SAT0356 Discriminant Capacity of Clinical Efficacy Measures, Alone or in Combination with NSAID Intake, in Detecting Anti-TNF Treatment Effect in Spondyloarthritis: Table 1.
Authors: M. Dougados, E. Wood, L. Gossec, D. van der Heijde, A. Dubanchet, I. Logeart
Journal: Annals of the Rheumatic Diseases (2014)

<h3>Background</h3> In placebo (PBO)-controlled trials of anti-TNF therapy in spondyloarthritis (SpA), background NSAIDs are maintained at stable levels to facilitate demonstration of the anti-TNF treatment effect. In daily practice, most patients (pts) receive NSAIDs on demand and reduce/stop their NSAID intake as soon as the anti-TNF agent is effective. <h3>Objectives</h3> To compare the capacity of conventional clinical outcome measures and changes in NSAID therapy alone vs in combination to discriminate between treatment effects at 8 weeks. <h3>Methods</h3> In a prospective, randomized, PBO-controlled trial (SPARSE), the NSAID-sparing effect of etanercept (ETN) was evaluated in pts with active axial SpA (axSpA). NSAID intake was evaluated using the ASAS-NSAID equivalent score.<sup>1</sup> Post hoc logistic regression analyses were performed at week 8 for single conventional clinical measures: BASDAI50, BASDAI ≤3, ASAS20 and ASAS40, ASDAS remission, and ASDAS LDAS; single NSAID intake measures: decrease ≥50%, score &lt;10, and score=0; and each clinical measure in combination (AND/OR) with each NSAID measure. No adjustments were made for multiple comparisons. <h3>Results</h3> In 90 randomized pts, mean (±SD) NSAID score (ETN vs PBO, 98.2±39.0 vs 93.0±23.4), ASDAS-CRP (3.4±0.9 vs 3.2±0.8), and BASDAI (6.0±1.6 vs 5.9±1.5) were similar between groups at baseline (BL). Observed treatment effects for clinical and NSAID score measures alone and combined ranged from an odds ratio (OR) of 1.6 (95% CI 0.5-5.4; <i>P</i>=0.42) for ASDAS remission alone to 6.4 (95% CI 2.2-19.2; <i>P</i>=0.0008) for [ASDAS LDAS OR NSAID score decrease ≥50%], with most measures reaching statistical significance (α=0.05), in favor of ETN (32 of 45). Most combined outcome variables using "OR" were more discriminant than single outcome measures (see ASAS20 in table). <h3>Conclusions</h3> This study suggests that 1) potential changes in NSAID intake during treatment do not prevent demonstration of a clinically relevant anti-TNF treatment effect; and 2) combined (ie, clinical+NSAID-sparing) outcome variables were at least as discriminant as single (ie, clinical) outcome variables. Such results may impact future clinical trial design. <h3>References</h3> Dougados M, et al. Ann Rheum Dis 2011;70(2):249-51. <h3>Acknowledgements</h3> This study was sponsored by Pfizer Inc. Medical writing support was provided by Donna McGuire of Engage Scientific and was funded by Pfizer Inc. <h3>Disclosure of Interest</h3> M. Dougados Grant/research support: AbbVie, Celgene, Eli Lilly, Novartis, Pfizer, Roche, and Sanofi-Aventis., Consultant for: AbbVie, Celgene, Eli Lilly, Novartis, Pfizer, Roche, and Sanofi-Aventis., E. Wood Consultant for: Full-time employee of Quanticate International, contracted by Pfizer Inc. to provide statistical input to the study and manuscript., L. Gossec Consultant for: AbbVie, Janssen, Pfizer, Roche and UCB., D. van der Heijde Grant/research support: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, Chugai, Daiichi, Eli Lilly, GlaxoSmithKline, Janssen Biologics, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, and Vertex., Consultant for: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, Chugai, Daiichi, Eli Lilly, GlaxoSmithKline, Janssen Biologics, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, and Vertex., Employee of: Director of Imaging Rheumatology bv., A. Dubanchet Shareholder of: Pfizer., Employee of: Pfizer., I. Logeart Shareholder of: Pfizer., Employee of: Pfizer. <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.1469