20 5 th World Psoriasis & Psoriatic Arthritis Conference 2018
P042 CLINICAL RESPONSE AFTER GUSELKUMAB TREATMENT AMONG ADALIMUMAB PASI 90 NON- RESPONDERS : RESULTS FROM THE VOYAGE 1 AND 2
TRIALS Christopher Griffith 1 , Marc Alexander Radtke 2 , Sang Woong Youn 3 , Robert Bissonnette 4 , Michael Song 5 , Yasmine Wasfi 5 , Bruce Randazzo 5 , Yin You 5 , Yaung-Kaung Shen 5 , Bruce Strober 6
1
Dermatology Centre , Salford Royal Hospital , University of Manchester , UK , 2 Universitaetsklinik Hamburg-Eppendorf , Hamburg , Germany , 3 Seoul National University College of Medicine , Bundang Hospital , Seongnam City , South Korea , 4 Innovaderm Research , Montreal , QC , Canada , 5 Janssen Research & Development , LLC , Spring House , PA , USA , 6 University of Connecticut Health Center , Farmington , Connecticut and Probity Medical Research , Waterloo , Ontario , Canada
Objective : To evaluate the levels of response to guselkumab ( GUS ) among adalimumab ( ADA ) PASI 90 non-responders in the VOYAGE 1 and VOYAGE 2 trials . Materials / Methods : In VOYAGE 1 ( n = 837 ), patients were randomized to GUS 100 mg at Weeks ( Wks ) 0 / 4 / 12 , then every 8 wks ; placebo ( PBO ) at Wks 0 / 4 / 12 followed by GUS 100 mg at Wks 16 / 20 and then every 8 wks ; or ADA 80 mg at Wk 0 , 40 mg at Wk 1 , and 40 mg every 2 wks through Wk 47 . In VOYAGE 2 ( n = 992 ), patients were randomized to GUS 100 mg at Wks 0 / 4 / 12 / 20 ; PBO at Wks 0 / 4 / 12 then GUS 100 mg at Wks 16 / 20 ; or ADA 80 mg at Wk 0 , 40 mg at W1 , and then every 2 wks through Wk 23 . ADA PASI 90 non-responders initiated GUS at Wk 52 ( VOYAGE 1 ) or at Wk 28 ( VOYAGE 2 ) and continued GUS treatment through Wk 100 . Here we report PASI 100 , PASI 90 , IGA 0 ( cleared ) and IGA 0 / 1 ( cleared / minimal disease ), Dermatology Quality of Life Index ( DLQI ), and Psoriasis Symptom and Sign Diary ( PSSD ) outcomes among these ADA PASI 90 non-responders after initiating GUS treatment through Wk 100 . Results : In VOYAGE 1 , among 138 ADA-treated PASI 90 nonresponders who initiated GUS treatment at Wk 52 , a PASI 90 response was achieved by 75.0 % of patients at Wk 76 , and 72.6 % of patients at Wk 100 . At Wk 100 , 78.5 % of patients achieved an IGA 0 / 1 response , 74.8 % of patients reported a DLQI 0 / 1 score , 33.3 % of patients reported a PSSD symptom score of 0 , and 18.9 % reported a PSSD sign score of 0 . In VOYAGE 2 , among 112 ADA-treated PASI 90 non-responders who initiated GUS at Wk 28 , a PASI 90 response was achieved by 66.1 % of patients at Wk 48 and 75.5 % of patients at Wk 100 . At Wk 100 , 81.0 % of patients achieved an IGA 0 / 1 response , 65.3 % of patients reported a DLQI 0 / 1 score , 32.6 % of patients reported a PSSD symptom score of 0 , and patients 18.0 % reported a PSSD sign score of 0 . Conclusions : Among ADA PASI 90 non-responders , GUS treatment provided robust levels of efficacy , which were maintained through Wk 100 .
P043 CONSISTENCY OF RESPONSE BY WEIGHT ACROSS SUBGROUPS OF PATIENTS WITH PSORIASIS TREATED WITH GUSELKUMAB : RESULTS FROM THE VOYAGE 1
AND 2 TRIALS Kim Papp 1 , Jeffrey Crowley 2 , Diana Rubel 3 , Ian Landells 4 , Michael Song 5 , Yasmine Wasfi 5 , Yin You 5 , Yaung-Kaung Shen 5 , Diamant
Thaci 6 1
Clinical Research and Probity Research , Inc ., Waterloo , Ontario , Canada ,
2
Bakersfield Dermatology and Skin Cancer Medical Group , Bakersfield , CA , USA , 3 Woden Dermatology , Phillip ACT 2606 , Australia , 4 Nexus Clinical Research , St . John ’ s Newfoundland , CA , 5 Janssen Research & Development , LLC , Spring House , PA , USA , 6 Universitatsklinikum Schleswig- Holstein-Lubeck , Germany
Objective : To evaluate the consistency of response of guselkumab ( GUS ) across predetermined weight quartile subgroups of psoriasis patients .
