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SPESOLIMAB MEETS PHASE 2B ENDPOINTS FOR PREVENTION OF GPP FLARES

Spesolimab (Spevigo, Boehringer Ingelheim), an antiinterleukin-36 receptor antibody, met its primary and key secondary endpoints, demonstrating it can prevent flares in patients with generalized pustular psoriasis (GPP) and provide sustained symptom management for up to 48 weeks, according to results of the phase 2b Effisayil 2 trial.1,2 Safety data were in line with previously conducted clinical trials with spesolimab.

The Effisayil 1 trial demonstrated rapid and sustained pustular and skin clearance in adult patients with flaring GPP treated with spesolimab, according to Boehringer Ingelheim. The Effisayil 1 trial results supported the recent approval of spesolimab as the first specific treatment for GPP flares in adults in major markets, including the United States, Japan, Mainland China, and the European Union.

GPP is a rare and unpredictable systemic skin disease that is distinct from plaque psoriasis in both its disease mechanism and severity. Spesolimab is the first approved treatment to specifically target the interleukin-36 pathway for the treatment of GPP flares that has been evaluated in a statistically powered, randomized, placebo-controlled trial. Further spesolimab data are expected later this year, including the final Effisayil 2 results investigating the prevention of GPP flares. Spesolimab is also under investigation for the treatment of other interleukin-36–mediated skin diseases.3

1. Morita A, Choon SE, Bachelez H, et al. Design of Effisayil 2: a randomized, double-blind, placebo-controlled study of spesolimab in preventing flares in patients with generalized pustular psoriasis. Dermatol Ther (Heidelb). 2023;13(1):347-359.

2. A study to test whether BI 655130 (spesolimab) prevents flare-ups in patients with generalized pustular psoriasis. US National Library of Medicine. Updated December 30, 2022. Accessed February 4, 2023. www.clinicaltrials.gov/ct2/show/study/NCT04399837?term=Boehringer

3. A study to test whether spesolimab helps people with a skin disease called hidradenitis suppurativa. US National Library of Medicine. Updated September 16, 2021. Accessed February 4, 2023. https://clinicaltrials.gov/ct2/show/NCT04762277

EUROPEAN MEDICINES AGENCY RECOMMENDS APPROVAL OF ONCE-DAILY SOTYKTU

Four months after deucravacitinib (Sotyktu, Bristol Myers Squibb) received FDA approval, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of the medication for the treatment of adults with moderate to severe plaque psoriasis. The CHMP recommendation will now be reviewed by the European Commission.

Deucravacitinib, an oral medication taken once daily, is a first-in-class, selective, allosteric tyrosine kinase 2 inhibitor for the treatment of adults who are candidates for systemic therapy. The CHMP adopted the opinion based on results from the pivotal phase 3 POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once-daily deucravacitinib in patients with moderate to severe plaque psoriasis versus placebo and twice-daily apremilast (Otezla, Amgen) as well as an additional 2 years of data from the POETYK PSO long-term extension trial. Deucravacitinib demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden, and quality of life measures compared to placebo and apremilast. Deucravacitinib was well tolerated with a low rate of discontinuation due to adverse events. The most common adverse reactions (≥ 1% of patients on deucravacitinib) included upper respiratory infections, herpes simplex infections, oral ulcers, folliculitis, and acneiform rash. The results of the phase 3 POETYK PSO-1 and POETYK PSO-2 trials were published in the Journal of the American Academy of Dermatology.1,2

1. Armstrong AW, Gooderham M, Warren RB, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. J Am Acad Dermatol. 2023;88(1):29-39.

2. Strober B, Thaçi D, Sofen H, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 program for evaluation of TYK2 inhibitor psoriasis second trial. J Am Acad Dermatol. 2023;88(1):40-51.

ROFLUMILAST CREAM SHOWS SUSTAINED EFFICACY IN PHASE 2B STUDY

Roflumilast cream 0.3% (Zoryve, Arcutis) showed sustained efficacy with clearance for a median of 10 months in adults with chronic plaque psoriasis, according to a phase 2, open-label, long-term safety study presented at the Winter Clinical dermatology meeting. The once-daily steroid-free topical phosphodiesterase-4 inhibitor was approved by the FDA in July 2022.

