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Efficacy and Safety of Ixekizumab Versus Adalimumab in Biologic-naïve Patients With Active Psoriatic Arthritis and Moderate-to-severe Psoriasis: 52-week Results From the Randomized SPIRIT-H2H Trial.
Dermatol Pract Concept. 2022 May; 12(2):e2022104.DP

Abstract

Introduction

The randomized, open-label, assessor-blinded, parallel-group SPIRIT-H2H trial (NCT03151551) demonstrated superiority of ixekizumab over adalimumab in simultaneously achieving improvement in joint symptoms (American College of Rheumatology [ACR]50) and skin clearance (Psoriasis Area and Severity Index [PASI]100) in biologic-naïve patients with active psoriatic arthritis (PsA) and plaque psoriasis (PsO) at Week (W) 24. Higher efficacy of ixekizumab versus adalimumab was maintained through W52.

Objectives

This analysis investigated efficacy and safety of ixekizumab and adalimumab in the subgroup of patients with PsA and moderate-to-severe PsO through W52.

Methods

Efficacy and safety outcomes were analyzed in patients with PsA and moderate-to-severe PsO (PASI ≥ 12, Body Surface Area ≥ 10%, static Physician Global Assessment ≥ 3) through W52. Categorical and continuous outcomes were analyzed using logistic regression models and mixed model for repeated measures, respectively.

Results

More ixekizumab-versus adalimumab-treated patients simultaneously achieved PASI100 and ACR50 at W24 (40.8% versus 17.6%, P = 0.015) and W52 (38.8% versus 17.6%, P = 0.026). Likewise, more ixekizumab-versus adalimumab-treated patients achieved PASI100 (59.2% versus 25.5%, P = 0.001) and PASI90 (81.6% versus 60.8%, P = 0.028) through W52, and nail PsO clearance at W24. Joint symptom improvements were comparable between groups. No new safety findings were reported.

Conclusions

Ixekizumab had higher efficacy than adalimumab in simultaneous achievement of ACR50 and PASI100 at W24 and W52 in patients with PsA and moderate-to-severe PsO. Ixekizumab-treated patients showed higher response rates for nail PsO clearance and for reporting minimal or no impact on quality of life at W24.

Links

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Authors+Show Affiliations

Reich K
Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Kristensen LE
Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
Smith SD
The Dermatology and Skin Cancer Centre, St Leonards, and Discipline of Dermatology, Sydney Medical School, University of Sydney, Sydney, Australia.
Rich P
Oregon Dermatology and Research, Portland, Oregon, USA.
Sapin C
Eli Lilly and Company, Indianapolis, Indiana, USA.
Leage SL
Eli Lilly and Company, Indianapolis, Indiana, USA.
McKenzie R
Eli Lilly and Company, Indianapolis, Indiana, USA.
Schuster C
Eli Lilly and Company, Indianapolis, Indiana, USA. Department of Dermatology, Medical University of Vienna, Vienna, Austria.
Riedl E
Eli Lilly and Company, Indianapolis, Indiana, USA. Department of Dermatology, Medical University of Vienna, Vienna, Austria.
Gooderham M
SKiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough, Ontario, Canada.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

