Evaluation of the efficacy of etoricoxib in ankylosing spondylitis: results of a fifty-two-week, randomized, controlled study. Longitudinal Numbers-Needed-To-Treat (NNT) for Achieving Various Levels of Analgesic Response and Improvement with Etoricoxib, Naproxen, and Placebo in Ankylosing Spondylitis MRI and clinical findings in patients with ankylosing spondylitis eligible for anti-tumour necrosis factor therapy after a short course of etoricoxib Etoricoxib in ankylosing spondylitis: is there a role for active patients refractory to traditional NSAIDs? Efficacy of cyclo-oxygenase-2 inhibition by etoricoxib and naproxen on the axial manifestations of ankylosing spondylitis in the presence of peripheral arthritis
OBJECTIVE To assess the efficacy , safety , and tolerability of etoricoxib , a cyclooxygenase 2 ( COX-2 ) selective inhibitor , administered continuously over 52 weeks for the treatment of ankylosing spondylitis ( AS ) . METHODS This 2-part , multicenter , double-blind , parallel-group , 52-week study evaluated 2 doses of etoricoxib ( 90 and 120 mg ) compared with naproxen at 1,000 mg . A 6-week , active-comparator- and placebo-controlled period ( part I ) was followed by a 46-week active-comparator-controlled period ( part II ) . The primary outcome measures ( on 100-mm visual analog scales ) were patient 's assessment of spine pain , patient 's global assessment of disease activity , and the Bath Ankylosing Spondylitis Functional Index . RESULTS Of the 387 patients r and omized to receive treatment , 301 ( 77.8 % ) completed part I and 284 ( 75.9 % ) completed part II . Compared with placebo over 6 weeks , those receiving 90 mg etoricoxib , 120 mg etoricoxib , and naproxen demonstrated significantly ( P < 0.001 ) greater improvement in all primary end points ; treatment effects ( expressed as the difference in least squares mean change versus placebo ) were 21 - 29 mm for spine pain , 18 - 25 mm for disease activity , and 11 - 15 mm for function . Compared with patients receiving naproxen , significantly greater improvement in all primary end points was demonstrated in the combined group receiving either 90 mg etoricoxib or 120 mg etoricoxib over 6 weeks , in each individual etoricoxib treatment group over 6 weeks , and in the combined etoricoxib group over 1 year ( all P < 0.05 ) ; results for secondary and exploratory end points were generally consistent with those from the primary analysis . Among all groups , there were no significant differences in the incidence of overall clinical , drug-related , or serious adverse experiences ( AEs ) and discontinuations due to AEs . Safety observations during part II were generally consistent with those in part I. CONCLUSION Etoricoxib at doses of 90 mg and 120 mg demonstrated superior efficacy compared with placebo over 6 weeks , and compared with naproxen over 1 year . These study results demonstrate that etoricoxib is generally safe , well-tolerated , and efficacious for the treatment of AS Background Clinical analgesic trials typically report response as group mean results . However , research has shown that few patients are average and most have responses at the extremes . Moreover , group mean results do not convey response levels and thus have limited value in representing the benefit-risk at an individual level . Responder analyses and numbers-needed-to-treat ( NNT ) are considered more relevant for evaluating treatment response . We evaluated levels of analgesic response and Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) score improvement and the associated NNTs . Methods This was a post-hoc analysis of a 6-week , r and omized , double-blind study ( N = 387 ) comparing etoricoxib 90 mg , etoricoxib 120 mg , naproxen 1000 mg , and placebo in AS . Spine pain and BASDAI were measured on a 100-mm visual analog scale . The number and percentage of patients achieving ≥30 % and ≥50 % improvement in both BASDAI and spine pain were calculated and used to determine the corresponding NNTs . Patients who discontinued from the study for any reason were assigned zero improvement beyond 7 days of the time of discontinuation . Results For etoricoxib 90 mg , etoricoxib 120 mg and naproxen 1000 mg , the NNTs at 6 weeks compared with placebo were 2.0 , 2.0 , and 2.7 respectively for BASDAI ≥30 % improvement , and 3.2 , 2.8 , and 4.1 for ≥50 % improvement . For spine pain , the NNTs were 1.9 , 2.0 , and 3.2 , respectively , for ≥30 % improvement , and 2.7 , 2.5 , and 3.7 for ≥50 % improvement . The differences between etoricoxib and naproxen exceeded