Background Infliximab is well-established tumor necrosis factor α inhibitor in management of rheumatoid arthritis (RA). It has shown efficacy in many randomized controlled clinical trials and registries.
Objectives To assess the efficacy of infliximab in patients with RA in routine clinical practice in the Czech Republic and to define the predictive value of results at 10 weeks of therapy for the outcomes at the end of the first year of treatment.
Methods We retrospectively analyzed data of 487 patients with RA treated with infliximab as their first biological agent with at least 1 year follow-up. This cohort of patients was enrolled in the years 2001-2010. We obtained the data from the National Biological Therapy Registry (ATTRA) in the Czech Republic. All patients fulfilled the revised ACR 1987 criteria for diagnosis of RA and met the Czech Society of Rheumatology Guidelines (failure of ≥2 previous disease modifying antirheumatic drugs and DAS 28 >5,1). The primary outcome measures were Disease Activity Score 28 (DAS 28), EULAR (European League Against Rheumatism) response and Health Assessment Questionaire (HAQ) Score. We collected the data at baseline, after 10 and 54 weeks. Infliximab was administered intravenously at 0,2,6 and every 8 weeks thereafter, at dose 3 mg/kg with possibility of dose escalation to 6 mg/kg.
Results There were 363 women and 124 men with a mean age of 45.5±14.2 years and disease duration of 10.7±8.0 years. Ater 10 weeks, 447 out of 463 patients (96.6%) achieved an EULAR response (28.1% good, 68.5% moderate), 16 (3.4%) failed to achieve an EULAR response, 73 (15.6%) were in remission (DAS 28 <2.6) and 133 (28.5%) were in low disease activity (LDA) state (DAS 28 <3.2). The mean decrease in DAS 28 was 2.5 (6.5 -0.2, p<0.001) after 10 weeks of therapy. The mean HAQ Score reduced from 1.5 (0-2.88, p<0.001) at baseline to 1.00 (0-3.00) at 10 weeks and the reduction was maintained till the end of the first year of therapy. Ater 54 weeks, 399 out of 437 patients (91.3%) achieved an EULAR response (32.3% good, 59.0% moderate), 38 (8.7%) failed to achieve an EULAR response, 77 (17.5%) were in remission (DAS 28 <2.6) and 143 (32.4%) were in low disease activity (LDA) state (DAS 28 <3.2). Thirty-one out of 73 (47.7%) patients, who were in remission at 10 weeks, maintained the state of remission at 54 weeks. On the other hand, 43 (11.7%) out of 394 patients, who were not in remission (DAS 28 ≥2.6) at 10 weeks, significantly improved and achieved remission at 54 weeks.
Conclusions The data from routine clinical practice in the Czech Republic confirms the expected efficacy of infliximab in the treatment of RA.The results of the treatment that were observed at 10 weeks had predictive value for the outcomes after the first year of therapy.
Acknowledgements The study was supported by grant MZ NT12437 from the Internal Grant Agency of the Ministry of Health of the Czech Republic.
Disclosure of Interest None Declared