Roflumilast tópico y oral en dermatología. Una revisión narrativa

Mansilla-Polo, M.; Gimeno, E.; Morgado-Carrasco, D.

doi:10.1016/j.ad.2023.09.005

Cited by 3 publications

(1 citation statement)

References 55 publications

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“…Improvements in HS lesions were observed (IHS4‐score = 6) after 5 months treatment 23 . Topical roflumilast has been approved for psoriasis and mild‐to‐moderate seborrheic dermatitis 24 . Oral apremilast is approved for psoriasis, psoriasis arthritis and oral aphthous stomatitis in Bechet's disease 25…”

Section: Discussionmentioning

confidence: 99%

Orismilast for the treatment of mild to severe hidradenitis suppurativa: Week 16 data from OSIRIS, a Phase 2a, open‐label, single‐centre, single‐arm, dose‐finding clinical trial

Frederiksen,

Sedeh,

Taudorf

et al. 2023

Acad Dermatol Venereol

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BackgroundHidradenitis suppurativa (HS) is a disease with an unmet need for treatment.ObjectiveTo examine tolerability, safety and efficacy of oral phosphodiesterase‐4 (PDE4) inhibitior orismilast 10–40 mg twice daily (BID) in HS.MethodsA Phase 2a, single‐arm, single‐centre, open‐label, 16‐week trial in HS patients. Adjustments in maximal dose and titration were allowed, to improve tolerability, dividing the study population in two groups who completed and discontinued 16 weeks of treatment.Descriptive statistics were applied to efficacy data from patients who completed treatment and patients who discontinued treatment prematurely. A last‐observation‐carried‐forward (LOCF) approach was used for patients who discontinued treatment.The primary endpoint was percent change in the total number of abscesses and nodules (AN‐count) at Week 16, with the HS Clinical Response with a 50% reduction in the AN‐count (HiSCR50) as key secondary endpoint.ResultsOf the 20 patients included, 9 completed 16 weeks of treatment and 11 discontinued treatment prematurely. The mean AN‐count was reduced with 33.1% in patients who completed treatment and with 12.0% in patients who discontinued. HiSCR50 was achieved by 67.0% and 27.0% of patients who completed and discontinued treatment, respectively. Most adverse events were mild to moderate.ConclusionsOral orismilast demonstrated a dose‐dependent tolerability, with mild to moderate adverse effects. Further, the results of this exploratory trial indicate that orismilast may lead to clinical improvements in HS. However, larger trials with tolerable dose ranges are warranted.The Trial is registered at Clinicaltrials.gov (UNI50007201) and EudraCT.ema.europa.eu (2021‐000049‐42).

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Section: Discussionmentioning

confidence: 99%