gms | German Medical Science

Introduction: In the EXCEED head-to-head trial (NCT01752634), secukinumab (SEC) demonstrated higher simultaneous ACR50 plus PASI 100 response versus adalimumab (ADA) in patients (pts) with psoriatic arthritis (PsA) [1]. We report a post-hoc analysis that investigated efficacy across various PsA domains and composite indices in PsA pts who achieved ACR50 plus PASI 100 responses at Week (Wk) 52 in each treatment group.

Methods: Detailed study design and objectives have been reported previously [1]. A post-hoc analysis was performed to explore the efficacy of SEC and ADA on musculoskeletal outcomes, low disease activity (LDA), minimal disease activity (MDA) [2], PsA Disease Activity Score (PASDAS) LDA+Remission (REM), PASDAS REM [3], and very low disease activity (VLDA) in pts who achieved ACR50 plus PASI 100 response at Wk 52. Clinically meaningful improvement in physical function (HAQ-DI) and health-related quality of life (SF-36 PCS and DLQI) were also assessed. For binary endpoints, missing data were imputed as non-response at Wk 52 (non-responder imputation) and were not imputed for continuous endpoints (as observed).

Results: The combined endpoint of ACR50 plus PASI 100 response was achieved by 31% (66/215) of pts on SEC and 18% (37/202) on ADA at Wk 52. Efficacy across musculoskeletal outcomes, MDA response, PASDAS LDA+REM status, physical function (HAQ-DI) and HRQoL (SF-36 PCS and DLQI) was similar across both treatment groups (Table 1 [Tab. 1], Figure 1 [Fig. 1]). Over 80% of pts who achieved simultaneous ACR50 plus PASI 100 response also achieved MDA and PASDAS LDA+REM at Wk 52.

Conclusion: Most pts who simultaneously achieved ACR50 plus PASI 100 response with SEC or ADA developed similar responses across all other clinical PsA domains and achieved similar treat-to-target endpoints of MDA, VLDA and PASDAS LDA+REM and REM at Wk 52, as well as clinically meaningful improvements in function and HRQoL.

Disclosures: AG: Received honoraria as an advisory board member and consulting: Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb Co., Incyte, Janssen Inc. Leo Pharma, Eli Lilly, Novartis, Sun Pharmaceutical Industries, UCB, Xbiotech (only stock options which she has not used); and has received research/educational grants: Boehringer Ingelheim, Incyte, Janssen Inc., Novartis, UCB, Xbiotech, and Sun Pharma

PN: Funding for clinical trials and research and honoraria for advice and lectures on behalf of AbbVie, BMS, Pfizer, Lilly, Janssen, Celgene, Gilead/Galapagos, Novartis, MSD, Boehringer, Sanofi, Roche, Sandoz, Samsung, MSD

JG: Research grants, consultation fees, or speaker honoraria: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis and Pfizer

PG: Research grants, consultation fees, or speaker honoraria: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Janssen, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB

WB: Shareholder and Employee of Novartis

CG: Shareholder of Novartis and BMS and Employee of Novartis

LC: Grant/research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB and has received honoraria from AbbVie, Amgen, Boehringer-Ingelheim, Biogen, BMS, Celgene, Domain, Eli Lilly, Gilead, GSK, Janssen, Medac, Novartis, Pfizer, Serac and UCB