AB0557 ACHIEVING TREATMENT TARGETS IN PSORIATIC ARTHRITIS WITH APREMILAST IN CANADIAN PRACTICE: REAL WORLD RESULTS FROM APPRAISE
Authors: V. Chandran, L. Bessette, C. Thorne, M. Sheriff, P. Rahman, D. D. Gladman, S. Anwar, J. Jelley, A. J. Gaudreau, M. Chohan, J. S. Sampalis
Journal: Annals of the Rheumatic Diseases (2021)

Background: Real-world evidence on achieving treatment targets with apremilast (APR) in patients (pts) with PsA is limited. In the phase 3 PALACE trials, pts reached remission (REM)/low disease activity (LDA) targets at 52 wks most frequently when early APR treatment was initiated and pts were in moderate disease activity, as measured by Clinical Disease Activity Index for PsA (cDAPSA) score. In APPRAISE, we assessed APR effectiveness/tolerability in pts with PsA in routine clinical practice in Canada. Objectives: This interim efficacy analysis focused on the available data on APR effectiveness measuring rate of achieving cDAPSA REM or LDA at 12 mos and Pt Acceptable Symptom Status (PASS) results. Methods: The prospective, multicenter, observational APPRAISE study assessed APR effectiveness/tolerability in adults with active PsA in routine clinical care enrolled from July 2018-March 2020. Pts were followed from treatment initiation to 12 mos, with visits suggested every 4 mos. The primary effectiveness endpoint was the rate of achieving at least LDA (cDAPSA &lt;14) at 12 mos. Pt-reported outcome measures were assessed. Data reported are as observed in pts continuing APR treatment. Results: In total, 101 pts were enrolled in APPRAISE. Mean age was 52 yrs; 56% were women. Mean (SD) PsA duration at baseline (BL) was 6 (8) yrs. Oligoarticular disease (≤4 joint involvement) was most common (41%), followed by polyarticular (35%). Most pts (92%) received prior conventional DMARDs and 17% received prior biologic therapy; concomitant MTX was reported in 41% at BL. By 12 mos, 41/101 enrolled pts discontinued, 35 reached 12 mos follow-up (4 mos: n=92; 8 mos: n=61), and 25 have yet to reach 12 mos. The majority (92%) of discontinuations due to lack/loss of effectiveness or AEs occurred within 4-8 mos. AEs were primarily GI related early in treatment. The proportion of pts with continued APR achieving cDAPSA REM/LDA treatment targets increased significantly over time (Figure 1). Significant reductions were seen over 12 mos in swollen/tender joint counts and plaque psoriasis, with reduced mean (SD) body surface area of −4% (9%) (Table 1). Prevalence of dactylitis/enthesitis at BL, 4, 8, and 12 mos was 17%/33%, 9%/24%, 5%/19%, and 0%/21%, respectively. Pain assessment (VAS) significantly improved over time. The proportion of pts achieving PASS with continued APR increased significantly over 12 mos (BL: 27%; 12 mos: 65%) (Figure 1). COVID restrictions impacted in-office assessment visits, necessitating reliance on virtual visits. Conclusion: Pts with PsA receiving APR were assessed at regular intervals in routine clinical care in Canada. This interim analysis revealed a greater number of pts receiving APR (66%) who completed the 12-mo follow-up achieved REM or LDA, as measured by cDAPSA over 12 mos. A majority of pts (65%) reported satisfaction with their disease state, as measured by PASS. No new safety signals were observed. Table 1. Change in Clinical Parameters and Pt-Reported Outcomes From BL to 4, 8, and 12 Mos Outcome Measure*, Mean (SD ) BL (n = 101 ) 4 Mos (n = 92 ) 8 Mos (n = 61 ) 12 Mos (n = 35 ) Disease/Clinical Parameters Tender joint count (0-68) 7.5 (6.7) −2.5 (6.3)* −3.9 (5.2)* −2.2 (6.4) Swollen joint count (0-66) 5.4 (5.4) −3.0 (4.5)* −3.1 (4.3)* −3.1 (4.4)* PhGA 42.9 (18.8) −19.0 (24.6)* −24.2 (24.2)* −21.2 (26.3)* Body surface area, % 3.1 (6.1) −2.2 (6.0)* −2.7 (7.5)* −4.2 (9.1)* cDAPSA 22.2 (13.3) −7.9 (12.1)* −10.1 (13.5)* −6.9 (12.0)* Pt-Reported Outcomes PtGA, mm 50.0 (24.6) −10.2 (27.5)* −9.1 (31.9)* −3.6 (39.7) Pain, mm 48.3 (25.3) −9.5 (26.2)* −12.2 (28.7)* −7.3 (26.0) HAQ-DI 0.9 (0.7) −0.13 (0.5)* −0.15 (0.6) −0.1 (0.7) *Denotes significant change from BL ( P &lt;0.05) from paired-sample t -tests; note that mean change from BL may be greater than the mean BL value when improvements of large magnitude, for pts with relatively elevated BL values, are observed in samples with lower n’s. HAQ-DI = Health Assessment Questionnaire-Disability Index; PhGA = Physician’s Global Assessment; PtGA = Patient’s Global Assessment. Acknowledgements: This study was funded by Celgene and 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: Vinod Chandran Consultant of: AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Louis Bessette Consultant of: AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Janssen, Merck, Pfizer, Sanofi, Novartis, UCB, Grant/research support from: AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Janssen, Merck, Pfizer, Sanofi, Novartis, UCB, Carter Thorne Speakers bureau: AbbVie, Amgen, Celgene Corporation, Eli Lilly, Medexus/Medac, Merck, Novartis, Pfizer, Sandoz, Sanofi, Consultant of: Centocor, Medexus/Medac, Merck, Grant/research support from: Novartis, Pfizer, Maqbool Sheriff Speakers bureau: AbbVie, Celgene Corporation, Eli Lilly, Janssen, Merck, Pfizer, Sandoz, Proton Rahman Speakers bureau: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB, Dafna D Gladman Consultant of: AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB, Sabeen Anwar Consultant of: AbbVie, Amgen Inc., BMS, Novartis, and Pfizer, Grant/research support from: AbbVie, Amgen Inc., Eli Lilly, Janssen, and Pfizer, Jennifer Jelley Employee of: Amgen Canada Inc., Anne-Julie Gaudreau Employee of: Amgen Canada Inc., Manprit Chohan Employee of: Amgen Canada Inc., John S. Sampalis Employee of: JSS Medical Research.