35646453

Citation

Reich, Kristian, et al. "Efficacy and Safety of Ixekizumab Versus Adalimumab in Biologic-naïve Patients With Active Psoriatic Arthritis and Moderate-to-severe Psoriasis: 52-week Results From the Randomized SPIRIT-H2H Trial." Dermatology Practical & Conceptual, vol. 12, no. 2, 2022, pp. e2022104.
Reich K, Kristensen LE, Smith SD, et al. Efficacy and Safety of Ixekizumab Versus Adalimumab in Biologic-naïve Patients With Active Psoriatic Arthritis and Moderate-to-severe Psoriasis: 52-week Results From the Randomized SPIRIT-H2H Trial. Dermatol Pract Concept. 2022;12(2):e2022104.
Reich, K., Kristensen, L. E., Smith, S. D., Rich, P., Sapin, C., Leage, S. L., McKenzie, R., Schuster, C., Riedl, E., & Gooderham, M. (2022). Efficacy and Safety of Ixekizumab Versus Adalimumab in Biologic-naïve Patients With Active Psoriatic Arthritis and Moderate-to-severe Psoriasis: 52-week Results From the Randomized SPIRIT-H2H Trial. Dermatology Practical & Conceptual, 12(2), e2022104. https://doi.org/10.5826/dpc.1202a104
Reich K, et al. Efficacy and Safety of Ixekizumab Versus Adalimumab in Biologic-naïve Patients With Active Psoriatic Arthritis and Moderate-to-severe Psoriasis: 52-week Results From the Randomized SPIRIT-H2H Trial. Dermatol Pract Concept. 2022;12(2):e2022104. PubMed PMID: 35646453.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of Ixekizumab Versus Adalimumab in Biologic-naïve Patients With Active Psoriatic Arthritis and Moderate-to-severe Psoriasis: 52-week Results From the Randomized SPIRIT-H2H Trial. AU - Reich,Kristian, AU - Kristensen,Lars Erik, AU - Smith,Saxon D, AU - Rich,Phoebe, AU - Sapin,Christophe, AU - Leage,Soyi Liu, AU - McKenzie,Robert, AU - Schuster,Christopher, AU - Riedl,Elisabeth, AU - Gooderham,Melinda, Y1 - 2022/04/01/ PY - 2021/10/25/accepted PY - 2022/6/1/entrez PY - 2022/6/2/pubmed PY - 2022/6/2/medline KW - KW - SPIRIT-H2H KW - adalimumab KW - ixekizumab KW - nail psoriasis KW - psoriasis SP - e2022104 EP - e2022104 JF - Dermatology practical & conceptual JO - Dermatol Pract Concept VL - 12 IS - 2 N2 - Introduction: The randomized, open-label, assessor-blinded, parallel-group SPIRIT-H2H trial (NCT03151551) demonstrated superiority of ixekizumab over adalimumab in simultaneously achieving improvement in joint symptoms (American College of Rheumatology [ACR]50) and skin clearance (Psoriasis Area and Severity Index [PASI]100) in biologic-naïve patients with active psoriatic arthritis (PsA) and plaque psoriasis (PsO) at Week (W) 24. Higher efficacy of ixekizumab versus adalimumab was maintained through W52. Objectives: This analysis investigated efficacy and safety of ixekizumab and adalimumab in the subgroup of patients with PsA and moderate-to-severe PsO through W52. Methods: Efficacy and safety outcomes were analyzed in patients with PsA and moderate-to-severe PsO (PASI ≥ 12, Body Surface Area ≥ 10%, static Physician Global Assessment ≥ 3) through W52. Categorical and continuous outcomes were analyzed using logistic regression models and mixed model for repeated measures, respectively. Results: More ixekizumab-versus adalimumab-treated patients simultaneously achieved PASI100 and ACR50 at W24 (40.8% versus 17.6%, P = 0.015) and W52 (38.8% versus 17.6%, P = 0.026). Likewise, more ixekizumab-versus adalimumab-treated patients achieved PASI100 (59.2% versus 25.5%, P = 0.001) and PASI90 (81.6% versus 60.8%, P = 0.028) through W52, and nail PsO clearance at W24. Joint symptom improvements were comparable between groups. No new safety findings were reported. Conclusions: Ixekizumab had higher efficacy than adalimumab in simultaneous achievement of ACR50 and PASI100 at W24 and W52 in patients with PsA and moderate-to-severe PsO. Ixekizumab-treated patients showed higher response rates for nail PsO clearance and for reporting minimal or no impact on quality of life at W24. SN - 2160-9381 UR - https://www.unboundmedicine.com/medline/citation/35646453/Efficacy_and_Safety_of_Ixekizumab_Versus_Adalimumab_in_Biologic_naïve_Patients_With_Active_Psoriatic_Arthritis_and_Moderate_to_severe_Psoriasis:_52_week_Results_From_the_Randomized_SPIRIT_H2H_Trial_ DB - PRIME DP - Unbound Medicine ER -
Grapherence [↓5 ↑38]

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