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. 2024 Mar;25(2):315-325.
doi: 10.1007/s40257-023-00816-1. Epub 2023 Oct 7.

Guselkumab-Treated Patients with Plaque Psoriasis Who Achieved Complete Skin Clearance for ≥ 156 Consecutive Weeks: A Post-Hoc Analysis From the VOYAGE 1 Clinical Trial

Luis Puig  1 , Antonio Costanzo  2   3 , Elke M G J de Jong  4 , Tiago Torres  5   6 , Richard B Warren  7 , Robert Wapenaar  8 , Sven Wegner  9 , Patricia Gorecki  10 , Talia Gramiccia  11 , Maria Jazra  12 , Jozefien Buyze  13 , Curdin Conrad  14
Affiliations

Guselkumab-Treated Patients with Plaque Psoriasis Who Achieved Complete Skin Clearance for ≥ 156 Consecutive Weeks: A Post-Hoc Analysis From the VOYAGE 1 Clinical Trial

Luis Puig et al. Am J Clin Dermatol. 2024 Mar.

Abstract

Background: Treatment of moderate-to-severe plaque psoriasis with biologics, such as guselkumab, has demonstrated greater efficacy over traditional non-biologic treatments. However, given patient diversity, greater understanding of the relationship between patient characteristics, positive clinical outcomes, and long-term response to biologics is crucial for optimizing treatment choices.

Materials and methods: This post-hoc analysis of the 5-year VOYAGE 1 clinical trial compares baseline characteristics of patients maintaining a Psoriasis Area and Severity Index (PASI) score of 0 at all visits for ≥ 156 consecutive weeks (PASI = 0 group) with those that never achieve PASI = 0 (comparator group), using descriptive statistics and a multiple logistic regression model. Guselkumab plasma trough concentrations in both response groups were assessed from Weeks 4-156.

Results: Of patients who started guselkumab treatment at Week 0 or at Week 16 after switching from placebo, 22.7% (112/494) maintained PASI = 0 for ≥ 156 consecutive weeks. Numerical differences in baseline characteristics, including age, obesity, diabetes, PASI score, disease duration, smoking status, and psoriatic arthritis comorbidity, were identified between the PASI = 0 group and comparator group. Plasma guselkumab levels were consistently higher in the PASI = 0 group. Multiple logistic regression analysis revealed absence of diabetes, lower Dermatology Life Quality Index score at baseline, and higher Week 4 guselkumab plasma concentration as significantly (p < 0.05) associated with the PASI = 0 group.

Conclusion: A substantial (22.7%) number of guselkumab-treated patients in the VOYAGE 1 clinical trial maintained complete skin clearance for a consecutive period of ≥ 156 weeks. Factors associated with this outcome may suggest clinical benefits of holistic treatment approaches.

Trial registration: NCT02207231.

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Conflict of interest statement

LP reports consulting fees from AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, JS BIOCAD, Leo-Pharma, Lilly, Novartis, Pfizer, Sandoz, Samsung-Bioepis, and UCB; payment or honoraria from Janssen, Lilly, Novartis, and UCB; support for attending meetings and/or travel from Janssen and UCB; grants received from Abbvie, Almirall, Amgen, Boehringer Ingelheim, Janssen, Leo-Pharma, Lilly, Novartis, and UCB; and a non-financial relationship with the International Psoriasis Council. AC reports consulting fees from AbbVie and UCB; payment or honoraria from AbbVie, Almirall, Amgen, Galderma, Janssen, Lilly, Novartis, and UCB; support for attending meetings and/or travel from AbbVie; and participation on a Data Safety Monitoring Board and/or Advisory Board for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Janssen, Leo-Pharma, Lilly, Novartis, and UCB. EMGJdJ reports receiving research grants from AbbVie, BMS, Janssen Pharmaceutica, Leo Pharma, Lilly, Novartis, and UCB; and has acted as a consultant, paid speaker, and/or participated in research sponsored by companies that manufacture drugs used for the treatment of psoriasis or eczema, including AbbVie, Almirall, Amgen, Boehringer-Ingelheim, Celgene, Galapagos, Janssen Pharmaceutica, Leo Pharma, Lilly, Novartis, Sanofi, and UCB. TT reports consulting fees from AbbVie, Almirall, Amgen, Arena Pharmaceuticals, Biocad, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Leo Pharma, MSD, Novartis, Pfizer, Samsung-Bioepis, Sandoz, and Sanofi; payment or honoraria from AbbVie, Almirall, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Janssen, Leo Pharma, MSD, Novartis, Pfizer, Sandoz, and Sanofi; support for attending meetings and/or travel from AbbVie, Almirall, Janssen, Leo Pharma, MSD, Novartis, Pfizer, and Sanofi; and participation on a Data Safety Monitoring Board and/or Advisory Board for Samsung-Bioepis. RBW reports consulting fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, DiCE, GSK, Janssen, Leo, Lilly, Novartis, Pfizer, Sanofi, Sun Pharma, UCB, and UNION; payment or honoraria from AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Janssen, Leo, Lilly, Novartis, Pfizer, Sanofi, Sun Pharma, and UCB; and grants received from AbbVie, Almirall, Janssen, Leo, Lilly, Novartis, Pfizer, and UCB. RW holds stock at Johnson & Johnson and was a full-time employee of Janssen at the time of the study. SW is a full-time employee of and owns stock at Janssen. PG is a full-time employee at Janssen. TG is a full-time employee at Janssen. MJ holds stocks at Johnson & Johnson and is a full-time employee at Janssen. JB is a full-time employee at Janssen. CC reports consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, MSD, Novartis, Pfizer, Samsung, Sanofi, and UCB; payment or honoraria from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB; participation on a Data Safety Monitoring Board and/or Advisory Board for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Galderma, Janssen, LEO Pharma, MSD, Novartis, Pfizer, and UCB; grants received from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer; and leadership and/or fiduciary roles for the European Society for Dermatological Research and the Swiss Society for Dermatology and Venereology.

Figures

Fig. 1
Fig. 1
VOYAGE 1 clinical trial design, including open-label extension through Year 5. aThe last dose of guselkumab was administered at Week 252; efficacy was evaluated through Week 252. bSafety was evaluated through Week 264. ADA adalimumab, GUS guselkumab, q2w every 2 weeks, q8w every 8 weeks, R randomization
Fig. 2
Fig. 2
PASI score a comparison between the PASI = 0 group and comparator group over time and b cumulative percentage of patients achieving complete skin clearance in the PASI = 0 group (n = 112). Dotted line indicates that half of the patients who achieved PASI = 0 did so within 16 weeks. GUS guselkumab, PASI Psoriasis Area and Severity Index
Fig. 3
Fig. 3
Multiple logistic regression of factors influencing treatment response. Error bars represent 95% Wald confidence limits. This analysis represents ORs, where OR = 1 indicates exposure does not affect odds of maintaining PASI = 0, OR > 1 indicates factors associated with higher odds of maintaining PASI = 0, and OR < 1 refers to exposure associated with lower odds of maintaining PASI = 0. aCategorical scores for IGA at baseline were either 3 or 4. BMI body mass index, BSA body surface area, DLQI Dermatology Life Quality Index, GUS guselkumab, IGA Investigator Global Assessment, OR odds ratio, PASI Psoriasis Area and Severity Index, PsA psoriatic arthritis
Fig. 4
Fig. 4
Comparison of mean guselkumab serum concentration between the PASI = 0 group and comparator group over time. Guselkumab plasma trough concentrations were assessed prior to treatment and between Weeks 4 and 156 from the start of guselkumab treatment. Plasma levels at Weeks 4, 8, 16, and 24 were measured 4 weeks after guselkumab treatment; plasma levels at Week 12 and every 8 weeks until Week 156 were measured 8 weeks after guselkumab treatment. Guselkumab or placebo administrations during the first 156 weeks are indicated by dashed lines in the figure. From Week 28 onwards, only trough levels were assessed. Data from visits where n ≤ 3 have been excluded. GUS guselkumab, PASI Psoriasis Area and Severity Index
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References

    1. Armstrong A, Read C. Pathophysiology, clinical presentation, and treatment of psoriasis: a review. JAMA. 2020;323(19):1945–1960. - PubMed
    1. Gelfand JM, Weinstein R, Porter SB, Neimann AL, Berlin JA, Margolis DJ. Prevalence and treatment of psoriasis in the United Kingdom: a population-based study. Arch Dermatol. 2005;141(12):1537–1541. - PubMed
    1. Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014;70(3):512–516. - PubMed
    1. Puig L, Costanzo A, Munoz-Elias EJ, Jazra M, Wegner S, Paul CF, et al. The biological basis of disease recurrence in psoriasis: a historical perspective and current models. Br J Dermatol. 2022;186(5):773–781. - PMC - PubMed
    1. van Ee I, Deprez E, Egeberg A, Augustin M, Conrad C, Corazza V, et al. Freedom from disease in psoriasis: a Delphi consensus definition by patients, nurses and physicians. J Eur Acad Dermatol Venereol. 2022;36(3):403–412. - PMC - PubMed

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