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Introduction to dermatological treatment
Published in Richard Ashton, Barbara Leppard, Differential Diagnosis in Dermatology, 2021
Richard Ashton, Barbara Leppard
Ustekinumab (Stelara), is directed against interleukin 12 and 23 but should be used with caution in patients with a history of malignancy. The IL-23 inhibitors, such as Guselkumab and Risankizumab are very convenient as they only need to be given every 12 weeks. No specific adverse reactions have been reported with the IL-23 inhibitors.
Targeting IL-23/IL-17 Axis for Treatment of Psoriasis and Psoriatic Arthritis
Published in Siba P. Raychaudhuri, Smriti K. Raychaudhuri, Debasis Bagchi, Psoriasis and Psoriatic Arthritis, 2017
Subhashis Banerjee, Philip Mease
Risankizumab (BI 655066) is another antibody to IL-23 p19 that has been evaluated in psoriasis. It was tested in a small Phase 1 proof-of-concept study (n = 39) where patients with psoriasis achieved PASI 75 and PASI 90 at rates of 87% and 58% with a single intravenous or subcutaneous dose. Further, six of eight patients enrolled in an extension period maintained PASI 100 results over 66 weeks with that single dose [27].
Biologic therapies in the pipeline
Published in M. Alan Menter, Caitriona Ryan, Psoriasis, 2017
Molly Campa, Pablo Michel, Caitriona Ryan
Risankizumab (Boehringer Ingelheim, Ingelheim am Rhein, Germany), a fully human IgG1 monoclonal antibody specific for the IL-23 p19 subunit, is in development for moderate-to-severe psoriasis and other inflammatory diseases.12 Phase II clinical trial data comparing the efficacy and safety of risankizumab to ustekinumab demonstrated the superiority of risankizumab over ustekinumab with a PASI 90 response achieved in 77.1% of patients in the risankizumab group versus 40% of patients in the ustekinumab group (p < .0001).12 Several phase III studies are currently ongoing for psoriasis and psoriatic arthritis, including studies comparing risankizumab to ustekinumab and adalimumab.13–17
Comparison of psoriasis guidelines for use of IL-23 inhibitors in the United States and United Kingdom: a critical appraisal and comprehensive review
Published in Journal of Dermatological Treatment, 2022
R. I. Ghamrawi, N. Ghiam, J. J. Wu
The FDA-approved dosing for risankizumab is 150 mg subcutaneous injection at weeks 0 and 4 followed by maintenance dosing every 12 weeks thereafter (6). Due to the release of joint AAD-NPF guidelines prior to risankizumab’s FDA approval, the dosage of risankizumab is not outlined. However, the guidelines do address risankizumab’s efficacy in phase II and III trials. In an RCT of 166 patients, participants were randomized to receive either risankizumab (18 mg at week 0 or 90 mg or 180 mg at weeks 0, 4, and 16) or ustekinumab (45 mg or 90 mg at weeks 0, 4, and 16). A greater proportion of patients receiving either risankizumab dosage (77%) achieved PASI 90 at week 12 compared to the ustekinumab group (40%; p < .001) (22). Risankizumab has also been compared with ustekinumab in the UltIMMa-1 and UltIMMa-2 trials and with adalimumab in the IMMvent trial. In each of these RCTs, risankizumab proved more effective than ustekinumab in achieving PASI 90, a primary endpoint, at week 16 (UltIMMA-1: PASI 90 rates of 75.3% vs. 42.0%, respectively; p < .001) (23) and adalimumab (IMMvent: PASI 90 rates of 72.4% vs 47.4% respectively; p < .001) (24). NICE guidelines recommend the discontinuation of risankizumab at 16 weeks if adequate response remains unachieved. As with guselkumab and tildrakizumab, adequate response is defined by achievement of PASI 75 or by PASI 50 and a five-point reduction in DLQI (10).
IL-23 inhibition for the treatment of psoriatic arthritis
Published in Expert Opinion on Biological Therapy, 2022
Raagav Mohanakrishnan, Secia Beier, Atul Deodhar
Risankizumab is a monoclonal antibody targeting the p19 subunit of IL-23 that is approved for the treatment of severe psoriasis [46]. Risankizumab has been shown to be effective in treating PsA when compared to placebo in a Phase 2 study. Patients were followed for a total of 32 weeks, and assessments completed at 24 weeks showed significantly better ACR20, ACR50, ACR70, PASI, DAS-28 responses compared to placebo [47]. Tildrakizumab is another IL-23p-19 inhibitor approved for the treatment of severe psoriasis and under evaluation for treatment of PsA [48]. Phase 2 studies of Tildrakizumab have showed significant improvements in ACR20, ACR50, and ACR70 when compared to placebo. Phase 3 trials are currently underway to further evaluate Risankizumab and Tildrakizumab as treatment options for PsA [49]. Data from the KEEPsAKE-1 and KEEPsAKE-2 phase 3 studies have thus far shown a positive ACR20 response at 24 weeks when compared to placebo. Full results from the studies are still pending release.
An economic evaluation of risankizumab versus other biologic treatments of moderate to severe plaque psoriasis in Japan
Published in Journal of Dermatological Treatment, 2022
Hidehisa Saeki, Kanako Ishii, Avani Joshi, Arielle G. Bensimon, Hongbo Yang, Isao Kawaguchi
Risankizumab is a fully humanized monoclonal antibody with a high affinity for the p19 component of IL-23, a cytokine that contributes directly to the pathogenesis of psoriasis (13). Data from four large, multi-national, phase 3 randomized controlled trials (UltIMMa-1/NCT02684370, UltIMMa-2/NCT02684357, IMMvent/NCT02694523, and IMMhance/NCT02672852) showed significantly greater efficacy with risankizumab versus placebo (14–16), ustekinumab (14), and adalimumab (15) as measured by relative improvements from baseline in the Psoriasis Area and Severity Index (PASI). Across the trials, 72.4–75.3% of patients randomized to risankizumab achieved ≥90% improvement in PASI (i.e. PASI 90) at week 16 (14–16), with 75.7–81.9% achieving PASI 90 following longer-term maintenance therapy with risankizumab at week 44 (15) or 52 (14). Risankizumab is the latest anti-IL-23 biologic approved in Japan (approval date: March 26, 2019) for the treatment of psoriasis in patients who have not responded sufficiently to conventional therapies (17).