Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"
city: Lublin
country: Poland
facility: Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED S.C.
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj
city: Torun
country: Poland
facility: NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
city: Warsaw
country: Poland
facility: Medica Pro Familia Sp. z o.o. S.K.A.
city: Warszawa
country: Poland
facility: Rheuma Medicus Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: Reumatika Centrum Reumatologii
city: Warszawa
country: Poland
facility: Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddz. we Wroclawiu
city: Petrozavodsk
country: Russian Federation
facility: Regional State Budgetary Healthcare Institution of Karelia Republic
state: Karelia Republic
city: Moscow
country: Russian Federation
facility: State Budgetary Institution of Healthcare of Moscow City Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: OOO City Neurological Centre "Sibneiromed"
city: Novosibirsk
country: Russian Federation
facility: Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
city: Saratov
country: Russian Federation
facility: State Institution of Healthcare "Regional Clinical Hospital"
city: Tomsk
country: Russian Federation
facility: State Budget Educational Institution of Highest Professional Education
city: Yaroslavl
country: Russian Federation
facility: State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev
city: Yaroslavl
country: Russian Federation
facility: State Institution of Healthcare of Yaroslavl Region
city: Bratislava
country: Slovakia
facility: ROMJAN s.r.o., Reumatologicka ambulancia
state: Slovak Republic
city: Martin
country: Slovakia
facility: MEDMAN s.r.o. - reumatologicka ambulancia
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Nestatna reumatologicka ambulancia
city: Rimavska Sobota
country: Slovakia
facility: Reumex s.r.o
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico de Santiago
state: A Coruna
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Tauli
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: A Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruna
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
state: Taiwan Roc
city: Chia-Yi
country: Taiwan
facility: Buddhist Dalin Tzu Chi General Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation-Kaohsiung Branch
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Goodmayes
country: United Kingdom
facility: Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital
state: Essex
city: Romford
country: United Kingdom
facility: Barking, Havering and Redbridge University Hospitals NHS Trust
state: Essex
city: Dudley
country: United Kingdom
facility: The Dudley Group NHS Foundation Trust
state: West Midlands
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
state: West Yorkshire
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary, BTHFT
state: West Yorkshire
city: Upton
country: United Kingdom
facility: Wirral University Teaching Hospital NHS Foundation Trust
state: Wirral
city: York
country: United Kingdom
facility: York Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: de Vlam K, Mease PJ, Bushmakin AG, Fleischmann R, Ogdie A, Azevedo VF, Merola JF, Woolcott J, Cappelleri JC, Fallon L, Taylor PC. Identifying and Quantifying the Role of Inflammation in Pain Reduction for Patients With Psoriatic Arthritis Treated With Tofacitinib: A Mediation Analysis. Rheumatol Ther. 2022 Oct;9(5):1451-1464. doi: 10.1007/s40744-022-00482-5. Epub 2022 Sep 8.
citation: Orbai AM, Mease PJ, Helliwell PS, FitzGerald O, Fleishaker DL, Mundayat R, Young P. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies. BMC Rheumatol. 2022 Sep 1;6(1):68. doi: 10.1186/s41927-022-00298-4.
citation: Taylor PC, Bushmakin AG, Cappelleri JC, Young P, Germino R, Merola JF, Yosipovitch G. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatolog Treat. 2022 Aug;33(5):2614-2620. doi: 10.1080/09546634.2022.2060924. Epub 2022 Apr 11.
citation: Gladman DD, Coates LC, Wu J, Fallon L, Bacci ED, Cappelleri JC, Bushmakin AG, Helliwell PS. Time to response for clinical and patient-reported outcomes in patients with psoriatic arthritis treated with tofacitinib, adalimumab, or placebo. Arthritis Res Ther. 2022 Feb 9;24(1):40. doi: 10.1186/s13075-022-02721-0.
citation: Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.
citation: Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
citation: Kivitz AJ, FitzGerald O, Nash P, Pang S, Azevedo VF, Wang C, Takiya L. Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials. Clin Rheumatol. 2022 Feb;41(2):499-511. doi: 10.1007/s10067-021-05894-2. Epub 2021 Sep 12.
citation: de Vlam K, Ogdie A, Bushmakin AG, Cappelleri JC, Fleischmann R, Taylor PC, Azevedo V, Fallon L, Woolcott J, Mease PJ. Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib. RMD Open. 2021 Jul;7(2):e001609. doi: 10.1136/rmdopen-2021-001609.
citation: Coates LC, Bushmakin AG, FitzGerald O, Gladman DD, Fallon L, Cappelleri JC, Hsu MA, Helliwell PS. Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib. Arthritis Res Ther. 2021 Mar 26;23(1):94. doi: 10.1186/s13075-021-02474-2.
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