SAT0406 Efficacy and Safety of Loxoprofen Hydrogel Patch versus Loxoprofen Tablet in Patients with Ankylosing Spondylitis: A Randomized Controlled Trial

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 patient9s 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.

References

Ward MM, Deodhar A, Akl EA, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis care & research 2015 doi: 10.1002/acr.22708 [published Online First: Epub Date]|. Mu R, Bao CD, Chen ZW, et al. Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial. Clinical rheumatology 2016;35(1):165–73 doi: 10.1007/s10067-014-2701-4 [published Online First: Epub Date]|. Singh G, Triadafilopoulos G. Epidemiology of NSAID induced gastrointestinal complications. The Journal of rheumatology Supplement 1999;56:18–24

Disclosure of Interest

None declared