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Original Investigation
April 15, 2020

Evaluation of Ixekizumab Treatment for Patients With Pityriasis Rubra Pilaris: A Single-Arm Trial

Author Affiliations
  • 1Department of Dermatology, Oregon Health & Science University, Portland, Oregon
  • 2Department of Dermatology, Yale University, New Haven, Connecticut
JAMA Dermatol. 2020;156(6):668-675. doi:10.1001/jamadermatol.2020.0932
Key Points

Question  Is ixekizumab an efficacious and safe treatment for moderate to severe pityriasis rubra pilaris?

Findings  In this single-arm trial that included 12 adults, 7 achieved a 50% or greater reduction in clinical severity as measured by the Psoriasis Area and Severity Index, and there was a reduction in mean Dermatology Life Quality Index, itch, and pain scores. No serious or unexpected adverse events were observed.

Meaning  Ixekizumab was associated with decreased clinical signs and symptoms of pityriasis rubra pilaris and no serious adverse events.

Abstract

Importance  Pityriasis rubra pilaris is a rare and disabling cutaneous disease that is frequently recalcitrant to conventional therapies and appears to involve interleukin (IL)-17 overexpression.

Objective  To investigate the clinical response and safety of ixekizumab in treating pityriasis rubra pilaris.

Design, Setting, and Participants  Single-arm, investigator-initiated trial conducted in adult patients with moderate to severe pityriasis rubra pilaris at a single-center academic university from June 2018 to January 2020. A total of 41 patients were screened, 12 were enrolled, and 11 completed the full duration of therapy. A referred, consecutive sample was used during participant selection. The treatment period and primary outcome occurred over 24 weeks with additional patient follow-up through 36 weeks.

Intervention  Subcutaneous administration of ixekizumab, a humanized IgG4 antibody that binds IL-17A, at the US Food and Drug Administration–approved dosing schedule for treatment of psoriasis for 24 weeks.

Main Outcomes and Measures  The primary outcome was the mean change in Psoriasis Area and Severity Index at 24 weeks. Secondary outcomes included change in affected body surface area, quality of life, induction of sustained remission, and association of improvement with CARD14 genetic variations and cutaneous cytokine expression.

Results  A total of 12 white patients (mean [SD] age, 49.8 [15.1] years; 8 male [67%]) were enrolled between June 2018 and April 2019, with 11 completing the full course of intervention. The mean (SEM) improvements in Psoriasis Area and Severity Index, affected body surface area, and Dermatology Life Quality Index were 15.2 (2.1) (P < .0001), 29.8% (9.3%) (P = .009), and 9.5 (2.5) (P = .004), respectively. The 4 participants with the most improvement in Psoriasis Area and Severity Index at week 24 stayed in remission at week 36 (defined as lack of increase in Psoriasis Area and Severity Index from week 24 through week 36), off therapy. Relative dermal IL-17A expression decreased by a 1.9 log-fold change. No participants had known pathogenic CARD14 variations. There were no serious adverse events.

Conclusions and Relevance  In this single-armed trial, ixekizumab was associated with reduced clinical signs and symptoms of pityriasis rubra pilaris in a subset of patients, including those in whom other systemic therapies have failed.

Trial Registration  ClinicalTrials.gov Identifier: NCT03485976

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