Objectives: To assess the safety and efficacy of adalimumab for the treatment of active rheumatoid arthritis (RA).
Material and methods: 13 patients (10 females, 3 males) with established diagnosis of rheumatoid arthritis aged 31-67 years (mean age 51.2 years) entered the study. The inclusion criteria were high activity of the arthritis expressed by elevated ESR (>28 mm/h) and/or elevated CRP level (>1.5 mg/dl), swelling and tenderness of the peripheral joints, and inadequate response to disease-modifying anti-rheumatic drugs (DMARDs). Patients enrolled in the study received subcutaneous injections of adalimumab 40 mg every other week for 16 weeks. Prior to the study and at weeks 6 and 16 RA disease activity, tender and swollen joints count, duration of morning stiffness, quality of life (HAQ), ESR, CRP, peripheral blood morphology, and liver and kidney function were assessed. The occurrence of adverse events was noted.
Results: One patient (7.7%) terminated the study before week 16 due to miliary tuberculosis (the patient died in spite of adequate anti-tuberculosis treatment). Adverse events were reported in 2 (15.4%) patients: in one patient miliary tuberculosis was reported and in another one upper respiratory track infection and rash. 12 (92.3%) patients completed the study. At week 16 an ACR20 response was achieved by 66.7%, an ACR50 response by 33.3%, and an ACR70 response by 16.7% of patients with RA.
Conclusions: In this 16-week-long study adalimumab significantly reduced the symptoms and activity of the disease in patients with active RA, who previously inadequately responded to DMARDs.