Background Non-steroidal anti-inflammatory drugs (NSAIDs) are the cornerstone of medication for patients with ankylosing spondylitis (AS). However, oral NSAIDs are associated with adverse events such as gastrointestinal, cardiovascular and renal events.
Objectives To assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in the treatment of active AS.
Methods The study population consisted of patients who met the modified New York radiographic criteria for AS and had to be active disease, defined by the Bath AS Disease Activity Index (BASDAI) ≥4 or the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level (ASDAS-CRP) ≥1.3. Patients were randomly assigned to either the LX-P group or the LX-T group for 4 weeks. The primary efficacy endpoint was the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20) at week 4. Secondary efficacy outcomes included mean changes from baseline to week 4 for ASDAS-CRP, BASDAI and patient's global assessment of disease activity (PTGA). Adverse events were monitored throughout the study.
Results Of 70 randomized patients, 35 patients were allocated to the LX-P group and 35 to the LX-T group. In the intent-to-treat population, no significant differences were found between the two groups in the proportion of patients achieving ASAS20 response at week 4 (19 of 35 [54.3%] for LX-P group versus 26 of 35 [74.3%] for LX-T group; P=0.081). And there were no significant differences for the mean change of ASDAS-CRP, BASDAI and PTGA from baseline to week 4 between LX-P and LX-T group. Post hoc analyses suggested that patients without peripheral arthritis in the LX-P group were more likely to achieve ASAS20 response than those with peripheral arthritis. A lower incidence of gastrointestinal disorders was observed in LX-P group. No serious adverse events were reported in the two groups.
Conclusions LX-P is noninferior to LX-T for improvement of disease activity in patients with active AS, and has few gastrointestinal adverse events.
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Disclosure of Interest None declared