Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S).
Dermatol Ther (Heidelb). 2020 Aug; 10(4):663-670.DT

Abstract

INTRODUCTION

Patients with plaque psoriasis often have nail psoriasis, which is difficult to treat. Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis. We present post hoc data from a head-to-head trial of IXE and UST (IXORA-S) to examine the efficacy in nail psoriasis in patients with moderate-to-severe plaque psoriasis over 52 weeks.

METHODS

In IXORA-S, randomised patients received IXE (N = 136) or UST (N = 166) per label for 52 weeks. Eighty-four (61.8%) and 105 (63.3%) of the patients treated with IXE or UST, respectively, had baseline fingernail psoriasis (Nail Psoriasis Severity Index [NAPSI] > 0); of these, 54 (64.3%) and 63 (60.0%) patients, respectively, had significant baseline fingernail psoriasis (defined as NAPSI ≥ 16 with ≥ 4 fingernails involved). The proportion of patients achieving NAPSI = 0, a NAPSI score change from baseline and correlations in Psoriasis Area of Severity Index (PASI) and NAPSI improvement over 52 weeks were examined.

RESULTS

Progressive improvement occurred in both treatment groups over 52 weeks. Statistically significantly more patients achieved NAPSI = 0 with IXE versus UST by week 16-20, and the proportions continued to increase through week 52 among patients with baseline nail psoriasis (61.9 vs. 28.6%, respectively; P < 0.001), including those with significant nail psoriasis (57.4 vs. 17.5%, respectively; P < 0.001). Similar results were observed for NAPSI score improvement from baseline to week 52. Interestingly, the presence of nail psoriasis was associated with lower skin response with UST but not with IXE.

CONCLUSIONS

Ixekizumab was superior to UST in the clearance of nail psoriasis, with earlier improvement continued through 52 weeks regardless of baseline nail severity.

TRIAL REGISTRATION

ClinicalTrials.gov identifier; NCT02561806.

Links

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Authors+Show Affiliations

Wasel N

Stratica Medical and Probity Medical Research, Edmonton, AB, Canada. nwasel@straticamedical.com.

Thaçi D

Research Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.

French LE

Department of Dermatology and Allergy, University Hospital, Ludwig Maximilian University of Munich (LMU Munich), Munich, Germany.

Conrad C

Department of Dermatology, Lausanne University Hospital (CHUV), Lausanne, Switzerland.

Dutronc Y

Eli Lilly and Company, Indianapolis, IN, USA.

Gallo G

Eli Lilly and Company, Indianapolis, IN, USA.

Berggren L

HaaPACS GmbH, Schriesheim, Germany.

Lacour JP

Department of Dermatology, University Hospital of Nice-Côte d'Azur, Nice, France.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32415575

Clinical Trial Links

Clinical trial which this article describes

Citation

Wasel, Norman, et al. "Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients With Moderate-to-Severe Psoriasis: 52-Week Results From a Phase 3, Head-to-Head Study (IXORA-S)." Dermatology and Therapy, vol. 10, no. 4, 2020, pp. 663-670.

Wasel N, Thaçi D, French LE, et al. Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S). Dermatol Ther (Heidelb). 2020;10(4):663-670.

Wasel, N., Thaçi, D., French, L. E., Conrad, C., Dutronc, Y., Gallo, G., Berggren, L., & Lacour, J. P. (2020). Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S). Dermatology and Therapy, 10(4), 663-670. https://doi.org/10.1007/s13555-020-00383-x

Wasel N, et al. Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients With Moderate-to-Severe Psoriasis: 52-Week Results From a Phase 3, Head-to-Head Study (IXORA-S). Dermatol Ther (Heidelb). 2020;10(4):663-670. PubMed PMID: 32415575.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S). AU - Wasel,Norman, AU - Thaçi,Diamant, AU - French,Lars E, AU - Conrad,Curdin, AU - Dutronc,Yves, AU - Gallo,Gaia, AU - Berggren,Lovisa, AU - Lacour,Jean-Philippe, Y1 - 2020/05/15/ PY - 2020/3/5/received PY - 2020/5/18/pubmed PY - 2020/5/18/medline PY - 2020/5/17/entrez KW - Ixekizumab KW - Nail psoriasis KW - Psoriasis KW - Ustekinumab SP - 663 EP - 670 JF - Dermatology and therapy JO - Dermatol Ther (Heidelb) VL - 10 IS - 4 N2 - INTRODUCTION: Patients with plaque psoriasis often have nail psoriasis, which is difficult to treat. Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis. We present post hoc data from a head-to-head trial of IXE and UST (IXORA-S) to examine the efficacy in nail psoriasis in patients with moderate-to-severe plaque psoriasis over 52 weeks. METHODS: In IXORA-S, randomised patients received IXE (N = 136) or UST (N = 166) per label for 52 weeks. Eighty-four (61.8%) and 105 (63.3%) of the patients treated with IXE or UST, respectively, had baseline fingernail psoriasis (Nail Psoriasis Severity Index [NAPSI] > 0); of these, 54 (64.3%) and 63 (60.0%) patients, respectively, had significant baseline fingernail psoriasis (defined as NAPSI ≥ 16 with ≥ 4 fingernails involved). The proportion of patients achieving NAPSI = 0, a NAPSI score change from baseline and correlations in Psoriasis Area of Severity Index (PASI) and NAPSI improvement over 52 weeks were examined. RESULTS: Progressive improvement occurred in both treatment groups over 52 weeks. Statistically significantly more patients achieved NAPSI = 0 with IXE versus UST by week 16-20, and the proportions continued to increase through week 52 among patients with baseline nail psoriasis (61.9 vs. 28.6%, respectively; P < 0.001), including those with significant nail psoriasis (57.4 vs. 17.5%, respectively; P < 0.001). Similar results were observed for NAPSI score improvement from baseline to week 52. Interestingly, the presence of nail psoriasis was associated with lower skin response with UST but not with IXE. CONCLUSIONS: Ixekizumab was superior to UST in the clearance of nail psoriasis, with earlier improvement continued through 52 weeks regardless of baseline nail severity. TRIAL REGISTRATION: ClinicalTrials.gov identifier; NCT02561806. SN - 2193-8210 UR - https://www.unboundmedicine.com/medline/citation/32415575/Ixekizumab_and_Ustekinumab_Efficacy_in_Nail_Psoriasis_in_Patients_with_Moderate_to_Severe_Psoriasis:_52_Week_Results_from_a_Phase_3_Head_to_Head_Study__IXORA_S__ DB - PRIME DP - Unbound Medicine ER -

Tags

Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S).Dermatol Ther (Heidelb). 2020 Aug; 10(4):663-670.DT