natgillin/translations-raw huggingface dataset:
Inflectra kan opbevares ved temperaturer på op til højst 25°C i en enkelt periode på op til 6 måneder, men den oprindelige udløbsdato må ikke overskrides.
Inflectra may be stored at temperatures up to a maximum of 25 °C for a single period of up to 6 months, but not exceeding the original expiry date.
Induktionsbehandling af fistulerende, aktiv Crohns sygdom Virkningen blev også vurderet i et randomiseret, dobbeltblindet, placebokontrolleret studie hos 94 patienter med fistulerende Crohns sygdom, som havde fistler af mindst 3 måneders varighed.
Induction treatment in fistulising active Crohn's disease The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn's disease who had fistulae that were of at least 3 months' duration.
I kliniske studier af reumatoid arthritis var hyppigheden af alvorlige infektioner højere hos infliximabplus methotrexatbehandlede patienter på 65 år og derover (11,3%) sammenlignet med patienter under 65 år (4,6%).
In rheumatoid arthritis clinical studies, the incidence of serious infections was greater in infliximab plus methotrexate-treated patients 65 years and older (11.3%) than in those under 65 years of age (4.6%).
Hvis disse lægemidler ikke virker godt nok, vil du få Inflectra til behandling af din sygdom.
If these medicines do not work well enough, you will be given Inflectra to treat your disease.
• Øvrige indholdsstoffer: saccharose, polysorbat 80, natriumdihydrogen-phosphatmonohydrat og dinatriumphosphatdihydrat.
• The other ingredients are sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate and disodium phosphate dihydrate.
Total score d (van der Heijdemodified Sharp score) Ændring fra baseline (Gennemsnit ± SD
(van der Heijde-modified Sharp score) Change from baseline (Mean ± SD c)
I det andet kliniske studie (IMPACT 2) blev virkning og sikkerhed af infliximab undersøgt hos 200 patienter med aktiv psoriasis arthritis (≥ 5 hævede led og ≥ 5 ømme led).
In the second clinical study (IMPACT 2), efficacy and safety of infliximab were studied in 200 patients with active psoriatic arthritis (≥ 5 swollen joints and ≥ 5 tender joints).
I uge 12 var antallet af BASDAI 50 respondere 3/35 (9%) i placebogruppen og 20/35 (57%) i 5 mg/kg gruppen (p < 0,01).
At week 12, the number of BASDAI 50 responders were 3/35 (9%) in the placebo group, and 20/35 (57%) in the 5 mg/kg group (p<0.01).
• Tegn på alvorlige hudproblemer såsom rødlige, målskivelignende pletter eller runde områder ofte med blærer centralt på kroppen, store områder med afskalning af huden (eksfoliation), sår i mund, svælg, næse, kønsorganer og øjne eller små pusholdige blærer, som kan sprede sig over hele kroppen.
• Signs of serious skin problems such as reddish-target-like spots or circular patches often with central blisters on the trunk, large areas of peeling and shedding (exfoliating) skin, ulcers of mouth, throat, nose, genitals and eyes or small pus-filled bumps that can spread over the body.
Hos patienter med allerede eksisterende eller nyligt opståede demyeliniseringssygdomme skal vurdering af forventet gavn og risiko ved anti-TNF-behandlingen overvejes omhyggeligt før initiering af behandling med infliximab.
In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of infliximab therapy.
Placebo → Infliximab 5 mg/kg (i uge 24)
EXPRESS Placebo → Infliximab 5 mg/kg (at week 24)
• Før du får Inflectra, skal du fortælle det til din læge, hvis du har en lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL, rygerlunger), eller hvis du er storryger.
• Tell your doctor before you are given Inflectra if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker.
Opmærksomheden henledes på risikoen for falsk negative resultater af tuberkulintesten, især hos patienter, der er alvorligt syge eller immunsupprimerede.
It is recommended that the conduct of these tests should be recorded in the patient's reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Induktionsbehandling af moderat til svært aktiv Crohns sygdom Virkningen af en éndosis behandling med infliximab blev vurderet hos 108 patienter med aktiv Crohns sygdom (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) i et randomiseret, dobbeltblindet, placebokontrolleret, dosis-virknings studie.
Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double-blinded, placebo-controlled, dose-response study.
Kan opbevares ved almindelig temperatur (op til 25°C) i en enkelt periode på op til 6 måneder, men den oprindelige udløbsdato må ikke overskrides.
Can be stored at room temperature (up to 25 °C) for a single period up to 6 months, but not exceeding the original expiry date.
De alvorligste bivirkninger forbundet med brugen af TNF-blokkere, som er blevet rapporteret for infliximab, inkluderer HBV-reaktivering, CHF (hjerteinsufficiens), alvorlige infektioner (inklusive sepsis, opportunistiske infektioner og TB), serumsygdom (forsinkede overfølsomhedsreaktioner), hæmatologiske reaktioner, systemisk lupus erythematosus/lupus-lignende syndrom, demyeliniserende sygdomme, hepatobiliære bivirkninger, lymfomer, HSTCL, leukæmi, Merkelcellekarcinom, melanom, pædiatrisk malignitet, sarkoidose/sarkoid-lignende reaktion, byld i tarmen eller ved endetarmen (ved Crohns sygdom) og alvorlige infusionsreaktioner (se pkt.
The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4).
Det primære endepunkt var andelen af patienter, der oplevede en klinisk virkning, bestemt som ≥ 50% reduktion fra baseline i antallet af fistler, drænet ved forsigtigt tryk, ved mindst to på hinanden følgende besøg (med 4 ugers mellemrum) uden øget brug af lægemidler eller kirurgisk indgreb for Crohns sygdom.
The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥ 50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn's disease.
• Disse infektioner kan være alvorlige og indbefatte tuberkulose, infektioner forårsaget af virus, svampe, bakterier eller andre organismer, der findes i miljøet (infektioner som kun fremkommer, hvis du er særligt disponeret) samt blodforgiftning, som kan være livstruende.
• These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria or other organisms in the environment and sepsis that may, be life-threatening.
Du må ikke få Inflectra og Orencia samtidig.
Inflectra and Orencia should not be used together.
Infliximabs virkning og sikkerhed blev undersøgt i to multicenter, dobbelblindede, placebokontrollerede studier hos patienter med aktiv ankyloserende spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score≥ 4 og spinalsmerte ≥ 4 på en skala på 1-10)
Efficacy and safety of infliximab were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
I uge 30 var andelen af personer med klinisk remission højere i 8-ugers gruppen (59,6%; 31/52) end i 12-ugers gruppen (35,3%, 18/51; p=0,013).
At week 30, the proportion of subjects in clinical remission was higher in the q8 week (59.6%, 31/52) than the q12 week maintenance treatment group (35.3%, 18/51; p=0.013).
Anti-dsDNA antistoffer blev påvist første gang hos cirka 17% af infliximab-behandlede patienter sammenlignet med 0% af placebobehandlede patienter.
Anti-dsDNA antibodies were newly detected in approximately 17% of infliximab-treated patients compared with 0% of placebo-treated patients.
Opbevares ved 2°C - 8°C.
Store at 2 °C - 8 °C.
Samtidig administration af levende vacciner og infliximab frarådes.
The concurrent administration of live vaccines with infliximab is not recommended.
Patienterne fik 3 eller 6 mg/kg infliximab som et 3 dosis induktionsregi (hhv. uge 0, 2, 6 eller uge 14, 16, 20) fulgt af vedligeholdelsesbehandling hver 8. uge i kombination med methotrexat.
Patients received 3 or 6 mg/kg infliximab as a 3-dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20, respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Samtidig administration af TNF-alfahæmmere og abatacept har i kliniske studier været forbundet med en øget risiko for infektioner, inklusive alvorlige infektioner, uden en øget klinisk fordel, sammenlignet med TNF-hæmmere alene.
In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
Tabel 5 Virkninger på respons og remissionshastighed, data fra ACCENT I (uge-2 responderende)
Table 5 Effects on response and remission rate, data from ACCENT I (Week-2 responders) ACCENT I (Week-2 responders) % of Patients
Vedligeholdelsesbehandling af moderat til svært aktiv Crohns sygdom hos voksne Virkningen af gentagne infusioner med infliximab blev undersøgt i et 1-års klinisk studie (ACCENT I).
