Efficacy and safety of guselkumab, an anti‐interleukin‐23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the…
By A. Blauvelt, K. Papp, C. Griffiths, B. Randazzo, Y. Wasfi, Yaung-Kaung Shen, Shu Li, A. Kimball. Journal of American Academy of Dermatology, 2017
810 citations recorded by the source corpus.
Background: Guselkumab, an interleukin‐23 blocker, was superior to adalimumab in treating moderate to severe psoriasis in a phase II trial. Objectives: We sought to compare efficacy and safety of guselkumab with adalimumab and placebo in patients with psoriasis treated for 1 year. Methods: Patients were randomized to guselkumab 100 mg (weeks 0 and 4, then every 8 weeks; n = 329); placebo→guselkumab (weeks 0, 4, and 12 then guselkumab at weeks 16 and 20, then every 8 weeks; n = 174); or adalimumab (80 mg week 0, 40 mg week 1, then 40 mg every 2 weeks through week 47; n = 334). Physician‐reported outcomes (Investigator Global Assessment, Psoriasis Area and Severity Index [PASI]), patient‐reported outcomes (Dermatology Life Quality Index, Psoriasis Symptoms and Signs Diary), and safety were evaluated through week 48. Results: Guselkumab was superior (P < .001) to placebo at week 16 (85.1% vs 6.9% [Investigator Global Assessment score of 0/1 (cleared/minimal)] and 73.3% vs 2.9% [90% or greater improvement in PASI score from baseline (PASI 90)]). Guselkumab was also superior (P < .001) to adalimumab for Investigator Global Assessment 0/1 and PASI 90 at week 16 (85.1% vs 65.9% and 73.3% vs 49.7%), week 24 (84.2% vs 61.7% and 80.2% vs 53.0%), and week 48 (80.5% vs 55.4% and 76.3% vs 47.9%). Furthermore, guselkumab significantly improved patient‐reported outcomes through week 48. Adverse event rates were comparable between treatments. Limitations: Analyses were limited to 48 weeks. Conclusions: Guselkumab demonstrated superior efficacy compared with adalimumab and was well tolerated in patients with psoriasis through 1 year.
Subfields: Dermatology, Immunology, Rheumatology
View Paper: https://www.semanticscholar.org/paper/16d673c5816a80fd4203eb972b99da4038b7c497
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Citations in the corpus
- Psoriasis Pathogenesis and the Development of Novel, Targeted Immune Therapies (2017, neutral): “Two Phase III clinical trials (VOYAGE 1 and 2) for the treatment of moderate-to-severe plaque psoriasis with guselkumab were recently published.(77,78) Both VOYAGE trials were 48-week studies that compared guselkumab with placebo and adalimumab, although the VOYAGE 2 trial also evaluated the clinica”
- The Immunologic Role of IL-17 in Psoriasis and Psoriatic Arthritis Pathogenesis (2018, neutral): “Guselkumab [92] p19 subunit (IL-23) 2017 psoriasis”
- Psoriasis Pathogenesis and Treatment (2019, background): “3% receiving a PASI 90 response at week 16 [204,205].”