Baseline Disease Activity As A Predictor For Achieving Cdapsa Treatment Targets With Apremilast In Dmard-Naive Patients With Manifestations Of Active Psoriatic Arthritis

Background:In PALACE 4, DMARD-naive patients (pts) with moderately active (ModDA) psoriatic arthritis (PsA) at baseline (BL) were more likely to achieve Clinical Disease Activity Index for PsA (cDAPSA) treatment targets (cDAPSA remission [REM] or low disease activity [LDA]) at Week 52 with continued apremilast 30 mg BID (APR) treatment than pts with high disease activity (HDA) at BL. Pts who achieved cDAPSA treatment targets also had no or mild articular and extra-articular disease activity by Week 52. Whether specific PsA manifestations other than arthritis impact the achievement of cDAPSA treatment targets in this population is unknown.Objectives:To assess the predictive value of BL clinical disease status on achieving cDAPSA treatment targets in DMARD-naive pts in PALACE 4 with PsA in ModDA or HDA who exhibited manifestations of skin involvement, enthesitis, and/or dactylitis at BL.Methods:This post hoc analysis included APR-treated pts in ModDA or HDA with available cDAPSA data at BL and Week 52 who exhibited any of the PsA manifestations at BL, including skin-involved body surface area (BSA) ≥3%, Maastricht Ankylosing Spondylitis Entheses Score (MASES) >0, or dactylitis count >0. Pts were divided into 4 subgroups based on number of manifestations: ≥1, only 1, any 2, or all 3. The proportions of pts who shifted across ModDA (>13 to ≤27) and HDA (>27) cDAPSA categories at BL to REM (≤4) and LDA (>4 to ≤13) treatment targets at Week 52 were calculated (data as observed).Results:In 176 PALACE 4 pts with PsA receiving APR, 165 had involvement in ≥1 PsA manifestation in addition to peripheral arthritis (ie, skin/enthesitis/dactylitis) at BL. This population had a mean age of 48.8 years, PsA duration of 3.6 years, Psoriasis Area and Severity Index (PASI) score of 6.6, MASES of 3.8, and dactylitis count of 3.5 (Table 1). Within this subgroup, 32.7% had only 1 of these non-arthritic PsA manifestations, 50.9% had any 2, and 16.4% had all 3. In pts with ≥1 manifestation, a greater proportion in ModDA achieved REM/LDA at Week 52 than those in HDA (66.7% vs 32.2%; risk difference: 0.34) (Figure 1). Similarly, greater rates of treatment target achievement were observed in subgroups of pts in ModDA vs HDA and only 1 (72.2% vs 39.1%; risk difference: 0.33), any 2 (57.1% vs 28.6%; risk difference: 0.29), or all 3 (75.0% vs 33.3%; risk difference: 0.42) PsA manifestations (Figure 1).Conclusion:In DMARD-naive pts exhibiting various non-arthritic manifestations of active PsA (ie, skin/enthesitis/dactylitis), those in ModDA at BL were more likely to achieve cDAPSA REM or LDA at Week 52 of APR treatment than pts in HDA. This observation was consistent whether pts had only 1 or multiple manifestations. These findings are consistent with the probability of achieving treatment targets demonstrated in the overall population in PALACE 4 (61.7% ModDA vs 28.2% HDA).Table 1.BL Demographics and Disease Characteristics in Pts With ≥1 Manifestations of PsA (Skin Involvement, Enthesitis, and/or Dactylitis) Treated With APR (N = 165)Age*, years48.8 (12.5)Women, n (%)87 (52.7)BMI*, kg/m229.9 (6.5)Duration of PsA*, years3.6 (5.0)Duration of psoriasis*, years15.5 (13.3)cDAPSA (0-154)*39.4 (19.7)Swollen joint count (0-66)*10.3 (7.7)Tender joint count (0-68)*18.5 (12.9)Pt’s Assessment of Pain (VAS 0-100 mm)*52.8 (21.5)Pt’s Global Assessment (VAS 0-100 mm)*53.8 (20.1)Physician’s Global Assessment (VAS 0-100 mm)*52.2 (17.6)PASI score (0-72)*,†6.6 (5.1)MASES (0-13)*,‡3.8 (3.0)Dactylitis count (0-20)*,§3.5 (3.3)Corticosteroid use, n (%)13 (7.9)NSAID use, n (%)126 (76.4)*Mean (SD).†In pts with BSA ≥3% at BL.‡In pts with enthesitis at BL.§In pts with dactylitis at BL.Acknowledgements:This study was funded by Celgene. Additional analyses were funded by Amgen Inc. Writing support was funded by Amgen Inc. and provided by Kristin Carlin, RPh, MBA, of Peloton Advantage, LLC, an OPEN Health company.Figure 1.Disclosure of Interests:Philip J Mease Speakers bureau: AbbVie, Amgen Inc., Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen Inc., Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, GSK, Novartis, Pfizer, Sun, and UCB, Grant/research support from: AbbVie, Amgen Inc., Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, GSK, Novartis, Pfizer, Sun, and UCB, Arthur Kavanaugh Grant/research support from: AbbVie, Amgen Inc., AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB, Alexis Ogdie Consultant of: AbbVie, Amgen Inc., BMS, Celgene, Corrona, Eli Lilly, Gilead, Novartis, Pfizer, and UCB, Grant/research support from: Novartis and Pfizer, Alvin F. Wells Speakers bureau: AbbVie, Alexion, Amgen Inc., BMS, Celgene, Horizon, Lilly, Novartis, and UCB, Consultant of: AbbVie, Alexion, Amgen Inc., BMS, Celgene, Horizon, Lilly, Novartis, and UCB, Grant/research support from: AbbVie, Celgene, and Lilly, Martin Bergman Shareholder of: Johnson & Johnson, Speakers bureau: AbbVie, Amgen Inc., Novartis, Pfizer, and Sanofi, Consultant of: AbbVie, BMS, Celgene, Genentech, Janssen, Merck, Novartis, Pfizer, and Sanofi, Dafna D Gladman Consultant of: AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB, Frank Behrens Speakers bureau: AbbVie, Biotest, Boehringer Ingelheim, Celgene, Chugai, Eli Lilly, Genzyme, Janssen, Novartis, Pfizer, Roche, and UCB, Grant/research support from: AbbVie, Chugai, Janssen, Roche, and Pfizer, Yuri Klyachkin Employee of: Amgen Inc., Sven Richter Employee of: Amgen Inc., Lichen Teng Employee of: Amgen Inc., Josef S. Smolen Speakers bureau: AbbVie, Amgen Inc., AstraZeneca, Astro, Celgene, Celtrion, Eli Lilly, Glaxo, ILTOO, Janssen, Medimmune, MSD, Novartis, Pfizer, Roche, Samsung, Sanofi, and UCB, Consultant of: AbbVie, Amgen Inc., AstraZeneca, Astro, Celgene, Celtrion, Eli Lilly, Glaxo, ILTOO, Janssen, Medimmune, MSD, Novartis, Pfizer, Roche, Samsung, Sanofi, and UCB, Grant/research support from: AbbVie, Eli Lilly, Janssen, MSD, Medimmune, Pfizer, and Roche.