Materials / Methods : In VOYAGE 1 ( n = 837 ) and VOYAGE 2 ( n = 992 ), patients were randomized to GUS 100 mg at Weeks 0 / 4 / 12 / 20 ; placebo ( PBO ) at Weeks 0 / 4 / 12 followed by GUS 100 mg at Weeks 16 / 20 ; or ADA 80 mg at Week 0 , 40 mg at Week 1 , and 40 mg every 2 weeks through Week 23 . The co-primary endpoints were the proportions of GUS vs PBO patients achieving : 1 ) ≥90 % improvement in PASI score ( PASI 90 ), and 2 ) cleared / minimal disease ( IGA 0 / 1 ) responses at Week 16 . Response rates across endpoints were evaluated for predetermined subgroups by baseline weight quartiles . Results : Pooled data from the two studies at Week 16 and Week 24 demonstrated that patients in the guselkumab group achieved substantially higher clinical responses compared with placebo at Week 16 and ADA at Week 24 across all quartiles of weight as cutoffs . At Week 16 , for each quartile , defined by < 74.6 , ≥74.6 – < 86.4 , ≥86.4 – < 100 , and ≥100 kg , the proportions of GUS patients with a PASI 90 response were 76.0 %, 78.6 %, 66.2 %, and 65.2 %, respectively and the proportions with an IGA 0 / 1 response were 89.1 %, 88.6 %, 78.7 %, and 82.6 %, respectively . The proportions of PBO patients with a PASI 90 response by these quartiles were 5.0 %, 2.9 %, 1.2 %, and 0.9 %, respectively and the proportions with an IGA 0 / 1 response were 11.6 %, 10.5 %, 4.9 %, and 3.5 %, respectively . At Week 24 , the proportions of GUS patients with a PASI 90 response by weight quartile were 79.7 %, 81.1 %, 75.1 %, and 73.4 %, respectively and the proportions with an IGA 0 / 1 response were 85.9 %, 88.1 %, 83.1 %, and 78.3 %, respectively . The proportions of ADA patients with a PASI 90 response by these quartiles were 62.4 %, 66.0 %, 52.7 %, and 35.5 %, respectively and the proportions with an IGA 0 / 1 response were 70.9 %, 76.5 %, 61.1 %, and 45.2 %, respectively . Conclusions : The efficacy of GUS treatment was demonstrated across all predefined weight quartiles and high efficacy responses were observed in psoriasis patients without regard to weight .
P044 IMPACT OF CLINICAL SPECIALTY SETTING ON DISEASE MANAGEMENT IN PATIENTS WITH
PSORIATIC ARTHRITIS Wolf-Henning Boehncke 1 , Rudolf Horváth 2 , Ediz Dalkiliç 3 , Sónia A . L . Lima 4 , Masato Okada 5 , Maja Hojnik 6 , Fabiana Ganz 7 , Ennio
Lubrano 8 1
Geneva Univ . Hospitals and Univ . of Geneva , Geneva , Switzerland , 2 Univ . Hospital Motol , Prague , Czech Republic , 3 Uludağ Univ . Sch . of Med ., Gorukle , Bursa , Turkey , 4 ABC Med . Sch ., Santo André , Brazil , 5 St . Luke ’ s International Hospital , Tokyo , Japan , 6 AbbVie , Ljubljana , Slovenia , 6 AbbVie AG , Baar , Switzerland , 8 Univ . of Molise , Campobasso , Italy
Introduction : Evidence suggests that timely and effective management can improve long-term outcomes in patients ( pts ) with psoriatic arthritis ( PsA ); however factors influencing treatment management decisions are not well understood . Objective : To evaluate the association between the clinical specialty setting and time from inflammatory musculoskeletal symptom onset to PsA diagnosis and to different management steps in pts with a diagnosis of PsA . Methods : LOOP is a large cross-sectional , multi-center , observational study conducted in 17 countries across Western and Eastern Europe , Latin America , and Asia . Adult pts ( ≥18 years ) with a suspected or an established diagnosis of PsA routinely visiting a rheumatologist ( rheum ), dermatologist ( derm ) or non-rheum / nonderm site were eligible to participate in this study . Each enrolled patient in the study was assessed by both rheum and derm . Main endpoints assessed were time from inflammatory musculoskeletal symptom onset to PsA diagnosis , time from PsA diagnosis to first csDMARD and to first bDMARD , and time from first csDMARD to first bDMARD . Results : Of the 1483 pts enrolled in this study , 1273 pts with a confirmed diagnosis of PsA were included in this analysis . A ma- www . medicaljournals . se / acta