Maintenance treatment in moderately to severely active Crohn's disease in adults The efficacy of repeated infusions with infliximab was studied in a 1-year clinical study (ACCENT I).
Når TNF-blokerende behandling overvejes, bør forsigtighed udvises hos patienter med en fortid med maligne sygdomme, eller når fortsat behandling overvejes hos patienter, der udvikler maligne sygdomme.
Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.
Infliximab Vedligeholdelse (5 mg/kg) (n=96)
Infliximab Maintenance (5 mg/kg) (n=96)
Under behandling med Inflectra
During treatment with Inflectra
Følgende bivirkninger forekom hyppigere hos børn: nedsat antal røde blodlegemer (anæmi), blod i afføringen, generelt nedsat antal hvide blodlegemer (leukopeni), anfaldsvis ansigtsrødme, virussinfektioner, lavt antal hvide blodlegemer, der bekæmper infektion (neutropeni), knoglebrud, bakterieinfektion og allergiske reaktioner i luftvejene.
The side effects that happened more in children were: low red blood cells (anaemia), blood in stool, low overall levels of white blood cells (leukopenia), redness or blushing (flushing), viral infections, low levels of white blood cells that fight infection (neutropenia), bone fracture, bacterial infection and allergic reactions of the breathing tract.
De foreliggende data understøtter ikke yderligere infliximab-behandling af børn og unge, som ikke responderer inden for de første 10 ugers behandling (se pkt.
Available data do not support further infliximab treatment in children and adolescents not responding within the first 10 weeks of treatment (see section 5.1).
Fortsat behandling bør revurderes nøje hos patienter, som ikke viser tegn på klinisk fordel inden for de første 12 ugers behandling eller efter dosisjustering.
Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment or after dose adjustment.
Det påkrævede volumen af den rekonstituerede Inflectra-opløsning fortyndes til 250 ml med natriumchlorid 9 mg/ml (0,9%) infusionsvæske.
The required volume of the reconstituted Inflectra solution should be diluted to 250 mL with sodium chloride 9 mg/mL (0.9%) solution for infusion.
Inflectra er indiceret til behandling af moderat til svær plaque psoriasis hos voksne patienter, som ikke responderede på, eller som har en kontraindikation for eller som ikke tåler anden systemisk behandling inklusive ciclosporin, methotrexat eller psoralen ultra-violet A (PUVA) (se pkt.
Inflectra is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Immunogenicitet Der blev påvist antistoffer overfor infliximab hos 3 (2,9%) af børnene.
Immunogenicity Antibodies to infliximab were detected in 3 (2.9%) paediatric patients.
• behandle aktiv Crohns sygdom
• treat active Crohn's disease,
Hvis disse lægemidler ikke virker godt nok, vil du få Inflectra for at:
If these medicines do not work well enough, you will be given Inflectra to:
De bivirkninger, som børn i behandling med infliximab mod Crohns sygdom fik, var forskellige fra de bivirkninger, som voksne i behandling med infliximab mod Crohns sygdom fik.
Additional side effects in children and adolescents Children who took infliximab for Crohn's disease showed some differences in side effects compared with adults who took infliximab for Crohn's disease.
• Tegn på leverproblemer (inklusive hepatitis B-infektion, hvis du tidligere har haft hepatitis B) såsom gulfarvning af hud eller øjne, mørkebrun urin, smerte eller hævelse i øvre højre side af maven, ledsmerter, hududslæt eller feber.
• Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past) such as yellowing of the skin or eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
Uge 54 Klinisk respons
Week 54 Clinical Response a
Infliximabs sikkerhed og virkning blev vurderet i et multicenter, randomiseret, open-label, parallelgruppe klinisk studie (C0168T72) hos 60 pædiatriske patienter i alderen 6 til 17 år (medianalder 14,5 år) med moderat til svær aktiv colitis ulcerosa (Mayo-score på 6-12; endoskopisk subscore ≥ 2) med utilstrækkeligt respons på konventionel behandling.
The safety and efficacy of infliximab were assessed in a multicentre, randomised, open-label, parallel-group clinical study (C0168T72) in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Der blev rapporteret infektioner hos 56,3% af de randomiserede personer behandlet med infliximab i REACH studiet.
