Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh.

BACKGROUND

The present study aimed to determine the efficacy and safety of thalidomide compared to sulfasalazine (SSZ) in moderate to severe cases of ankylosing spondylitis (AS) in Bangladesh.

METHODS

This experimental study was conducted from January 2017 to December 2018 in the Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh. The experimental study included 93 adult patients with moderate to severe AS (47 received thalidomide, and 46 received SSZ). Change in disease status was considered an efficacy endpoint, while the prevalence of adverse events was considered a safety endpoint.

RESULTS

Thalidomide showed better efficacy compared to SSZ in terms of disease activity index (Bath Ankylosing Spondylitis Disease Activity Index) (2.84 vs. 4.49, p < 0.001). Secondary endpoints such as functional index (Bath Ankylosing Spondylitis Functional Index) (2.32 vs. 3.34, p = 0.021), patients' global assessment (2.92 vs. 4.11, p < 0.001), physician global assessment (2.67 vs. 3.60, p < 0.001), spinal pain score (2.52 vs. 3.31, p = 0.025), swollen joint count (0.05 vs. 0.40, p < 0.001), morning stiffness (2.08 vs. 3.27, p < 0.001), erythrocyte sedimentation rate (28.17 mm vs. 34.25 mm, p = 0.023), and C-reactive protein (9.57 mg/l vs. 21.34 mg/l, p = 0.027) were also better in the thalidomide group. Moreover, a significantly higher number of patients achieved 40% improvement in the thalidomide group compared to the SSZ group (90% vs. 10%, p < 0.001). Pedal edema was the most common adverse event (16, 46%) in the thalidomide group, followed by somnolence (13, 37%), drowsiness (12, 34%), dry mouth (11, 31%), and skin rash (11, 31%). On the other hand, anorexia (17, 48%), headache (15, 43%), and gastric irritation (10, 28%) were common adverse events in the SSZ group.

CONCLUSION

Despite a few mild side effects, thalidomide is effective and safe in comparison with SSZ for treating patients with moderate to severe AS for short-term assessment.