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dc.contributor.authorWright, Grace
dc.contributor.authorNash, Peter
dc.contributor.authorCoates, Laura
dc.contributor.authorGratacos, Jordi
dc.contributor.authorBehrens, Frank
dc.contributor.authorDing, Kevin
dc.contributor.authorBao, Weibin
dc.contributor.authorPricop, Luminita
dc.contributor.authorGaillez, Corine
dc.contributor.authorMcInnes, Iain
dc.date.accessioned2021-04-13T00:16:08Z
dc.date.available2021-04-13T00:16:08Z
dc.date.issued2020
dc.identifier.issn2326-5191
dc.identifier.urihttp://hdl.handle.net/10072/403658
dc.description.abstractBackground/Purpose: Lower effi cacy to anti-tumor necrosis factor treatment has been reported in female patients with psoriatic arthritis (PsA) as compared to males in clinical registries. 1 The EXCEED study (NCT02745080) evaluated effi cacy and safety of secukinumab (SEC) versus adalimumab (ADA) as fi rst-line monotherapy in biologic-naïve patients with PsA. Here, we report the impact of sex on effi cacy outcomes with SEC versus ADA at Week 52 from the EXCEED study. Methods: Eligible patients were randomized 1:1 to receive SEC 300 mg subcutaneous at baseline, Week 1-4, followed by dosing every 4 weeks until Week 48 or ADA 40 mg subcutaneous at baseline followed by same dosing every 2 weeks until Week 50. The detailed study design and objectives have been previously described. 2 The primary analysis was to demonstrate superiority of SEC versus ADA on ACR20 response at Week 52 using logistic regression model with treatment as a factor and baseline weight as a covariate. A post-hoc analysis for ACR20 response was performed using the same model with treatment, sex and smoking status as factors to adjust for imbalances observed in the baseline characteristics. Comparative post - hoc analysis was performed with SEC versus ADA by sex for other effi cacy outcomes through Week 52. Results: A total of 853 patients were randomized to receive SEC (N=426) or ADA (N=427) with similar baseline demographics except for higher proportion of females (51% in SEC; 46% in ADA) and smokers (21·8% in SEC; 17·8% in ADA) in the SEC group. 2 The primary endpoint for ACR20 response at Week 52 was not met. ACR20 response at Week 52 was, SEC (67·4%) versus ADA (61·4%); p=0·0227, after adjusting for sex and smoking status. The female patients had higher tender joint count, patient global assessment, HAQ-DI, PsA pain and enthesitis compared to males ( Table 1 ). A greater proportion of patients with SEC (83·0% females; 91·3% males) completed Week 52 versus ADA (74·2% females; 83·4% males). SEC was associated with numerically higher effi cacy on joints in females at Week 52 without any notable differences in the ACR core components versus ADA. Overall, higher effi cacy was demonstrated in males versus females at Week 52 ( Table 2 ). Conclusion: Females had greater baseline disease severity than males. Secukinumab was associated with higher retention rate in both males and females at Week 52. Secukinumab provided numerically higher clinical responses in females versus adalimumab in musculoskeletal and skin endpoints and physical function at Week 52. In males, similar effi cacy on musculoskeletal endpoints for both treatments and greater effi cacy on skin with secukinumab were observed. These interesting fi ndings warrant further investigation for reproducibility or uniqueness.
dc.languageEnglish
dc.publisherWiley
dc.publisher.urihttps://onlinelibrary.wiley.com/doi/10.1002/art.41538
dc.relation.ispartofconferencenameACR Convergence 2020
dc.relation.ispartofconferencetitleArthritis & Rheumatology
dc.relation.ispartofdatefrom2020-11-05
dc.relation.ispartofdateto2020-11-09
dc.relation.ispartoflocationVirtual
dc.relation.ispartofpagefrom1032
dc.relation.ispartofpageto1034
dc.relation.ispartofissueS10
dc.relation.ispartofvolume72
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchcode3202
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.subject.keywordsRheumatology
dc.titleComparison of Secukinumab versus Adalimumab Efficacy by Sex in Psoriatic Arthritis from a Phase 3b, Double-blinded, Randomized, Active-controlled Study
dc.typeConference output
dc.type.descriptionE3 - Conferences (Extract Paper)
dcterms.bibliographicCitationWright, G; Nash, P; Coates, L; Gratacos, J; Behrens, F; Ding, K; Bao, W; Pricop, L; Gaillez, C; McInnes, I, Comparison of Secukinumab versus Adalimumab Efficacy by Sex in Psoriatic Arthritis from a Phase 3b, Double-blinded, Randomized, Active-controlled Study, Arthritis & Rheumatology, 2020, 72 (S10), pp. 1032-1034
dc.date.updated2021-04-12T00:21:24Z
gro.hasfulltextNo Full Text
gro.griffith.authorNash, Peter


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