During the trial, 57.1% (n = 185) of patients treated with roflumilast cream achieved an Investigator Global Assessment (IGA) score of clear or almost clear (IGA 0/1) at any time.1 The participants had a median duration of IGA of 0/1 of more than 10 months (40.1 weeks). IGA success was achieved by 35.3% of participants previously treated with roflumilast cream and 37.5% of roflumilast-naïve participants. IGA success was defined as clear/almost clear with a 2-grade improvement from baseline. In addition, 42% of participants previously treated with roflumilast cream and 47.5% of roflumilast-naïve participants achieved an IGA score of 0/1 at week 52, the study showed.1

Close to 67% of participants in cohort-2 achieved intertriginous-IGA success, defined as clear or almost clear with a 2-grade improvement from baseline. No tachyphylaxis occurred, and efficacy was consistent over time among participants who achieved an IGA of 0/1. There was a low discontinuation rate due to adverse events, and at least 97% of patients showed no irritation, according to a company news release.1

1. Arcutis presents new phase 2 long-term data showing sustained efficacy and clearance for a median of 10 months with roflumilast cream in adults with chronic plaque psoriasis. News release. Arcutis. January 14, 2023. Accessed February 7, 2023. www.arcutis.com/arcutis-presents-new-phase-2-long-term-data-showing-sustained-efficacy-and-clearance-for-a-median-of-10-months-with-roflumilast-cream-in-adults-with-chronic-plaque-psoriasis

FIRST PATIENT DOSED IN PHASE 2 CLINICAL TRIAL OF TLL018-205

The first patient has been enrolled and dosed in a phase 2 study evaluating the efficacy and safety of TLL-018 for moderate to severe plaque psoriasis. The study is sponsored by Hangzhou Highlightll Pharmaceutical. TLL-018 is a novel, highly potent, and selective inhibitor of TYK2 and JAK1, which are the key regulators of proinflammatory cytokines.1

1. Vial announces enrollment of first patient in phase II clinical trial TLL018-205 for the treatment of plaque psoriasis sponsored by Highlightll Pharmaceutical. News release. January 19, 2023. Accessed February 7, 2023. vial.com/blog/pr/vial-announces-enrollment-of-first-patient-in-phase-ii-clinical-trial-tll018-205

PHASE 3 TRIAL SHOWS EQUIVALENCE BETWEEN DMB-3115 AND USTEKINUMAB

Dong-A ST announced that therapeutic equivalence and safety were established between DMB-3115 and the reference drug ustekinumab (Stelara, Janssen Biotech) in global phase 3 trials.1 Initiated in 2021, the randomized, double-blinded, multicenter, parallel, active-control study enrolled 605 patients over 52 weeks in the United States and eight European countries.2 Patients with moderate to severe chronic plaque psoriasis were treated with DMB-3115 or ustekinumab to compare efficacy, safety, and immunogenicity. In accordance with the recommendation from the regulatory agencies, primary endpoint time frames were set at weeks 8 and 12 for the European Medicines Agency and the FDA, respectively.2

DMB-3115 and ustekinumab demonstrated therapeutic equivalence when looking at percent change from baseline in Psoriasis Area and Severity Index at weeks 8 and 12. There was no clinically significant difference in safety, according to Dong-A ST.1

1. Efficacy, safety, and immunogenicity of subcutaneous DMB-3115 versus Stelara in patients with moderate to severe chronic plaque psoriasis (Opportuniti). US National Library of Medicine. Updated November 21, 2022. Accessed February 7, 2023. clinicaltrials.gov/ct2/show/NCT04785326

2. Dong-A ST: phase 3 trial shows therapeutic equivalence between plaque psoriasis drug candidate DMB-3115 and Stelara. News release. January 17, 2023. Accessed February 7, 2023. https://practicaldermatology.com/news/dong-a-st-demonstrates-therapeutic-equivalence-between-plaque-psoriasis-drug-candidate-dmb-3115-and-stelara-in-phase-3-trial

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