the limit of ±0.5 units described as a clinical ly meaningful difference for pain . Response rates and NNTs were generally similar and stable over 2 , 4 , and 6 weeks . Conclusions For every 2 patients treated with etoricoxib , 1 achieved a clinical ly meaningful ( ≥30 % ) improvement in spine pain and BASDAI beyond that expected from placebo , whereas the corresponding values were approximately 1 in every 3 patients treated with naproxen . Use of NNTs and responder analyses provide additional , complementary information beyond population mean responses when assessing efficacy compared to placebo and amongst active therapies Objective : To describe and assess the response to short-term etoricoxib as shown by MRI and clinical variables in patients with ankylosing spondylitis ( AS ) selected for eligibility for anti-tumour necrosis factor therapy .  Methods : In a 6-week open-label study , 22 patients with AS and eligible for biological therapy were treated with 90 mg of etoricoxib daily . Clinical and laboratory parameters were obtained and MRI of the sacroiliac joints and the lower thoracic and lumbar spine performed at baseline and at week 6 . The primary end point was the proportion of patients fulfilling the SpondyloArthritis international Society ( ASAS ) response criteria for biological therapies ( ASASBIO ) while secondary end points included the change in MRI-determined bone lesions . Results : Eight of 20 completers improved enough to meet the ASASBIO response criteria and most clinical variables improved significantly . Fifteen patients had a total of 63 MRI-detectable lesions ; overall , 13/60 lesions with paired scans either resolved completely or improved , while five lesions worsened or appeared during treatment . Conclusion : Etoricoxib is an effective symptomatic treatment for patients with AS ; however , its effect on MRI-detected lesions is small . Further studies are needed to determine the effect of etoricoxib on MRI-determined bone oedema 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 , r and omised , prospect i ve ( 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 Objective : The combined efficacy of selective and non-selective cyclo-oxygenase-2 ( COX-2 ) inhibition on the axial manifestations of ankylosing spondylitis ( AS ) in the presence or absence of chronic peripheral arthritis was evaluated . Methods : In a post hoc subgroup analysis of a 6 week , r and omised , double blind , placebo controlled trial , 387 patients with active axial AS were r and omised to receive etoricoxib 90 mg or 120 mg once a day , naproxen 500 mg twice daily , or placebo . R and omisation was stratified by the presence or absence of chronic peripheral arthritis . The primary outcome measure was the time weighted average change from baseline of spine pain intensity . Efficacy data from the three groups receiving active treatment ( the NSAID/COX-2 inhibitor group ) were combined to improve precision . An analysis of covariance model was used to evaluate the effect of peripheral disease on treatment response . Results : 93 patients were allocated to receive placebo and 294 to active treatment ( naproxen or etoricoxib ) . The combined NSAID/COX-2 inhibitor group had a significant treatment response compared with the placebo group for all efficacy measures , both in patients with and without peripheral arthritis . A significantly greater difference in mean patient assessment of spine pain was found between active and placebo treatments in patients without compared with those with peripheral arthritis ( p = 0.005 ; −32.5 mm v −17.0 mm , respectively ) . Similar differences , although not statistically significant , were seen for other end points . Conclusion : NSAIDs and COX-2 inhibitors have a clinical ly relevant symptomatic effect on axial AS irrespective of the presence of peripheral arthritis . In this exploratory analysis spinal improvement appeared to be greater in patients without peripheral disease
Results : This systematic review will provide a detailed summary of present evidence related to the efficacy and safety  of etoricoxib for patients with AS .
Conclusion : The results of this study may provide management guidance for AS treated by etoricoxib .
Background : Previous clinical trials have reported that etoricoxib has been utilized to treat ankylosing spondylitis ( AS ) effectively .
However , no study systematic ally investigated the efficacy and safety of etoricoxib for patients with AS .
In this systematic review , we will assess the efficacy and safety of etoricoxib for AS .