Objectives: To evaluate the efficacy of etoricoxib in patients with axial ankylosing spondyloarthritis (AS) refractory to traditional NSAIDs.
Methods: This was an open label, multicentric, randomised, prospective (4 weeks with and open extension to 6 months), non-controlled study. Consecutive patients with axial AS refractory to traditional NSAID eligible for anti-TNF-α therapy were selected. The primary outcomes were the rate of patients with good clinical response (not eligible for anti-TNF-α therapy after etoricoxib) and the Assessment of Spondyloarthritis International Society response criteria for biologic therapies (ASASBIO) response at 4 weeks. Secondary outcomes included: ASAS20 and 40 responses, ASDAS-CRP response, BASDAI, BASFI, back and night back pain, global patient and physician assessment of the disease, and biologic parameters like C-reactive protein (CRP) at 2, 4 weeks and 6 months.
Results: A total of 57 axial AS patients were recruited, 46 men, with mean age of 43 years. After 4 weeks of treatment, 26 patients (46%) achieved a good clinical response and 11 (20%) an ASASBIO response. These results at 24 weeks were 19 (33%) and 13 (23%) respectively. All individual clinical variables improved significantly after 4 weeks of treatment. CRP serum levels decreased after 4 weeks but reached no statistical significance, although 30% of patients showed a normalisation of CRP.
Conclusions: Etoricoxib provided a clear clinical improvement in around a third of patients with axial AS refractory to traditional NSAIDs. Special care should be required when deciding to start anti-TNF-α therapy; it seems reasonable to keep in mind these results of etoricoxib treatment.