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