Desirable and Adverse Effects
Results of a study of sirukumab – a new drug for treatment of rheumatoid arthritis by Johnson & Johnson and GlaxoSmithKline were presented at the annual meeting of the European League Against Rheumatism (EULAR).
Sirukumab, an anti IL-6 monoclonal antibody selectively inhibiting interleukin-6 — is a cytokine, playing a key role in the process of inflamation.
Results of clinical trials presented to the collection of members of the European antirheumatic league were quite convincing. The studies included 1870 patients who received injections of the drug. In Group one sikurumab 50 mg was administered every four weeks, in group two sirukumab 100 mg was administered every two weeks, group three received placebo.
At the EULAR meeting it was reported that treatment with investigational drug for 16 weeks led to a 20 per cent improvement of symptoms in 53,5% — 54,8% patients (100 mg and 50 mg, respectively). In the placebo group the improvement rate was 26.4%. Improvement of symptoms of rheumatoid arthritis by 50% was reported in 30% of patients receiving sirukumab and in 12% of patients in the reference group.
At the same time, an X-ray examination of patients has shown that the severity of lesions in the sirukumab group was significantly less pronounced than in the placebo group.
However, the rate of serious adverse effects in patients who received the investigational drug, was significantly higher. 9,8-11% patients in the sirukumab group reported adverse reactions to therapy, while just 6.8% patients in the placebo group reported adverse effects.