In the REACH study, infections were reported in 56.3% of randomised subjects treated with infliximab.
Tabel 3 Virkninger på ACR20, strukturel ledskade og fysisk funktionsevne ved uge 54, ATTRACT
Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT Infliximab b
I uge 54 var andelen af patienter i klinisk remission målt ved PUCAI-scoren 38% (8/21) i 8-ugers vedligholdelsesbehandlingsgruppen og 18% (4/22) i 12-ugers vedligeholdelsesbehandlingsgruppen.
At week 54, the proportion of patients in clinical remission as measured by the PUCAI score was 38% (8/21) in the q8 week maintenance group and 18% (4/22) in the q12 week maintenance treatment group.
I det andet kliniske studie (ASSERT) blev 279 patienter randomiseret til behandling med enten placebo (gruppe 1, n=78) eller 5 mg/kg infliximab (gruppe 2, n=201) i uge 0, 2 og 6 og derefter hver 6. uge indtil uge 24.
In the second clinical study (ASSERT), 279 patients were randomised to receive either placebo (Group 1, n=78) or 5 mg/kg infliximab (Group 2, n=201) at 0, 2 and 6 weeks and every 6 weeks to week 24.
Der var færre forsøgspersoner, som fik foretaget kolektomi i 5 mg/kg infliximabgruppen (28/242 eller 11,6% [N.S.] og 10 mg/kg infliximab-gruppen (18/242 eller 7.4% [p=0,011]) end i placebogruppen (36/244;14,8%).
Fewer subjects underwent colectomy in the 5 mg/kg infliximab group (28/242 or 11.6% [N.S.]) and the 10 mg/kg infliximab group (18/242 or 7.4% [p=0.011]) than in the placebo group
Dit barn bør ikke få levende vacciner, som BCG, indenfor 6 måneder efter fødslen.
Live vaccines such as BCG should not be given to your baby within 6 months after birth.
Sikkerhed og virkning ved infliximab blev vurderet i to (ACT 1 og ACT 2) randomiserede, dobbeltblindede, placebokontrollerede kliniske studier hos voksne patienter med moderat til svær, aktiv colitis ulcerosa (Mayo score 6 til 12; Endoskopi subscore ≥ 2) med et utilstrækkeligt respons på konventionel behandling [orale kortikosteroider, aminosalicylater og/eller immunmodulatorer (6-MP, AZA)].
The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
• Fornyet administration: Infusion af 5 mg/kg, hvis sygdomstegn og symptomer på sygdommen kommer igen (se ‘Fornyet administration' nedenfor samt pkt.
• Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur (see
Hypotension, hypertension, ekkymose, hedeture, rødmen.
Hypotension, hypertension, ecchymosis, hot flush, flushing.
En større andel patienter i den kombinerede infliximab-behandlingsgruppe var i stand til at afbryde kortikosteroider og stadig blive i klinisk remission sammenlignet med placebobehandlingsgruppen i både uge 30 (22,3% mod 7,2%, p < 0,001, samlede ACT 1 & ACT 2 data) og uge 54 (21,0% mod 8,9%, p=0,022, ACT 1 data).
A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p <0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data).
Virkningen af samtidig behandling med immunmodulatorer var mere udtalt hos patienter behandlet periodevist i forhold til patienter i vedligeholdelsesbehandling.
The effect of concomitant immunomodulator therapy was more profound in episodically-treated patients than in patients given maintenance therapy.
Tabel 1 viser de bivirkninger, som er set i kliniske studier, såvel som de bivirkninger, som er set efter markedsføring, heraf er nogle dødelige.
Table 1 lists the ADRs based on experience from clinical studies as well as adverse reactions, some with fatal outcome, reported from post-marketing experience.
De foreliggende data understøtter ikke yderligere infliximab-behandling hos pædiatriske patienter, som ikke responderer inden for de første 8 ugers behandling (se pkt.
Available data do not support further infliximab treatment in paediatric patients not responding within the first 8 weeks of treatment (see section 5.1).
• Du må ikke amme, mens du er i behandling med Inflectra og i mindst 6 måneder efterdin sidste behandling med Inflectra.
• Do not breast-feed when you are being treated with Inflectra or for 6 months after your last treatment with Inflectra.
