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Review
. 2023 Oct;10(5):1127-1146.
doi: 10.1007/s40744-023-00553-1. Epub 2023 Jul 3.

A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis

Bruce W Kirkham  1 , Alexander Egeberg  2   3 , Frank Behrens  4 , Andreas Pinter  5 , Joseph F Merola  6 , Thorsten Holzkämper  7 , Gaia Gallo  7 , Khai Jing Ng  7 , Rebecca Bolce  7 , Christopher Schuster  7   8 , Peter Nash  9   10 , Luis Puig  11
Affiliations
Review

A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis

Bruce W Kirkham et al. Rheumatol Ther. 2023 Oct.

Abstract

Nail psoriasis is a difficult-to-treat manifestation of psoriatic disease affecting up to 80% of patients with psoriatic arthritis (PsA) and 40-60% of patients with plaque psoriasis (PsO). Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for the treatment of patients with PsA and patients with moderate-to-severe PsO. This narrative review aims to summarize nail psoriasis data generated from IXE clinical trials in patients with PsA (SPIRIT-P1, SPIRIT-P2, and SPIRIT-H2H) and/or moderate-to-severe PsO (UNCOVER-1, -2, -3, IXORA-R, IXORA-S, and IXORA-PEDS) with an emphasis on head-to-head clinical trial data. Across numerous trials explored, IXE treatment was associated with greater improvement in resolution of nail disease versus comparators at week 24, results which were maintained up to and beyond week 52. Additionally, patients experienced higher rates of resolution of nail disease versus comparators at week 24 and maintained high levels of resolution up to week 52 and beyond. In both PsA and PsO, IXE demonstrated efficacy in treating nail psoriasis, and therefore may be an effective therapy option. Trial Registration: ClinicalTrials.gov identifier UNCOVER-1 (NCT01474512), UNCOVER-2 (NCT01597245), UNCOVER-3 (NCT01646177), IXORA-PEDS (NCT03073200), IXORA-S (NCT02561806), IXORA-R (NCT03573323), SPIRIT-P1 (NCT01695239), SPIRIT-P2 (NCT02349295), SPIRIT-H2H (NCT03151551).

Keywords: Ixekizumab; Nail psoriasis; Plaque psoriasis; Psoriatic arthritis.

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Conflict of interest statement

Andreas Pinter has been an investigator and/or speaker and/or advisor for AbbVie, Almirall-Hermal, Amgen, Biogen Idec, Biontec, Boehringer-Ingelheim, Celgene, GSK, Eli Lilly and Company, Galderma, Hexal, Janssen, LEO-Pharma, MC2, Medac, Merck Serono, Mitsubishi, MSD, Novartis, Pascoe, Pfizer, Tigercat Pharma, Regeneron, Roche, Sandoz Biopharmaceuticals, Sanofi-Genzyme, Schering-Plough und UCB Pharma. Frank Behrens has been an adviser and/or received speakers’ honoraria and/or received grants for AbbVie, Pfizer, Roche, Chugai, Prophylix, Novartis, Iron4U, UCB, BMS, Celgene, MSD, Novartis, Biotest, Janssen, Genzyme, Sanofi, Eli Lilly and Company, Sandoz, Boehringer Ingelheim. Alexander Egeberg has received research funding from Pfizer, Eli Lilly and Company, Novartis, AbbVie, Janssen Pharmaceuticals, the Danish National Psoriasis Foundation, and the Kgl Hofbundtmager Aage Bang Foundation, and honoraria as consultant and/or speaker from AbbVie, Almirall, Leo Pharma, Samsung Bioepis Co., Ltd., Pfizer, Eli Lilly and Company, Novartis, Galderma, Dermavant, UCB, Mylan, Bristol-Myers Squibb, Sun Therapeutics, Galápagos NV, Union Therapeutics, and Janssen Pharmaceuticals. Joseph F. Merola is a consultant and/or investigator for Amgen, Bristol-Myers Squibb, AbbVie, Dermavant, Eli Lilly and Company, Novartis, Janssen, UCB, Sanofi-Regeneron, Sun Pharma, Biogen, Pfizer and Leo Pharma. Peter Nash is a consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, Roche, Sanofi, and UCB, is on the speakers bureau of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, Roche, Sanofi, and UCB, and has received research funding from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, Roche, Sanofi, and UCB. Thorsten Holzkämper, Gaia Gallo, Khai Jing Ng, Rebecca Bolce, and Christopher Schuster are employees and shareholders of Eli Lilly and Company. Luis Puig has received consulting fees and/or grants and/or speakers’ Honoraria from AbbVie, Almirall, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Fresenius-Kabi, Janssen, JS BIOCAD, Leo-Pharma, Eli Lilly and Company, Mylan, Novartis, Pfizer, Regeneron, Roche, Sandoz, Samsung-Bioepis, Sanofi, UCB. Bruce W. Kirkham. has received speaker’s payments from AbbVie, Eli Lilly and Company, Galapagos, Janssen, Novartis, Pfizer, and UCB. B. W. has received research support from AbbVie, Eli Lilly and Company, and Novartis. B. W. has been an adviser for AbbVie, Eli Lilly and Company, Galapagos, Janssen, Novartis, Pfizer, and UCB.

Figures

Fig. 1
Fig. 1
Summary of nail psoriasis data across IXE trials in patients with PsO with concomitant nail psoriasis at baseline. Note: Where available, additional IXE Q2W data are included in supplemental figure 1. aIn IXORA-S and IXORA-R, patients received IXE Q2W for the first 12 weeks of treatment before switching to IXE Q4W. IXE ixekizumab, IXE Q4W ixekizumab every 4 weeks, IXE Q2W ixekizumab every 2 weeks, PsO plaque psoriasis, NP nail psoriasis, ETN etanercept, PBO placebo, UST ustekinumab, GUS guselkumab, NAPSI Nail Psoriasis Severity Index. *p < 0.05, **p < 0.01, ***p < 0.001, and ****p < 0.0001 significant versus comparator
Fig. 2
Fig. 2
Summary of nail psoriasis data across IXE trials in patients with PsA with concomitant nail psoriasis at baseline (NAPSI > 0). Note: At 52 weeks, only extension period population nail psoriasis data has been reported, therefore only the extension period population data has been presented at this timepoint. Only IXE Q4W data have been included here. Where available, IXE Q2W data are included in supplemental figure 2. IXE ixekizumab, IXE Q4W ixekizumab every 2 weeks, IXE Q2W ixekizumab every 2 weeks, NP nail psoriasis, PsA psoriatic arthritis, PBO placebo, ADA adalimumab, NAPSI Nail Psoriasis Severity Index. *p < 0.05, **p < 0.01, ***p < 0.001, and ****p < 0.0001 significant versus comparator
See this image and copyright information in PMC

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