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Clinical Trial
. 2020 Jan 7;100(1):adv00006.
doi: 10.2340/00015555-3353.

Ixekizumab Results in Persistent Clinical Improvement in Moderate-to-Severe Genital Psoriasis During a 52 Week, Randomized, Placebo-Controlled, Phase 3 Clinical Trial

Lyn Guenther  1 , Alison Potts Bleakman, Jamie Weisman, Yves Poulin, Lynda Spelman, Russel Burge, Janelle Erickson, Kristin Todd, Clinton C Bertram, Caitriona Ryan
Affiliations
Clinical Trial

Ixekizumab Results in Persistent Clinical Improvement in Moderate-to-Severe Genital Psoriasis During a 52 Week, Randomized, Placebo-Controlled, Phase 3 Clinical Trial

Lyn Guenther et al. Acta Derm Venereol. .

Abstract

Ixekizumab was efficacious in treating moderate-to-severe genital psoriasis over 12 weeks. We evaluated the long-term efficacy and safety of ixekizumab for up to 52 weeks. Patients were randomized to 80 mg ixekizumab every 2 weeks or to placebo through Week 12, then received 80 mg open-label ixekizumab every 4 weeks through Week 52. In patients initially randomized to ixekizumab, clear or almost clear genital skin was achieved for 73% of patients at Week 12 and 75% at Week 52. Persistent improvements were also observed for overall psoriasis, genital itch, and the impact of genital psoriasis on the frequency of sexual activity. The safety profile was consistent with studies of ixekizumab in patients with moderate-to-severe plaque psoriasis. Ixekizumab provided rapid and persistent improvements in the signs and symptoms of genital psoriasis for up to 52 weeks of treatment.

Keywords: IXORA-Q; clinical trial; genital psoriasis; itch; ixekizumab; sexual impact.

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Conflict of interest statement

Conflicts of interest: LG has been a consultant, investigator, and speaker for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, Leo Pharma, Merck, and Pfizer; has been a speaker and consultant for Valeant and Tribute; and has been an investigator for UCB. JW has been an investigator for AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, GlaxoSmithKline, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Stiefel, and Valeant; has been a speaker and served on an advisory board for AbbVie, Eli Lilly and Company, and Janssen. YP has received grant funding or honoraria for services as an investigator, speaker, or member of advisory boards from: AbbVie, Amgen, and Janssen, and has received grant funding for services as an investigator for: Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermira, Eli Lilly and Company, Galderma, GlaxoSmithKline, Leo Pharma, MedImmune, Merck, Novartis, Pfizer, Serono, and UCB. LS has served on an advisory board for AbbVie, Eli Lilly and Company, Novartis, and Sanofi and has been an investigator for AbbVie, Amgen, Ascend Biopharma, Australian Wool Innovation Limited, Celgene, Dermira, Eli Lilly and Company, Galderma, Genentech, GlaxoSmithKline, Leo Pharma, Merck, Novartis, Otsuka, Pfizer, Phosphagenics, Regeneron, and UCB. CR has been a consultant, advisor, and /or speaker for Abb-Vie, Boehringer Ingelheim, Dermira, Dr. Reddy’s Laboratories, Eli Lilly and Company, Janssen, Leo Pharma, Medimetriks, Novartis, and UCB. APB, RB, JE, KT, and CCB, are employees and own stock in Eli Lilly and Company.

Data sharing statement. Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org.

Figures

Fig. 1
Fig. 1
Genital psoriasis severity during 52 weeks (NRI) of treatment in IXORA-Q. (a) Proportion of patients achieving a static Physician’s Global Assessment of Genitalia (sPGA-G) score of 0 or 1 at each post-baseline visit. (b) Proportion of patients achieving complete resolution of genital psoriasis (sPGA-G 0) at each post-baseline visit. (c) Proportion of patients achieving a sPGA-G 0/1 at Week 52 among patients with lower (1 to <10%) and higher (≥10%) body surface area involvement at baseline. (d) Proportion of patients achieving at least a 2-point improvement in the Patient’s Global Assessment of Genital Psoriasis among patients with a baseline score of ≥2. (a-d) Results are summarized for the placebo (PBO) population (all patients randomized to placebo at Week 0) through Week 12, the PBO/IXE Q4W population (all patients randomized to placebo at Week 0 who entered the open-label treatment period and received at least 1 dose of ixekizumab) from Weeks 12 to 52, and the IXE population (all patients randomized to ixekizumab at Week 0) through Week 52.
Fig. 2
Fig. 2
Overall psoriasis during 52 weeks of treatment (nonresponder imputation) in IXORA-Q. (a) Proportion of patients achieving an overall static Physician’s Global Assessment (sPGA) score of 0 or 1 at each post-baseline visit. (b) Proportion of patients achieving complete resolution of overall psoriasis (sPGA 0) at each post-baseline visit. (a and b) Results are summarized for the PBO population (all patients randomized to placebo at Week 0) through Week 12, the PBO/IXE Q4W population (all patients randomized to placebo at Week 0 who entered the open-label treatment period and received at least one dose of ixekizumab) from Weeks 12 to 52, and IXE population (all patients randomized to ixekizumab at Week 0) through Week 52.
Fig. 3
Fig. 3
Photographic examples of improvement in genital psoriasis during 52 weeks of treatment in IXORA-Q. (a) Photographs of the genital region of a female patient in the PBO/IXE Q4W population. (b) Photographs of the genital region of a male patient in the IXE population.
Fig. 4
Fig. 4
Patient-reported outcomes during 52 weeks (nonresponder imputation) of treatment in IXORA-Q. (a) Proportion of patients achieving at least a 3-point improvement in the genital itch numeric rating scale (NRS) at each post-baseline visit among patients with a score of ≥3 at baseline. (b) Proportion of patients achieving at least a 4-point improvement in the genital itch NRS at each post-baseline visit among patients with a score of ≥4 at baseline. (c) Proportion of patients achieving a score of 0 or 1 in the genital psoriasis Sexual Frequency Questionnaire Item 2 (GenPs-SFQ Item 2), indicating genital psoriasis never or rarely limited the frequency of sexual activity, among patients with a score of ≥2 at baseline. (a-c) Results are summarized for the PBO population (all patients randomized to placebo at Week 0) through Week 12, the PBO/IXE Q4W population (all patients randomized to placebo at Week 0 who entered the open-label treatment period and received at least 1 dose of ixekizumab) from Weeks 12 to 52, and IXE population (all patients randomized to ixekizumab at Week 0) through Week 52.
See this image and copyright information in PMC

References

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