PMID- 20569501 OWN - NLM STAT- MEDLINE DCOM- 20101124 LR - 20211020 IS - 1478-6362 (Electronic) IS - 1478-6354 (Print) IS - 1478-6354 (Linking) VI - 12 IP - 3 DP - 2010 TI - 74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis. PG - R121 LID - 10.1186/ar3058 [doi] AB - INTRODUCTION: The objective was to describe the prevalence, types, and predictors of adverse events (AEs) in rheumatoid arthritis (RA) patients treated with infliximab and methotrexate in a daily clinical setting. METHODS: This was a prospective, multi-center, open-label, 74-week observational study in patients with active RA despite treatment with methotrexate and at least one other disease-modifying anti-rheumatic drug. Patients were treated with 3 mg/kg infliximab at weeks 0, 2, and 6 and then every 8 weeks. At weeks 0, 6, 26, 50, and 74, patients answered a health assessment questionnaire, a swollen joint count was made, and adverse events (AEs) occurring during the previous period were registered. RESULTS: Five hundred and seventy-five patients were treated with infliximab, of which 346 were still on infliximab at the study end, 158 discontinued treatment, and 71 were lost to follow-up. Reasons for discontinuation included safety (n=74), elective reasons (n=43), and inefficacy (n=41). Infusion reactions (n=33) and infections (n=20) were the most common AEs causing discontinuation and the most common AEs overall. There were four cases of tuberculosis, all of which occurred in patients negative at screening. Total AEs, serious AEs, and infusion reactions as well as discontinuations for AEs were most frequent during the first 26 weeks. Higher age was a predictor of serious adverse events (SAEs), infection, and discontinuation due to an SAE, but odds ratios were close to one. CONCLUSIONS: AEs and discontinuations due to AEs occur most frequently during the first half year of infliximab treatment in refractory RA patients. The main reasons for discontinuing treatment are infections and infusion reactions. Tuberculosis and other infections remain an important concern in these patients. FAU - Delabaye, Isabelle AU - Delabaye I AD - Department of Immunology, Schering-Plough nv, 73 Rue de Stalle, Brussels 1180, Belgium. FAU - De Keyser, Filip AU - De Keyser F CN - REMITRACT study group LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20100622 PL - England TA - Arthritis Res Ther JT - Arthritis research & therapy JID - 101154438 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antirheumatic Agents) RN - 0 (Tumor Necrosis Factor-alpha) RN - B72HH48FLU (Infliximab) RN - YL5FZ2Y5U1 (Methotrexate) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal/*adverse effects/*therapeutic use MH - Antirheumatic Agents/*adverse effects/*therapeutic use MH - Arthritis, Rheumatoid/*drug therapy MH - Bacterial Infections/epidemiology MH - Drug Therapy, Combination MH - Female MH - Follow-Up Studies MH - Health Surveys MH - Humans MH - Infliximab MH - Longitudinal Studies MH - Male MH - Methotrexate/therapeutic use MH - Middle Aged MH - Prevalence MH - Prospective Studies MH - Treatment Outcome MH - Tumor Necrosis Factor-alpha/antagonists & inhibitors PMC - PMC2911915 FIR - Ackerman, C IR - Ackerman C FIR - Andre, B IR - Andre B FIR - Badot, V IR - Badot V FIR - Bailleul, Y IR - Bailleul Y FIR - Bentin, J IR - Bentin J FIR - Berghs, H IR - Berghs H FIR - Brasseur, J P IR - Brasseur JP FIR - Castro, S IR - Castro S FIR - Cheroutre, G IR - Cheroutre G FIR - Coigne, E IR - Coigne E FIR - Coppens, M IR - Coppens M FIR - Corluy, L IR - Corluy L FIR - Cornet, Fr IR - Cornet F FIR - Courtois, C IR - Courtois C FIR - Coutellier, P IR - Coutellier P FIR - Dall Armellina, S IR - Dall Armellina S FIR - Daumerie, F IR - Daumerie F FIR - De Brabanter, G IR - De Brabanter G FIR - De Clercq, L IR - De Clercq L FIR - De Decker, V IR - De Decker V FIR - De Graeve, B IR - De Graeve B FIR - De Vlam, K IR - De Vlam K FIR - Declerck, K IR - Declerck K FIR - Dhondt, E IR - Dhondt E FIR - Di Romana, S IR - Di Romana S FIR - Docquier, C IR - Docquier C FIR - Dufour, J P IR - Dufour JP FIR - Dumont, M IR - Dumont M FIR - Durez, P IR - Durez P FIR - Engelbeen, J P IR - Engelbeen JP FIR - Fernandez Lopez, M J IR - Fernandez Lopez MJ FIR - Francois, D IR - Francois D FIR - Geusens, P IR - Geusens P FIR - Ghyselen, G IR - Ghyselen G FIR - Goemaere, S IR - Goemaere S FIR - Goethals, L IR - Goethals L FIR - Golstein, M IR - Golstein M FIR - Gyselbrecht, L IR - Gyselbrecht L FIR - Halleux, R IR - Halleux R FIR - Herman, H IR - Herman H FIR - Hermanns, P IR - Hermanns P FIR - Heuse, E IR - Heuse E FIR - Heylen, A IR - Heylen A FIR - Immesoete, C IR - Immesoete C FIR - Itzkowitch, D IR - Itzkowitch D FIR - Janssens, X IR - Janssens X FIR - Jeukens, T IR - Jeukens T FIR - Joos, R IR - Joos R FIR - Kaiser, M-J IR - Kaiser MJ FIR - Langenaken, C IR - Langenaken C FIR - Lefebvre, S IR - Lefebvre S FIR - Lenaerts, J IR - Lenaerts J FIR - Leon, M IR - Leon M FIR - Luyten, H IR - Luyten H FIR - Maenaut, K IR - Maenaut K FIR - Maertens, M IR - Maertens M FIR - Maeyaert, B IR - Maeyaert B FIR - Martin, F IR - Martin F FIR - Moens, Ph IR - Moens P FIR - Pater, C IR - Pater C FIR - Poriau, S IR - Poriau S FIR - Praet, J IR - Praet J FIR - Raeman, F IR - Raeman F FIR - Ravelingien, I IR - Ravelingien I FIR - Ribbens, C IR - Ribbens C FIR - Ronsmans, I IR - Ronsmans I FIR - Schatteman, L IR - Schatteman L FIR - Schreiber, S IR - Schreiber S FIR - Stappaerts, G IR - Stappaerts G FIR - Stasse, P IR - Stasse P FIR - Stuer, A IR - Stuer A FIR - Van Bruwaene, F IR - Van Bruwaene F FIR - Van Den Berghe, M IR - Van Den Berghe M FIR - Van Den Bosch, F IR - Van Den Bosch F FIR - Van den Bossche, N IR - Van den Bossche N FIR - Van Essche, E IR - Van Essche E FIR - Van Wanghe, P IR - Van Wanghe P FIR - Vanden Berghe, M IR - Vanden Berghe M FIR - Vanhoof, J IR - Vanhoof J FIR - Vanneuville, B IR - Vanneuville B FIR - Villers, C IR - Villers C FIR - Volders, P IR - Volders P FIR - Vroninks, P IR - Vroninks P FIR - Walravens, M IR - Walravens M FIR - Williame, L IR - Williame L FIR - Wouters, M IR - Wouters M FIR - Zmierczak, H G IR - Zmierczak HG FIR - Appelboom, T IR - Appelboom T FIR - Boutsen, Y IR - Boutsen Y FIR - De Clerck, L IR - De Clerck L FIR - Devogelaer, J P IR - Devogelaer JP FIR - Veys, E M IR - Veys EM FIR - Houssiau, F IR - Houssiau F FIR - Mielants, H IR - Mielants H FIR - Peretz, A IR - Peretz A FIR - Steinfeld, S IR - Steinfeld S FIR - Verbruggen, G IR - Verbruggen G FIR - Verbruggen, L IR - Verbruggen L FIR - Westhovens, R IR - Westhovens R EDAT- 2010/06/24 06:00 MHDA- 2010/12/14 06:00 PMCR- 2010/06/22 CRDT- 2010/06/24 06:00 PHST- 2009/10/29 00:00 [received] PHST- 2010/03/17 00:00 [revised] PHST- 2010/06/22 00:00 [accepted] PHST- 2010/06/24 06:00 [entrez] PHST- 2010/06/24 06:00 [pubmed] PHST- 2010/12/14 06:00 [medline] PHST- 2010/06/22 00:00 [pmc-release] AID - ar3058 [pii] AID - 10.1186/ar3058 [doi] PST - ppublish SO - Arthritis Res Ther. 2010;12(3):R121. doi: 10.1186/ar3058. Epub 2010 Jun 22.