14 5 th World Psoriasis & Psoriatic Arthritis Conference 2018
P026 IMPROVEMENTS IN WORK PRODUCTIVITY WITH UP TO 104 WEEKS OF APREMILAST MONOTHERAPY: RESULTS FROM A PHASE 3B, RANDOMIZED, CONTROLLED STUDY IN BIOLOGIC-NAIVE SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS Philip J. Mease 1, Dafna D. Gladman 2, Eric K. Davenport 3, Xiaolei Zhou 3, Benoit Guerette 4, Lichen Teng 4, Satyin Kaura 4, Peter Nash 5
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Swedish Medical Center and University of Washington School of Medicine, Seattle, WA, USA, 2 Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, 3 RTI Health Solutions, Research Triangle Park, NC, USA, 4 Celgene Corporation, Summit, NJ, USA, 5 University of Queensland, Brisbane, Australia
Introduction: PsA patients may have impaired functioning in home or work activities. The phase 3b ACTIVE study assessed efficacy of apremilast( APR) monotherapy in biologic-naive subjects with active PsA who may have had exposure to 1 conventional DMARD. Objectives: Assess work productivity through Wk104. Methods: Subjects were randomized( 1:1) to APR 30 mg BID or placebo( PBO). Subjects whose SJC / TJC did not improve ≥10 % at Wk16 were eligible for early escape. At Wk24, remaining PBO subjects switched to APR. Work productivity and activity impairment were assessed at baseline( BL) and Wk16 using the WPAI: PsA; WPAI: PsA Absenteeism, Presenteeism, Work Productivity Loss, and Activity Impairment subscale scores range from 0 % to 100 %; higher scores indicate greater impairment. Work-related subscales were assessed in employed subjects; activity impairment was assessed in all subjects. Correlations were examined at Wk16 between WPAI: PsA subscale and SF-36v2 domain scores( Physical Functioning [ PF ], Bodily Pain [ Pain ], and Vitality [ VIT ]) associations with ACR20 response. Work productivity improvement was assessed to Wk104. Results: BL characteristics were similar between groups. At Wk16, APR improved work productivity and ability to carry out daily activities vs PBO, with greater mean improvements in overall Work Productivity Loss( p = 0.001) and Activity Impairment( p < 0.001). Estimated mean change in Absenteeism score was similar with APR vs PBO( p = 0.679). The Presenteeism score showed significant improvement with APR vs worsening with PBO( −10.8 % vs 4.1 %; P = 0.002). At Wk16, statistically significant correlations were observed between WPAI: PsA subscale( except Absenteeism) and SF-36v2 domain scores, as were associations with ACR20 response. In subjects randomized to APR at BL, Wk16 improvements were generally maintained to Wk104 in those continuing APR. Conclusions: In biologic-naive subjects with PsA, APR contributed to overall improvement in work productivity at Wk16, which correlated with SF-36v2 PF, Pain, and VIT scores and was associated with ACR20 response; improvements in WPAI: PsA subscale scores were generally maintained to Wk104. Prior Presentation: EULAR 2018
P027 EXAMINING DISEASE SEVERITY AND SYMPTOM IMPROVEMENT WITH PATIENT AND PHYSICIAN ASSESSMENTS: RESULTS FROM A PHASE IV ANALYSIS OF APREMILAST IN PATIENTS WITH MODERATE PLAQUE PSORIASIS Mark Lebwohl 1, J. Mark Jackson 2, Jerry Bagel 3, Eugenia Levi 4, Jerry Weaver 4, Linda Stein Gold 5, Ali Alikhan 6, Seth Forman 7, Benjamin Lockshin 8, Kristina Callis Duffin 9
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Icahn School of Medicine at Mount Sinai, New York, NY, 2 University of Louisville, Forefront Dermatology, Louisville, KY, 3 Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, 4 Celgene Corporation, Summit, NJ, 5 Henry Ford Health System, West Bloomfield, MI, 6 University of Cincinnati, Department of Dermatology, Cincinnati, OH, 7 Forward Clinical Trials, Tampa, FL, 8 DermAssociates, Rockville, MD, 9 University of Utah, Salt Lake City, UT, USA
