Evaluation of the efficacy and safety of golimumab in patients with rheumatoid arthritis: A descriptive study

Abstract

Abstract Background: Rheumatoid arthritis is an autoimmune disease affecting the small joints in particular, leading to deformities which affects the quality of patient's life(1,2),so the treatment" goal is to achieve a state of clinical remission or, at least, low disease activity to prevent the progression of joint damage(3,4) Golimumab is an anti-TNF-alpha monoclonal antibody shows clinical efficacy in RA patients alone as a therapy, or with MTX, or after MTX failure, or after failure of at least one anti-TNF-alpha (8,10) and inhibition of the radiological progression of joint damage (11). Design: A Cross-Sectional Study conducted in Syria. Patients and methods: Subcutaneous golimumab 50mg once a month during 6 months was injected to Rheumatoid arthritis patients. The primary endpoint was the percentage of individuals with a good or moderate EULAR DAS28-ESR response after 6 months of treatment. Results: A total of 42 patients were included. Of these, 78.1% had very active disease (DAS28-ESR >5.4). 81.2% were taking methotrexate, 39.0% other DMARDs in monotherapy or combined, and 64.9% received corticosteroids (7, 5-15 mg/day). After 6 months, 82.7% of the patients showed a good or moderate EULAR response, 41.4% had low disease activity, and 29.1% were in remission. The percentage of responders one month after the first dose was 70.0%. The efficacy was similar in patients treated with methotrexate or other DMARDs, with different methotrexate doses, with or without corticosteroids, or in subjects who had failed one or more DMARDs. The response to golimumab was observed from the first dose. Golimumab was well tolerated and its safety profile was consistent with the findings of previous studies. Serious adverse events were reported in 3 patients (7.1%). Conclusion: RA patients treated with subcutaneous golimumab 50mg once a month to different DMARDs had achieved a moderate or good response after 6 months in 82.2% of the cases. The response was observed early, from the start of the second month, after a single dose of golimumab.