EFFECTIVENESS AND SAFETY PROFILE OF TNF ALPHA INHIBITORS IN REFRACTORY SPONDYLOARTHOPATHIES: AN OBSERVATIONAL STUDY.

Abstract

Background About 40% patients of Ankylosing Spondylitis (AS) are refractory to rst line therapy. This observational longitudinal study evaluated the effectiveness and safety of iniximab, a TNF alpha inhibitor in refractory AS in an Indian cohort. Methods Adult AS patients who were prescribed iniximab were enrolled. Clinical effectiveness was assessed by changes in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score from baseline to study end visit. Safety was assessed by observing the frequencies, type, severity and outcome of adverse drug reactions. Results 31 adult AS patients with mean age of 33.84 yr were enrolled. 67.74 % had >5 years disease duration. 29%, 42%, 26%, 3% received 1, 2, 3 and 4 doses of iniximab respectively. The BASDAI scores were signicantly reduced from baseline values in all patients (p<0.0001) and 55 % of the patients achieved >50% reduction of the baseline BASDI score at 6 months. 35% of the cohort reported at least one ADR and none were serious in nature. Conclusion Iniximab is an effective, safe biologic and provides a statistically as well as clinically signicant reduction in disease activity scores in refractory AS patients. A larger cohort size and longer follow up period shall provide further insights in this regard