Clinical efficacy and safety of tocilizumab in the treatment of seropositive rheumatoid arthritis patients in India

Abstract

Background: Tocilizumab (TCZ) is a human interleukin (IL)-6 receptor (IL-6R) antibody which competitively inhibits IL-6 signal transduction. Clinical efficacy and safety of TCZ in the treatment of rheumatoid arthritis (RA) and other autoimmune conditions have been established. However, there is a lack of data on its use in the Indian population. Objective: The objective was to study the clinical efficacy and safety of TCZ in Indian patients with seropositive RA. Patients and Methods: This was a prospective, observational single-center study conducted at a tertiary care rheumatology center. All patients were more than 16 years of age, fulfilled the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA, and had at least moderate disease activity as measured by disease activity score-28 joints erythrocyte sedimentation rate (DAS28-ESR) ≥3.2 at enrollment while on at least two disease-modifying antirheumatic drugs. Patients with latent tuberculous infection were excluded from the study. Six doses of TCZ were administered at 8 mg/kg body weight dose at four weekly interval and clinical response was assessed at each visit. Results: All 30 patients enrolled completed the study. Baseline DAS28-ESR was 5.03 (SD0.39) which improved to 2.4 (△-2.6; 95% confidence interval: 2.30–3.04; P < 0.005) after 24 weeks. A total of 19 (63.3%) patients achieved remission (DAS-28 ESR < 2.6) at 24 weeks, while 25 (83.3%) patients showed a good EULAR response. No serious adverse effect was noted in any of the patients. Conclusions: TCZ is an effective and safe option for the treatment of seropositive RA.

Keywords

• biological disease-modifying antirheumatic drug
• il-6 receptor antagonist
• interleukin-6
• rheumatoid arthritis
• tocilizumab