Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study

Deodhar, Atul; Boehncke, Wolf‐Henning; Dong, Bin; Wang, Yuhua; Zhuang, Yanli; Barchuk, William; Xu, X. L.; Hsia, Elizabeth C.; Aelion, Jacob; Amarelo-Ramos, Juan; Balsa, Alejandro; Berghea, F.; Brzezicki, Jan; Burnette, Michael; Fretzin, Scott; García-Carazo, S.; Gladstein, Geoffrey; Gómez-Reino, Juan J.; Gooderham, Melinda; González-Fernández, Carlos; Gottlieb, Alice B.; Gratacós, Jordi; Haaland, Derek; Kamalova, Rima; Leszczyński, Piotr; Martı́n-Mola, Emilio; Maslyansky, Alexey; Navarro, Federico; Opriş, D.; Papp, Kim; Perlamutrov, Yu. N.; Philipp, Sandra; Racewicz, Artur; Ребров, А. П.; Rell‐Bakalarska, Maria; Rosmarin, David; Rubbert-Roth, Andrea; Shergy, William; Shirinsky, I.; Sonin, Dmitry; Stanislav, Marina; Сухарев, А. Е.; Temnikov, Vadim; Виноградова, И. Б.; Waytz, Paul; Yakushevich, Vladimir

doi:10.1016/s0140-6736(18)30952-8

Cited by 160 publications

(166 citation statements)

References 22 publications

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“…However, data on ACR response rates of brodalumab are limited because there have been few studies administrated at the approved dose of 210 mg, and no data on the suppression of joint destruction have been obtained . According to the results of a phase II study of guselkumab obtained to date, guselkumab has been shown to be superior to ustekinumab and to be approximately as effective as TNF inhibitors and IL‐17 inhibitors based on the ACR response rates; however, no data on the suppression of joint destruction have been obtained . At present, guselkumab is considered to be comparable with IL‐17 inhibitors; however, we must wait for the future investigation in phase III studies to draw this conclusion.…”

Section: Eligible Patients For Treatment With Biologicsmentioning

confidence: 99%

“…49 According to the results of a phase II study of guselkumab obtained to date, guselkumab has been shown to be superior to ustekinumab and to be approximately as effective as TNF inhibitors and IL-17 inhibitors based on the ACR response rates; however, no data on the suppression of joint destruction have been obtained. 58 At present, guselkumab is considered to be comparable with IL-17 inhibitors; however, we must wait for the future investigation in phase III studies to draw this conclusion. No studies on the evaluation of risankizumab for psoriatic arthritis based on the ACR response rates have been published; thus, the positioning of risankizumab in the treatment of psoriatic arthritis is unevaluable.…”

Section: Selection Criteria Of Biologicsmentioning

confidence: 99%

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Japanese guidance for use of biologics for psoriasis (the 2019 version)

Saeki

Terada

Morita

et al. 2020

The Journal of Dermatology

109

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As the first biologics for psoriasis in Japan, infliximab and adalimumab, anti‐tumor necrosis factor‐α antibodies, became available in the field of dermatology in 2010, followed by ustekinumab, an anti‐interleukin (IL)‐12/IL‐23p40 antibody, which was launched in Japan in 2011. Since 2015, three IL‐17 inhibitors of secukinumab and ixekizumab, anti‐IL‐17A antibodies, and brodalumab, an anti‐IL‐17 receptor antibody, and two anti‐IL‐23p19 antibodies of guselkumab and risankizumab, have also been launched. It is important for physicians to select appropriate biologic therapy for each psoriatic patient after due consideration of disease factors, treatment factors and patient background factors, sharing such information with patients. The following can be listed as points to be considered for the selection of biologics: drug effects (e.g. strength of effectiveness, time to onset of effectiveness, effectiveness against arthritis, primary failure, secondary failure), safety (e.g. infections, administration‐related reactions and relationships with other comorbidities), convenience for patients (e.g. hospital visit intervals, self‐injection, maintenance therapy at clinics, feasibility of drug discontinuation/re‐administration) and payment (medical costs) borne by patients. This guidance has been prepared with the aim of allowing dermatologists experienced in the treatment of psoriasis to use biologics appropriately according to the circumstances of individual patients after consideration of the above‐mentioned factors.

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Section: Eligible Patients For Treatment With Biologicsmentioning

confidence: 99%

Section: Selection Criteria Of Biologicsmentioning

confidence: 99%

Japanese guidance for use of biologics for psoriasis (the 2019 version)

Saeki

Terada

Morita

et al. 2020

The Journal of Dermatology

109

View full text Add to dashboard Cite

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“…Recent trials with anti-IL-23 agents have raised new questions about the pathogenesis of AS. Anti-IL-23 is beneficial for PsA (66) and the SpA-related diseases psoriasis and IBD (31,39). An open-labeled trial with an IL-12/IL-23 dual blocker initially suggested efficacy in AS (67), but a subsequent randomized control trial failed to achieve the primary target outcome (68).…”

Section: Ndi-031407 Controls Type 3 Immune Cell Activity With Systemimentioning

confidence: 99%

TYK2 inhibition reduces type 3 immunity and modifies disease progression in murine spondyloarthritis

Gracey

Hromadová

Lim

et al. 2020

Journal of Clinical Investigation

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“…Studies of IL-23p19 inhibitors in other indications, including ankylosing spondylitis, psoriatic arthritis and Crohn's disease, have also not identified any new or unexpected safety concerns. [53][54][55][56][57]…”

Section: Other Safety Datamentioning

confidence: 99%

Safety of selective IL‐23p19 inhibitors for the treatment of psoriasis

Crowley

Warren

Cather³

2019

Acad Dermatol Venereol

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Psoriasis is a chronic disease that requires long‐term treatment. Consequently, understanding the safety and tolerability of any potential treatment over time is critical to effective prescribing. The biologic agents currently available for the treatment of psoriasis target a number of different inflammatory cytokines involved in psoriasis disease pathogenesis. The monoclonal antibodies tildrakizumab, guselkumab and risankizumab target the p19 subunit that is specific to interleukin (IL)‐23. This article reviews published data on the safety of these IL‐23p19 inhibitors in patients with psoriasis compared with other currently available biologic therapies. Data from randomized, placebo‐ and active‐controlled phase 3 clinical trials show tildrakizumab, guselkumab and risankizumab to have a favourable risk–benefit profile in patients with moderate to severe psoriasis. No significant safety concerns have been observed for any of these IL‐23p19 inhibitors in the data published to date. The most commonly reported adverse events (AEs) associated with these agents in phase 3 studies were upper respiratory tract infections. No increase was seen in rates of serious infections, malignancies or major adverse cardiovascular events, with no signals suggestive of an elevated risk of opportunistic infections, active tuberculosis or reactivation of latent tuberculosis infection, mucocutaneous Candida infections, triggering or worsening of inflammatory bowel disease, demyelinating disorders or suicidal ideation. Selectively targeting IL‐23p19 may help avoid AEs that have been associated with biologic agents with other mechanisms of action. Data from long‐term extension studies and patient registries will further establish the safety profile of IL‐23p19 inhibitors for the treatment of moderate to severe psoriasis in routine practice.

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Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study

Cited by 160 publications

References 22 publications

Japanese guidance for use of biologics for psoriasis (the 2019 version)

Japanese guidance for use of biologics for psoriasis (the 2019 version)

TYK2 inhibition reduces type 3 immunity and modifies disease progression in murine spondyloarthritis

Safety of selective IL‐23p19 inhibitors for the treatment of psoriasis

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