Efficacy and tolerability of adalimumab (humira) in patients with active rheumatoid arthritis

Abstract

Objective: to evaluate the efficacy and tolerability of adalimumab alone and in combination with basic anti-inflammatory drugs (BAIDs) in patients with rheumatoid arthritis (RA), by taking into account the specific features of the course of the disease. Subjects and methods. The study enrolled 30 patients with a verified diagnosis of RA, its high activity by DAS 28, and ineffective previous therapy with standard BAIDs. At the beginning of the study, 20 (66.7%) patients continued taking BAIDs. According to therapy, the patients were divided into 3 groups: 1) 10 (33.3%) patients received subcutaneous adalimumab injections only; 2) 12 (40%) took adalimumab+methotrexate (MT); 3) 8 (26.7%) had adalimumab+leflunomide. The patient groups were matched for age, the duration and activity of RA (by DAS 28), its X-ray stage and seropositivity. Nine (37.5%) patients took oral glucocorticoids (GCs) and 25 (83.3%) received non-steroidal anti-inflammatory drugs (NSAIDs). Two (8.3%) patients had previously been prescribed biological therapies. Adalimumab was subcutaneously injected every 2 weeks for 24 weeks. The quantitative parameters of articular syndrome and blood and urine biochemical and clinical analyses were used to evaluate therapeutic effectiveness. The effect of therapy was evaluated by the ACR and EULAR (DAS 28) criteria. The efficiency of therapy was evaluated 12 and 24 weeks after therapy. Results. The clinical and laboratory effect of adalimumab was noted in 29 (96.7%) of the 30 patients. All the assessed parameters of articular syndrome became significantly lower (p<0.001) by week 12 of therapy and to a greater extent by week 24. Evaluation of the efficiency of adalimumab therapy by the ACR criteria showed that following 12-week therapy, the parameters were decreased by 20% in 87% of the patients and 50% in 16.7%; after 24 weeks, 23.3, 70 and 96.7% achieved very good (ACR 70), good (ACR 50), and satisfactory (ACR 20) effects. Estimation of the time course of changes in the disease activity index (DAS 28) revealed that adalimumab significantly reduced disease activity. Therapeutic effectiveness was also shown as reduced needs for NSAIDs and GCs. Positive clinical and laboratory changes during adalimumab+ MT combination therapy were also demonstrated to be significantly higher than those during adalimumab monotherapy or adalimumab + leflunomide combination therapy. Conclusion. Adalimumab is an effective disease-modifying biological agent. Its benefits may include the rapid development (on days 4-5 on average) and long retention (for 6 months or more) of an effect, a good safety profile (adverse reactions occurred only in 16.7% of the patients), and easiness-to-use.