AB0552 PROBABILITY OF ACHIEVING TREATMENT TARGETS WITH APREMILAST MONOTHERAPY IN BIOLOGIC-NAIVE PSORIATIC ARTHRITIS PATIENTS IN ACTIVE WITH MODERATE AND HIGH BASELINE DISEASE ACTIVITY

Abstract

Background:Patients with psoriatic arthritis (PsA) in moderate disease activity (ModDA) who are naive to disease-modifying antirheumatic drugs (DMARDs) have a higher probability of achieving the Clinical Disease Activity Index for PsA (cDAPSA) treatment targets after receiving apremilast 30 mg BID (APR) than those in high disease activity (HDA). In Europe, APR is indicated for the treatment of active PsA in adult patients who had an inadequate response or were intolerant to a prior DMARD therapy. Achievement of cDAPSA treatment targets with APR monotherapy in biologic-naive patients with PsA who had previously taken a maximum of 1 conventional synthetic DMARD (csDMARD) has not been evaluated.Objectives:To assess the predictive value of baseline clinical disease status on achieving long-term cDAPSA treatment targets at Week 52 among biologic-naive patients with PsA in the phase 3b, randomized, placebo-controlled Assessing Apremilast Monotherapy in a Clinical Trial of Biologic-Naive Patients With PsA (ACTIVE).Methods:ACTIVE enrolled adults with PsA who had ≥3 swollen and ≥3 tender joints and were biologic naive with prior failure of a maximum of 1 csDMARD. In this post hoc analysis, we assessed the probabilities of achieving cDAPSA treatment targets of remission (REM; ≤4) or low disease activity (LDA; >4 to ≤13) at Week 52 in patients randomized to APR and stratified by cDAPSA ModDA (>13 to ≤27) or HDA (>27) at baseline. Patients with enthesitis at baseline in each stratum were analyzed separately.Results:Of the 109 patients randomized to APR, 35 were in ModDA (32.1%) and 71 were in HDA (65.1%) at baseline (Table 1). For patients with ModDA vs HDA at baseline, swollen (4.6 vs 10.8) and tender (6.7 vs 21.7) joint counts were lower, and the prevalence of enthesitis was lower (42.9% vs 57.7%) (Table 1). Patients in ModDA at baseline were estimated to be more than twice as likely to achieve treatment targets at Week 52 vs patients in HDA at baseline (Figure 1). Consistent with these results, a higher proportion of patients with ModDA + enthesitis at baseline achieved treatment targets at Week 52 than patients with HDA + enthesitis at baseline (58.9% vs 32.8%).Table 1.Baseline Demographics and Disease CharacteristicsBaseline cDAPSA CategoryModDA (n = 35)HDA (n = 71)Age, mean (SD), years48.5 (12.9)51.6 (11.8)Women, n (%)20 (57.1)36 (50.7)White, n (%)34 (97.1)71 (100.0)PsA duration, mean (SD), years4.5 (4.6)3.8 (4.5)Enthesitis, n (%)15 (42.9)41 (57.7)SJC (0-66), mean (SD)4.6 (1.6)10.8 (4.3)TJC (0-68), mean (SD)6.7 (2.2)21.7 (11.5)PtGA (0-10 NRS), mean (SD)4.9 (1.4)6.5 (2.0)PhGA (0-10 NRS), mean (SD)5.4 (1.2)6.6 (1.5)The n represents the total sample. The number of patients with data available may vary. Not included are 3 patients in LDA at baseline. NRS = Numeric Rating Scale; PhGA = Physician’s Global Assessment of Disease Activity; PtGA = Patient’s Global Assessment of Disease Activity; SJC = swollen joint count; TJC = tender joint count.Figure 1.Conclusion:Similar to observations in DMARD-naive patients with PsA, patients who were biologic naive but may have had experience with a maximum of 1 csDMARD, including those with enthesitis, and who were in ModDA at baseline had a higher probability of achieving treatment targets (cDAPSA REM or LDA) at Week 52 with continued APR treatment compared with those with HDA.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.Disclosure of Interests:Peter Nash Consultant of: AbbVie, BMS, Celgene, Gilead/Galapagos, GSK, Janssen, Lilly, MSD, Novartis, Pfizer, and Samsung, Grant/research support from: AbbVie, BMS, Celgene, Gilead/Galapagos, GSK, Janssen, Lilly, MSD, Novartis, Pfizer, and Samsung, Sven Richter Employee of: Amgen Inc., Shauna Jardon Employee of: Amgen Inc., Lichen Teng Employee of: Amgen Inc., Jessica A. Walsh Consultant of: AbbVie, Amgen Inc., Janssen, Lilly, Merck, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen Inc., Janssen, Lilly, Merck, Novartis, Pfizer, and UCB.