Background Evaluation of the efficacy and safety of the chimeric anti tumour nekrosis factor alpha (TNFa) antibody Infliximab in therapy resistant rheumatoid arthritis (RA).
Methods 22 patients (mean age 59 years, mean duration of disease 9,5 years) with active RA, according to the ACR criteria, which were therapy resistant to two and more disease modifying antirheumatic drugs (DMARDs), including MTX, received 3 infusions of 3 mg/kg Infliximab at week 0, 2 and 6. Nine patients have been observed over a period of 30 weeks (0, 2, 6, 14, 22, 30). Standard clinical and laboratory assessments, including swollen joint count (SJC), tender joint count (TJC), morning stiffness (MST), visual analogue scale of patient pain assessment (VAS), C- reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were evaluated at baseline and at any time of drug administration.
Results After 3 infusions 65% of the patients achieved an 20% response (ACR 20). All clinical and laboratory assessments showed a significant improvement [SJC 10,2 before (B) vs.3,2 after 3 infusions (A), p = 0,001, TJC 26,6 (B) vs.9,1 (A), p = 0,001, MST 101,2 min (B) vs. 36,8 min (A), p = 0,002, CRP 26,9 mg/dl (B) vs. 17 mg/dl (A), p = 0,015, ESR 56,6 mm (B) vs. 31,2 mm (A), p = 0,001, VAS 7,4 (B) vs. 4,1 (A)]. Only mild adverse events but no severe infections occurred in the observation period.
After 30 weeks 44% maintained an ACR 20 response. A sustained improvement of clinical and laboratory assessments was observed.
Conclusion Infliximab seems to be an effective and safe treatment of therapy resistant active RA with a sustained improvement in clinical and laboratory assessments over a period of 30 weeks.