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AB1473 (2022)
EFFICACY RESPONSES ACROSS DISEASE SEVERITY AND TREATMENT HISTORY SUBGROUPS OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS TREATED WITH GUSELKUMAB: POOLED RESULTS FROM VOYAGE-1 AND VOYAGE-2 THROUGH 5 YEARS
K. Gordon1, J. F. Merola2, P. Foley3, O. Choi4, D. Chan4, M. Miller5, Y. You6, Y. K. Shen6, Y. W. Yang7, A. Blauvelt8
1Medical College of Wisconsin, Department of Dermatology, Milwaukee, WI, United States of America
2Harvard Medical School, Brigham and Women’s Hospital, Department of Dermatology, Boston, MA, United States of America
3The University of Melbourne, St. Vincent’s Hospital Melbourne and Probity Medical Research, Skin Health Institute, Department of Dermatology, Carlton, VIC, Australia
4Janssen Scientific Affairs, LLC, Department of Dermatology, Horsham, PA, United States of America
5Janssen Research & Development, LLC, Department of Immunology, Spring House, PA, United States of America
6Janssen Research & Development, LLC, Department of Clinical Biostatistics, Spring House, PA, United States of America
7Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Department of Dermatology, Horsham, PA, United States of America
8Oregon Medical Research Center, Department of Dermatology, Portland, OR, United States of America

Background: The VOYAGE-1 and VOYAGE-2 phase 3 studies evaluated efficacy and safety of guselkumab (GUS) in patients with moderate-to-severe plaque psoriasis.


Objectives: To assess the five-year efficacy of GUS by baseline disease characteristics and treatment history.


Methods: This study evaluated 1829 patients randomized to GUS, placebo (PBO)→GUS, and adalimumab (ADA) →GUS from the VOYAGE-1 and VOYAGE-2 trials. All patients received open-label GUS 100 mg every 8 weeks (Q8W) during Week (W) 52 to W252 in VOYAGE-1 and during W76 to W252 in VOYAGE-2. The proportions of combined GUS patients (including PBO→GUS and ADA→GUS) achieving Investigator’s Global Assessment of cleared or minimal (IGA-0/1) and Psoriasis Area and Severity Index (PASI) 90 response were evaluated from W100 to W252 by baseline PASI (<20/≥20) and IGA (<4/=4) scores, body surface area (BSA; <20%/≥20%), and prior psoriasis treatments. Analysis was performed using observed data after applying treatment failure rules.


Results: At W252, proportions of combined GUS patients achieving IGA 0/1 or PASI 90, respectively, were comparable or numerically greater for patients with baseline PASI < 20 (85.4%; 81.1%) vs PASI ≥ 20 (81.4%; 83.8%); IGA < 4 (85.1%; 82.7%) vs IGA = 4 (78.9%; 81.1%); BSA < 20% (85.1%; 82.7%) vs BSA ≥ 20% (82.6%; 82.0%); no prior phototherapy (83.3%; 84.0%) vs prior phototherapy (83.8%; 81.1%); no prior non-biologic systemic therapy (84.5%; 83.0%) vs prior non-biologic systemic therapy (83.2%; 82.0%); and no prior biologics (85.3%; 83.8%) vs prior biologics (76.7%; 76.3%). This trend was consistent at each timepoint evaluated from W100 to W252.


Conclusion: This analysis demonstrated that the high degree of efficacy of GUS treatment is durable through 5 years among broad subpopulations of patients with varying disease severity characteristics and previous psoriasis treatments.


REFERENCES:

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Disclosure of Interests: Kenneth Gordon Grant/research support from: AbbVie, Almirall, Amgen, BMS, Celgene, Dermira, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Sun Pharma, and UCB Pharma, Joseph F. Merola Consultant of: AbbVie, Arena, Avotres, Biogen, Bristol-Myers Squibb, Celgene, Dermavant, Eli Lilly, EMD Sorono, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB pharma, Peter Foley Speakers bureau: AbbVie, Celgene, Eli Lilly, Galderma, GSK, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Roche, and Valeant, Consultant of: AbbVie, Amgen, Arcutis, Aslan, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Celtaxsys, CSL, Cutanea, Dermira, Eli Lilly, Galderma, Genentech, GSK, Hexima, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals Inc, Reistone, Roche, Sanofi, Sun Pharma, UCB Pharma, and Valeant, Grant/research support from: grant/research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Sanofi, and Sun Pharma; and travel grants from AbbVie, Eli Lilly, Galderma, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Roche, Sanofi, and Sun Pharma, Olivia Choi Shareholder of: may own stock or stock options in Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC, Daphne Chan Shareholder of: may own stock or stock options in Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC, Megan Miller Shareholder of: may own stock or stock options in Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Yin You Shareholder of: may own stock or stock options in Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Yaung-Kaung Shen Shareholder of: may own stock or stock options in Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Ya-Wen Yang Shareholder of: may own stock or stock options in Johnson & Johnson, Employee of: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Andrew Blauvelt Speakers bureau: AbbVie, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Eli Lilly, Evommune, Forte, Galderma, Incyte, Janssen, Leo Pharma, Novartis, Pfizer, Rapt, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, and UCB Pharma, Consultant of: AbbVie, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Eli Lilly, Evommune, Forte, Galderma, Incyte, Janssen, Leo Pharma, Novartis, Pfizer, Rapt, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, and UCB Pharma

Citation: , volume 81, supplement 1, year 2022, page 1842
Session: Validation of outcome measures and biomarkers (Publication Only)