Background Guidelines for the treatment of spondyloarthritis with predominantly axial lesion (axSpA) consider non-steroid anti-inflammatory drugs (NSAIDs) as a first-line medication . However, currently unknown what scheme of NSAIDs administration in axSpA associated with optimal benefit/risk ratio.
Objectives is to evaluate the difference in short-term efficacy and safety of etoricoxib (ET) administered 7 or 3 times a week in patients with axSpA.
Methods 40 patients fulfilling ASAS criteria (16 non-radiographic axSpA/24 ankylosing spondylitis) with the Bath Ankylosing Spondylitis Index (BASDAI) ≥4 were randomized into 2 groups: 30 patients received 90 mg of ET per os every day (group 1), 10 patients received 90 mg of ET 3 times a week (group 2). The primary study endpoint was the percentage of patients who met ASAS40 (Assessment of Spondyloarthritis International Society 40) response criteria at week 12. Secondary endpoints included rates of a 50% BASDAI improvement (BASDAI50), ASAS20, ASAS partial remission, the AS disease activity score (ASDAS), clinically important and major improvements, ASDAS inactive disease, changes in the level of the C-reactive protein (CRP) up to week 12.
Results Groups 1 and 2 were matched in age, sex, disease activity. A significant reduction of BASDAI, ASDAS, CRP was observed at week 12 in both groups. Daily intake of ET was associated with greater reduction of activity compared with ET intake 3 times a week, table.
At week 12 in group 1 ASAS40 response was observed in 22 (73.3%) patients, ASAS20 response, ASAS partial remission and BASDAI50 response in 28 (93.3%), 7 (23.3%) and 11 (36.67%) patients, respectively. ASDAS clinically important improvement, ASDAS major improvements and ASDAS inactive disease state at week 12 were noted in 15 (50%), 6 (20%) and 4 (13.3%) patients, respectively. In group 2 at week 12 ASAS40 response was observed in 2 (20%) patients, ASAS20 response, ASAS partial remission and BASDAI50 response in 4 (40%), 1 (10%) and 3 (33.33%) patients, respectively. ASDAS clinically important improvement, ASDAS major improvements and ASDAS inactive disease states at week 12 were noted in 2 (20%), 1 (10%) and 0 (0%) patients, respectively. Totally, 5 adverse events (AE) occurred during the study (3 - in group 1 and 2 - in group 2). No serious AE were observed.
Conclusions Treatment outcomes are better in axSpA patients with daily intake of 90mg ET compared with administration of ET 3 times a week. No differences in safety of two treatment schemes were identified.
Braun J. Ann Rheum Dis. 2011; 70: 896–904.
Disclosure of Interest None declared