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Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis.
Dermatol Ther (Heidelb). 2022 Apr; 12(4):911-920.DT

Abstract

INTRODUCTION

The lifetime incidence of nail psoriasis in patients with psoriasis is 80-90%, with 23-27% of patients having nail psoriasis at any given time. Nail psoriasis is even more prevalent in patients with comorbid psoriatic arthritis. Complete psoriasis clearance, an achievable therapeutic goal, should ideally include the resolution of nail psoriasis. Here, we assessed simultaneous skin and nail clearance in patients with psoriasis across five head-to-head trials comparing ixekizumab with other biologics.

METHODS

Data were assessed in patients with moderate-to-severe psoriasis (with or without psoriatic arthritis) with nail psoriasis at baseline from the IXORA-R, IXORA-S, UNCOVER-2, UNCOVER-3, and SPIRIT-H2H trials. Ixekizumab patients received IXEQ2W to week 12 and IXEQ4W beyond week 12. PASI 100 depicted complete skin clearance, and PGA-F 0 (IXORA-R) or NAPSI 0 (all other trials) depicted complete nail clearance. Treatment comparisons were evaluated using the Cochran-Mantel-Haenszel test. Non-responder imputation was used for missing data.

RESULTS

Ixekizumab achieved significantly greater simultaneous skin and nail complete clearance than etanercept (UNCOVER-2: p < 0.001 and UNCOVER-3: p < 0.001) at week 12, demonstrating an efficacious and rapid response. Across all five head-to-head trials, ixekizumab achieved a high rate of simultaneous skin and nail clearance (range: 28.6-45.9% of patients) by week 24 that was maintained up to week 52 (range: 40.5-51.4% of patients). Ixekizumab achieved numerically greater simultaneous complete clearance than guselkumab at week 24 (p = 0.079), but statistically significant greater simultaneous clearance compared to ustekinumab (p < 0.001) and adalimumab (p = 0.006) at week 24 and week 52 (p < 0.001 and p = 0.007, respectively).

CONCLUSION

In five head-to-head trials, ixekizumab-treated patients had higher rates of simultaneous complete skin and nail clearance compared to etanercept, guselkumab, ustekinumab, and adalimumab, thereby reinforcing ixekizumab's ability to achieve high levels of efficacy in multiple domains of psoriatic disease.

TRIAL REGISTRATION

NCT01474512, NCT01597245, NCT01646177, NCT03573323, NCT02561806, and NCT03151551.

Authors+Show Affiliations

University of Alabama, Birmingham, AL, USA. beelewski@gmail.com.Oregon Medical Research Center, Portland, OR, USA.Eli Lilly and Company, Indianapolis, IN, USA.Eli Lilly and Company, Indianapolis, IN, USA.Syneos Health, Raleigh, NC, USA.Eli Lilly and Company, Indianapolis, IN, USA. University of Cincinnati, Cincinnati, OH, USA.Department of Medicine, Division of Rheumatology, and Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.Department of Dermatology, Icahn School of Medicine, New York, NY, USA.Guenther Research Inc., London, ON, Canada. Western University, London, ON, Canada.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

35279805

Citation

Elewski, Boni E., et al. "Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis." Dermatology and Therapy, vol. 12, no. 4, 2022, pp. 911-920.
Elewski BE, Blauvelt A, Gallo G, et al. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022;12(4):911-920.
Elewski, B. E., Blauvelt, A., Gallo, G., Wolf, E., McKean-Matthews, M., Burge, R., Merola, J. F., Gottlieb, A. B., & Guenther, L. C. (2022). Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatology and Therapy, 12(4), 911-920. https://doi.org/10.1007/s13555-022-00704-2
Elewski BE, et al. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022;12(4):911-920. PubMed PMID: 35279805.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. AU - Elewski,Boni E, AU - Blauvelt,Andrew, AU - Gallo,Gaia, AU - Wolf,Eric, AU - McKean-Matthews,Missy, AU - Burge,Russel, AU - Merola,Joseph F, AU - Gottlieb,Alice B, AU - Guenther,Lyn C, Y1 - 2022/03/13/ PY - 2022/01/06/received PY - 2022/02/22/accepted PY - 2022/3/14/pubmed PY - 2022/3/14/medline PY - 2022/3/13/entrez KW - Adalimumab KW - Etanercept KW - Guselkumab KW - IL 17A inhibitor KW - Ixekizumab KW - Moderate-to-severe psoriasis KW - Psoriatic arthritis KW - Ustekinumab SP - 911 EP - 920 JF - Dermatology and therapy JO - Dermatol Ther (Heidelb) VL - 12 IS - 4 N2 - INTRODUCTION: The lifetime incidence of nail psoriasis in patients with psoriasis is 80-90%, with 23-27% of patients having nail psoriasis at any given time. Nail psoriasis is even more prevalent in patients with comorbid psoriatic arthritis. Complete psoriasis clearance, an achievable therapeutic goal, should ideally include the resolution of nail psoriasis. Here, we assessed simultaneous skin and nail clearance in patients with psoriasis across five head-to-head trials comparing ixekizumab with other biologics. METHODS: Data were assessed in patients with moderate-to-severe psoriasis (with or without psoriatic arthritis) with nail psoriasis at baseline from the IXORA-R, IXORA-S, UNCOVER-2, UNCOVER-3, and SPIRIT-H2H trials. Ixekizumab patients received IXEQ2W to week 12 and IXEQ4W beyond week 12. PASI 100 depicted complete skin clearance, and PGA-F 0 (IXORA-R) or NAPSI 0 (all other trials) depicted complete nail clearance. Treatment comparisons were evaluated using the Cochran-Mantel-Haenszel test. Non-responder imputation was used for missing data. RESULTS: Ixekizumab achieved significantly greater simultaneous skin and nail complete clearance than etanercept (UNCOVER-2: p < 0.001 and UNCOVER-3: p < 0.001) at week 12, demonstrating an efficacious and rapid response. Across all five head-to-head trials, ixekizumab achieved a high rate of simultaneous skin and nail clearance (range: 28.6-45.9% of patients) by week 24 that was maintained up to week 52 (range: 40.5-51.4% of patients). Ixekizumab achieved numerically greater simultaneous complete clearance than guselkumab at week 24 (p = 0.079), but statistically significant greater simultaneous clearance compared to ustekinumab (p < 0.001) and adalimumab (p = 0.006) at week 24 and week 52 (p < 0.001 and p = 0.007, respectively). CONCLUSION: In five head-to-head trials, ixekizumab-treated patients had higher rates of simultaneous complete skin and nail clearance compared to etanercept, guselkumab, ustekinumab, and adalimumab, thereby reinforcing ixekizumab's ability to achieve high levels of efficacy in multiple domains of psoriatic disease. TRIAL REGISTRATION: NCT01474512, NCT01597245, NCT01646177, NCT03573323, NCT02561806, and NCT03151551. SN - 2193-8210 UR - https://www.unboundmedicine.com/medline/citation/35279805/Simultaneous_Nail_and_Skin_Clearance_in_Ixekizumab_Head_to_Head_Trials_for_Moderate_to_Severe_Psoriasis_and_Psoriatic_Arthritis_ DB - PRIME DP - Unbound Medicine ER -