Efficacy and safety of subcutaneous golimumab in Syrian patients with ankylosing spondylitis: A cohort study.

BackgroundAnkylosing spondylitis is a chronic inflammatory disease that causes severe spinal pain and structural disability. Conventional nonbiologic treatments often fail to provide adequate disease control.ObjectiveTo evaluate the 12 month clinical efficacy and safety of subcutaneous golimumab compared with those of other drug therapies in Syrian patients with active ankylosing spondylitis.MethodsThis prospective multicenter cohort study evaluated 66 patients with active ankylosing spondylitis who completed the 12-month observational period. Thirty-three (n = 33) patients received monthly subcutaneous golimumab from study initiation and 33 (n = 33) received other standard drug regimens (nonsteroidal anti-inflammatory drugs/conventional disease-modifying antirheumatic drugs). Disease activity and functional impairment were measured with Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores using area under the curve and longitudinal mean trends. Adverse events were monitored throughout the study period.ResultsPatients treated with golimumab from study initiation demonstrated a rapid, profound clinical response. Mean Bath Ankylosing Spondylitis Disease Activity Index scores decreased considerably from 6.93 to 1.22 at 12 months, resulting in the transition of 87.9% of the cohort into the "low disease activity" category. Similarly, mean Bath Ankylosing Spondylitis Functional Index scores decreased from 5.42 to 1.07, with no patient exhibiting functional impairment at 6 months. Conversely, the other drug arm exhibited gradual declines, with 60.6% of the patients remaining in the "severe functional impairment" category at 12 months. Area under the curve analysis revealed highly significant therapeutic superiority of golimumab for both parameters (p < 0.001). Golimumab was well tolerated with only mild, nonserious adverse event reported (upper respiratory infections, 6%), whereas patients in the other drug arm experienced peptic ulcers (6.1%) and elevated liver enzyme levels (3%).ConclusionIn a real-world clinical setting, initiating monthly subcutaneous golimumab achieved vastly superior 12-month efficacy and a favorable safety profile compared with other conventional drug regimens, rapidly reducing disease burden and restoring physical function in patients with active ankylosing spondylitis.