Næsten alle patienterne havde, i tillæg til TNF-blokkere, også fået lægemidler, der indeholder azathioprin eller mercaptopurin.
Almost all patients had also received medicines containing azathioprine or mercaptopurine in addition to TNF-blockers.
Tegn omfatter gulfarvning af hud og øjne, mørkebrun urin, smerter eller hævelse i øvre højre side af maven, ledsmerter, udslæt eller feber.
Signs include yellowing of the skin and eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
Infliximabvedligeholdelse 5 mg/kg (n=113) (p-værdi)
Infliximab Maintenance 5 mg/kg (n=113) (p value)
Vedligeholdelsesbehandling af fistulerende, aktiv Crohns sygdom Virkningen af gentagne infusioner med infliximab hos patienter med fistulerende Crohns sygdom blev undersøgt i et 1-års klinisk studie (ACCENT II).
Maintenance treatment in fistulising active Crohn's disease The efficacy of repeated infusions with infliximab in patients with fistulising Crohn's disease was studied in a 1-year clinical study (ACCENT II).
Efter markedsføring er hændelser af anafylaktisk lignende reaktioner, inklusive strube/spiserørs ødemer og alvorlige bronkospasmer, og kramper blevet forbundet med administration af infliximab (se pkt.
In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with infliximab administration (see section 4.4).
Seponering af infliximab-behandling bør overvejes hos patienter, hvor signifikante blodanormaliteter er bekræftet.
Discontinuation of infliximab therapy should be considered in patients with confirmed significant haematologic abnormalities.
Ydermere er der efter markedsføring blevet rapporteret tilfælde af hepatosplenisk T-celle-lymfom hos patienter, behandlet med infliximab, hvor størstedelen af tilfældene opstår med Crohns sygdom og colitis ulcerosa, og de fleste var hos unge eller unge voksne mænd (se pkt.
In addition, post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with infliximab with the vast majority of cases occurring in Crohn's disease and ulcerative colitis, and most of whom were adolescent or young adult males (see section 4.4).
Infliximabvedligeholdelse 10 mg/kg (n=112) (p-værdi)
Infliximab Maintenance 10 mg/kg (n=112) (p value)
68 procent (21/31)af patienter behandlet med infliximab, der fik et 5 mg/kg doseringsregimen, opnåede en klinisk virkning mod 26% (8/31) af placebobehandlede patienter (p = 0,002).
Sixty-eight percent (21/31) of infliximab-treated patients receiving a 5 mg/kg dose regimen achieved a clinical response vs. 26% (8/31) placebo-treated patients (p=0.002).
• Hudproblemer såsom blæredannelse, vorter, unormal hudfarve eller pigmentering, eller hævede læber eller fortykkelse af huden eller rød, skællende hud og afskalning af huden
• Skin problems such as blistering, warts, abnormal skin colouration or pigmentation, or swollen lips, or thickening of the skin, or red, scaly, and flaky skin
I uge 24 var antallet af ASAS 20 respondere 15/78 (19%) i placebogruppen og 123/201 (61%) i gruppen, der fik 5 mg/kg infliximab (p < 0,001).
At week 24, the number of ASAS 20 responders was 15/78 (19%) in the placebo group, and 123/201 (61%) in the 5 mg/kg infliximab group (p<0.001).
I det første studie (P01522), som havde en dobbelblindet fase på 3 måneder, modtog 70 patienter enten 5 mg/kg infliximab eller placebo i uge 0, 2, 6 (35 patienter i hver gruppe).
In the first study (P01522), which had a 3 month double-blind phase, 70 patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6 (35 patients in each group).
I et toksicitetsstudie vedrørende udvikling udført på mus med et analogt antistof, som selektivt hæmmer den funktionelle aktivitet af muse-TNFα, var der ingen tegn på maternal toksicitet, embryotoksicitet eller teratogenicitet (se pkt.
In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, there was no indication of maternal toxicity, embryotoxicity or teratogenicity (see section 5.3).
I fase III kliniske studier oplevede 18% af de infliximab-behandlede patienter en infusionsrelateret reaktion sammenlignet med 5% af de placebobehandlede patienter.
In phase III clinical studies, 18% of infliximab-treated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction.