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NICE guidance - Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

Authoring team

Guselkumab, alone or with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them, only if they have:

  • peripheral arthritis with 3 or more tender joints and 3 or more swollen joints
  • moderate to severe psoriasis (a body surface area of at least 3% affected by plaque psoriasis and a Psoriasis Area and Severity Index [PASI] score greater than 10)
  • had 2 conventional DMARDs and at least 1 biological DMARD

Assess the response to guselkumab from 16 weeks. Stop guselkumab at 24 weeks if psoriatic arthritis has not responded adequately using the Psoriatic Arthritis Response Criteria (PsARC; an adequate response is an improvement in at least 2 of the 4 criteria, 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria). If PsARC response does not justify continuing treatment but there is a PASI 75 response, a dermatologist should decide whether continuing treatment is appropriate based on skin response

Notes:

  • Guselkumab is an interleukin (IL)-23 inhibitor that binds to the p19 subunit of IL-23 that has been shown to be highly efficacious and well tolerated for the treatment of moderate-to-severe plaque psoriasis
    • during the initiation phase of the psoriatic skin lesions, there is an increment of the production of TNF occurs and, as a result, activation of dermal dendritic cells
      • these cells are responsible for the increased production of IL-23 and the subsequent activation of distinct subgroups of IL-17 producing cells
    • Guselkumab prevents the interaction of the IL-23 with its receptor on the surface of the cell
      • this action is responsible for blocking the initiation of the IL-23 pathway and the subsequent release of other proinflammatory cytokines
    • Guselkumab is the first in its class to be approved to treat moderate-to-severe plaque psoriasis
  • efficacy and safety of guselkumab in patients with active psoriatic arthritis were reported in two randomized, phase 3, multicenter, double-blind, placebo-controlled clinical trials (DISCOVER-1 and DISCOVER-2) that had as a primary endpoint of ACR20 response at week 24 (3,4)

Reference:

  • NICE (June 2021). Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs
  • Galluzzo M, Tofani L, Lombardo P, Petruzzellis A, Silvaggio D, Egan CG, Bianchi L, Talamonti M. Use of Guselkumab for the Treatment of Moderate-to-Severe Plaque Psoriasis: A 1 Year Real-Life Study. J Clin Med. 2020 Jul 9;9(7):2170.
  • Deodhar A, Helliwell PS, Boehncke WH, Kollmeier AP, Hsia EC, Subramanian RA, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNF alpha inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1115-25
  • Mease PJ, Rahman P, Gottlieb AB, Kollmeier AP, Hsia EC, Xu XL, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-36.

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