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Maintenance of Response Through up to 4 Years of Continuous Guselkumab Treatment of Psoriasis in the VOYAGE 2 Phase 3 Study

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Abstract

Background

Guselkumab effectively treats moderate-to-severe psoriasis.

Objectives

Results of continuous guselkumab treatment through 4 years from VOYAGE 2 are presented.

Methods

At baseline, 992 patients were randomized to receive guselkumab 100 mg every 8 weeks, placebo, or adalimumab 40 mg every 2 weeks. Placebo-treated patients crossed over to guselkumab at week 16. Weeks 28–76 incorporated randomized withdrawal, and all patients received open-label guselkumab through to week 204. Efficacy was analyzed using pre-specified treatment failure rules (patients were considered nonresponders after discontinuing due to lack of efficacy, worsening of psoriasis, or use of a prohibited treatment). There was no missing data imputation after treatment failure rules. Safety was analyzed through 4 years.

Results

The proportions of guselkumab-treated patients who achieved and maintained designated clinical responses at weeks 100 and 204, respectively, were as follows: at least a 75% improvement in Psoriasis Area and Severity Index from baseline (PASI 75): 94.1% and 92.3%; PASI 90: 79.1% and 79.7%; PASI 100: 48.4% and 51.0%; Investigator’s Global Assessment (IGA) score of 0/1: 83.1% and 81.9%; IGA score of 0: 52.7% and 52.7%; Dermatology Life Quality Index score of 0/1: 70.2% and 69.1%; Psoriasis Symptoms and Signs Diary (PSSD) symptom score of 0: 35.7% and 39.7%; PSSD sign score of 0: 22.0% and 27.2%; ≥ 5% improvement in Short Form-36 (SF-36) physical component score: 48.8% and 45.0%; ≥ 5% improvement in SF-36 mental component score: 45.1% and 43.2%; Hospital Anxiety and Depression Score (HADS)-anxiety score ≥ 8: 22.9% and 21.7%; and HADS-depression score ≥ 8: 16.6% and 21.0%. Similar findings were reported for the adalimumab → guselkumab group. No new safety signals were identified.

Conclusions

High efficacy levels were maintained from week 100 through to week 204 with continuous guselkumab treatment, across multiple endpoints, in VOYAGE 2. Guselkumab was well tolerated.

Clinical Trial Registration

NCT02207244.

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Acknowledgements

The authors thank Kristin Ruley Sharples, Ph.D., of Janssen Scientific Affairs, LLC (Horsham, PA), for her writing and editorial support in the preparation of this article.

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Authors and Affiliations

  1. Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany

    Kristian Reich

  2. Department of Dermatology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

    April W. Armstrong

  3. Department of Medicine, The University of Melbourne, St. Vincent’s Hospital Melbourne and Probity Medical Research, Skin Health Institute, Carlton, VIC, Australia

    Peter Foley

  4. Janssen Research & Development, LLC, Spring House, PA, USA

    Michael Song, Megan Miller, Y. K. Shen & Yin You

  5. Janssen Global Services, LLC, Malvern, PA, USA

    Chenglong Han

  6. Medical College of Wisconsin, Milwaukee, WI, USA

    Kenneth B. Gordon

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  1. Kristian Reich
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Corresponding author

Correspondence to Kristian Reich.

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Funding

This study was funded by Janssen Research & Development, LLC.

Conflict of interest

K. Reich has served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Covagen, Dermira, Eli Lilly, Forward Pharma, Fresenius Medical Care, Galapagos, GlaxoSmithKline, Janssen, Janssen-Cilag, Kyowa Kirin, Leo Pharma, Medac, Merck Sharp & Dohme, Novartis, Miltenyi Biotec, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB, Valeant, and Xenoport. A.W. Armstrong has served as a research investigator and/or consultant to AbbVie, Janssen, Eli Lilly, Leo Pharma, Novartis, UCB, Ortho Dermatologics, Dermira, KHK, Sanofi, Regeneron, Sun Pharma, Bristol Myers Squibb, Dermavant, and Modernizing Medicine. P. Foley has served as an advisor and/or been a consultant for and/or received speaker’s bureau/honoraria and/or received research and/or travel grants from and/or participated in clinical trials (investigator) for the following companies: AbbVie, Amgen, Astra Zeneca, Bristol Myers Squibb, Boehringer Ingelheim, Botanix, Celgene, Celtaxsys, CSL, Cutanea, Dermira, Eli Lilly and Company, Galderma, Geneseq, Genetech, GlaxoSmithKline, Hexima, Janssen, Leo Pharma, Mayne Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Reistone, Roche, Sanofi, Sun Pharma, UCB Pharma, Valeant, and Wintermute. K.B. Gordon has received research/grant support from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, and UCB Pharma, and honoraria for consultation from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, Eli Lilly, Janssen, Novartis, and UCB Pharma. M. Song, M. Miller, Y.K. Shen, and Y. You are employees of Janssen Research & Development, LLC, and C. Han is an employee of Janssen Global Services, LLC, and all own stock in Johnson & Johnson, of which Janssen is a subsidiary.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

All participants provided written informed consent prior to any study-related procedures.

Consent to participate

All participants provided written informed consent prior to any study-related procedures.

Consent for publication

Patients signed informed consent regarding publishing their data.

Availability of data and materials

The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu. Datasets related to this article will be available by request or at https://www.clinicaltrials.gov/ (NCT02207244) when the study concludes.

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Reich, K., Armstrong, A.W., Foley, P. et al. Maintenance of Response Through up to 4 Years of Continuous Guselkumab Treatment of Psoriasis in the VOYAGE 2 Phase 3 Study. Am J Clin Dermatol 21, 881–890 (2020). https://doi.org/10.1007/s40257-020-00555-7

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  • DOI: https://doi.org/10.1007/s40257-020-00555-7

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