Introduction: UNVEIL is the first study of apremilast in patients( pts) with moderate psoriasis( BSA 5 %-10 %) naive to biologic and systemic therapy. Objectives: Improvements on physician and pt assessments over 52wks are described. Methods: Pts with chronic moderate plaque psoriasis( BSA 5 %- 10 %; sPGA = 3 [ 0 – 5 scale ]) were randomized( 2:1) to apremilast 30 mg BID( APR) or placebo( PBO) for 16wks. Pts continued APR( APR / APR) or switched from PBO to APR( PBO / APR) through Wk52( open-label treatment). Physician assessments were product of sPGA and BSA( PGAxBSA), proportion of pts who achieved sPGA score 0( clear) or 1( almost clear) and PGAxBSA-75( ≥75 % improvement from baseline [ BL ]). Pt assessments were Dermatology Life Quality Index( DLQI), pruritus VAS( 0 – 100 mm), Treatment Satisfaction Questionnaire for Medication( TSQM), and Pt’ s Global Assessment( PtGA [ 0 – 4 scale ]). Results: In randomized pts( PBO n = 73; APR n = 148), mean BL BSA was 7.2 %, PGAxBSA was 21.8, DLQI was 11.0, and pruritus VAS was 56.6mm. At Wk16, mean improvement in PGAxBSA was greater with APR vs PBO( −48.1 % vs −10.2 %; P < 0.0001); more pts achieved sPGA 0 or 1 and PGAxBSA-75 with APR vs PBO( 30.4 % vs 9.6 % and 35.1 % vs 12.3 %). At Wk16 achievement of DLQI response( ≥5-point decrease in pts with BL DLQI > 5) was greater with APR vs PBO( 63.8 % vs 34.5 %), as were pruritus VAS response( improvement ≥20 %: 62.8 % vs 45.2 %) and TSQM global satisfaction( 63.2 vs 48.7) and effectiveness( 57.3 vs 38.8). More pts had PtGA ≤ 1 with APR vs PBO( 33.8 % vs 20.5 %). At Wk52, PGAxBSA changes were −42.2 %( PBO / APR) and −55.5 %( APR / APR); 45.3 %( PBO / APR) and 42.1 %( APR / APR) of pts achieved PGAxBSA-75, 35.9 %( PBO / APR) and 33.1 %( APR / APR) achieved sPGA response, 55.6 %( PBO / APR) and 59.4 %( APR / APR) achieved DLQI response, and 68.8 %( PBO / APR) and 66.9 %( APR / APR) achieved pruritus VAS response. TSQM global satisfaction( PBO / APR 59.2; APR / APR 59.9) and effectiveness( PBO / APR 57.7; APR / APR 54.1) were similar between groups at Wk52; 42.2 %( PBO / APR) vs 37.2 %( APR / APR) had PtGA ≤ 1. Conclusion: Physician and pt assessments improved with APR up to 52wks in biologic- and systemic-naive pts with moderate psoriasis. Prior Presentation: AAD 2018
P028 HEMOGLOBIN A1C AND WEIGHT CHANGES WITH APREMILAST IN PATIENTS WITH PSORIASIS AND PSORIATIC ARTHRITIS: POOLED LABORATORY ANALYSIS OF THE PHASE 3 ESTEEM AND PALACE
TRIALS Luis Puig 1, Neil Korman 2, Chiara Greggio 3, Joshua Cirulli 3, Lichen Teng 3, Vinod Chandran 4, Majed Khraishi 5, Nehal N. Mehta 6
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Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, 2 Case Western University and University Hospitals Cleveland Medical Center, Cleveland, OH, 3 Celgene Corporation, Summit, NJ, 4 University of Toronto and Krembil Research Institute, University Health Network, Toronto, ON, Canada,
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Memorial University of Newfoundland, St. Johns, NL, Canada, 6 National Heart, Lung and Blood Institute, Bethesda, MD
Introduction: Psoriasis and psoriatic arthritis( PsA) are associated with high prevalence of obesity and metabolic syndrome. In phase 3 trials, apremilast, an oral PDE4 inhibitor, was efficacious in patients( pts) with moderate to severe plaque psoriasis( ESTEEM 1 and 2 [ EST ]) and active PsA( PALACE 1 – 3 [ PAL ]). Objectives: To explore potential effects of apremilast on metabolic parameters, we assessed weight change and A1c in pts receiving placebo( PBO) or apremilast 30 mg twice daily( APR) in a pooled analysis of EST and PAL. www. medicaljournals. se / acta