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Maintenance of clinical response and consistent safety profile with up to 3 years of continuous treatment with guselkumab: Results from the VOYAGE 1 and VOYAGE 2 trials - 06/02/20

Doi : 10.1016/j.jaad.2019.11.040 
Kristian Reich, MD a, , Christopher E.M. Griffiths, MD b, Kenneth B. Gordon, MD c, Kim A. Papp, MD, PhD d, Michael Song, MD e, Bruce Randazzo, MD, PhD e, f, Shu Li, PhD e, Yaung-Kaung Shen, PhD e, Chenglong Han, MD e, Alexa B. Kimball, MD, MPH g, April W. Armstrong, MD, MPH h, Peter Foley, MD i, Andrew Blauvelt, MD, MBA j
a Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation Center, Hamburg, Germany 
b Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester NIHR Biomedical Research Centre, Manchester, United Kingdom 
c Medical College of Wisconsin, Milwaukee, Wisconsin 
d K Papp Clinical Research and Probity Research, Inc, Waterloo, Ontario, Canada 
e Janssen Research & Development, LLC, Spring House, Pennsylvania 
f Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 
g Department of Dermatology, Harvard Medical School, Boston, Massachusetts 
h University of Southern California, Los Angeles, California 
i The University of Melbourne, St. Vincent's Hospital Melbourne and Probity Medical Research, Skin & Cancer Foundation Inc., Carlton, Victoria, Australia 
j Oregon Medical Research Center, Portland, Oregon 

Reprint requests: Kristian Reich, MD, Professor for 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.Professor for Translational Research in Inflammatory Skin DiseasesInstitute for Health Services Research in Dermatology and Nursing University Medical Center Hamburg-EppendorfMartinistr 52 20246HamburgGermany
Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Thursday 06 February 2020
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Abstract

Background

Long-term maintenance treatment is required for patients with psoriasis.

Objectives

To evaluate the efficacy and safety of guselkumab in patients with moderate to severe psoriasis through 3 years of treatment.

Methods

In 2 ongoing, phase 3 trials of guselkumab (VOYAGE 1 and VOYAGE 2), the proportions of patients achieving at least 90% and 100% improvement in the Psoriasis Area and Severity Index (PASI 90 and PASI 100, respectively) and Investigator's Global Assessment (IGA) scores of 0/1 and 0 were summarized for the guselkumab group (including placebo-to-guselkumab crossover). Patients who met treatment failure rules were considered nonresponders. Safety outcomes (rates/100 patient-years [PY]) were evaluated based on data pooled across studies through week 156.

Results

Three-year response rates for the guselkumab group in VOYAGE 1 and VOYAGE 2, respectively, were 82.8% and 77.2% for PASI 90, 50.8% and 48.8% for PASI 100, 82.1% and 83.0% for IGA score of 0/1, and 53.1% and 52.9% for IGA score of 0. Safety event rates across studies occurred through week 156 as follows: serious adverse events, 5.68/100 PY; serious infections, 1.15/100 PY; nonmelanoma skin cancers, 0.28/100 PY; malignancies other than nonmelanoma skin cancer, 0.47/100 PY; and major adverse cardiovascular events, 0.28/100 PY. Week 156 and week 100 rates were consistent.

Limitations

There was no comparator arm beyond 1 year.

Conclusions

Guselkumab shows durable efficacy and a consistent safety profile in patients with moderate to severe psoriasis treated for up to 3 years.

Le texte complet de cet article est disponible en PDF.

Key words : adalimumab, efficacy, guselkumab, long-term, psoriasis, safety, VOYAGE 1, VOYAGE 2

Abbreviations used : AE, DLQI, HRQoL, IGA, IL, ISR, NRI, PASI, PASI 90, PASI 100, PSSD, PY, TNF, TFR


Plan


 Funding sources: VOYAGE 1 and VOYAGE 2 were funded by Janssen Research & Development, LLC, Spring House, PA.
 Disclosure: Dr Reich has served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Affibody, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, Covagen, Forward Pharma, Fresenius Medical Care, Galapagos, GlaxoSmithKline, Janssen-Cilag, Kyowa Hakko Kirin, LEO Pharma, Lilly, Medac, Merck Sharp & Dohme, Miltenyi, Novartis, Ocean Pharma, Pfizer, Samsung Bioepis, Sanofi, Takeda, UCB Pharma, Valeant, XBiotech, and Xenoport. Dr Griffiths has received honoraria and/or grants as an investigator, speaker, and/or advisory board member for AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, LEO Pharma, and Novartis. Dr Gordon has received research support and honoraria from AbbVie, Almirall, Amgen, BMS, Celgene, Dermira, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Sun Pharma, and UCB Pharma. Dr Papp has received honoraria or clinical research grants as a consultant, speaker, scientific officer, advisory board member, and/or Steering Committee member for AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite, Celgene, Coherus, Dermira, Dow Pharmaceuticals, Eli Lily, Galderma, Genentech, Gilead, GlaxoSmithKline, InflaRx GmbH, Janssen, Kyowa Hakko Kirin, LEO Pharma, MedImmune, Meiji Seika Pharma, Merck (MSD), Merck-Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-aventis, Sun Pharma, Takeda, and UCB. Dr Kimball has received honoraria as a consultant and/or investigator for AbbVie, Bristol-Myers Squibb, Janssen, Lilly ICOS LLC, Novartis, and Pfizer and received grants and/or funding for research for the residency/fellowship program as a principal investigator for AbbVie and Janssen Pharmaceuticals. Drs Song, Randazzo, Li, Shen, and Han are employees of Janssen Research & Development, LLC, (a subsidiary of Johnson & Johnson) and own stock in Johnson & Johnson. Dr Armstrong has received grants and/or honoraria as a research investigator, data safety monitoring board member, consultant, and/or speaker from AbbVie, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, Genentech, GlaxoSmithKline, Janssen, Leo Pharma, Menlo Therapeutics, Merck, Modernizing Medicine, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Science 37, Valeant, and UCB Pharma. Dr Foley has received grants, honoraria, and/or personal fees as a principal investigator, consultant, advisory board member, and/or speaker from AbbVie, Amgen, Botanix, Bristol-Myers Squibb, Celgene, CSL, Celtaxsys, Cutanea, Dermira, Eli Lilly, Galderma, Genentech, GSK, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Valeant, and UCB. Dr Blauvelt has served as a scientific advisor and clinical study investigator for AbbVie, Aclaris, Akros, Allergan, Almirall, Amgen, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermavant, Dermira, Inc, Eli Lilly and Company, FLX Bio, Forte, Galderma, Genentech/Roche, GlaxoSmithKline, Janssen, LEO Pharma, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Purdue Pharma, Regeneron, Revance, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB Pharma, Valeant, and Vidac, and as a paid speaker for AbbVie, Janssen, Regeneron, and Sanofi Genzyme.
 IRB approval status: Reviewed and approved by a total of 168 institutional review boards or ethics committees approved the study protocol.


© 2019  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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