Efficacy of Apremilast in Patients with Psoriasis with Limited Skin Involvement, Including High-Impact Site Involvement: A Pooled Analysis of Six Trials
10 affiliations
- 1Yale School of Medicine, New Haven, CT USA
- 2Central Connecticut Dermatology, 1 Willowbrook Rd, Suite 2, Cromwell, CT 06416 USA
- 3Icahn School of Medicine at Mount Sinai, New York, NY USA
- 4Department of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands
- 5Henry Ford Health System, West Bloomfield, MI USA
- 6Department of Dermatology and Department of Medicine, Division of Rheumatology, UT Southwestern Medical Center, Dallas, TX USA
- 7Tokyo Medical University, Chome-7-1, Nishi-Shinjuku, Shinjuku, Tokyo Japan
- 8University Hospital of Verona, Verona, Italy
- 9Amgen Inc., Thousand Oaks, CA USA
- 10Psoriasis Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany
Abstract
Introduction: Plaque psoriasis is associated with decreased quality of life (QOL) even in patients with limited skin involvement, particularly those with high-impact site (HIS) involvement. The efficacy of apremilast in patients with plaque psoriasis has been demonstrated in phase 3 and 4 clinical trials. Here, we evaluated the efficacy of apremilast across six clinical trials for patients with psoriasis with low affected body surface area (BSA), including patients with HIS involvement.
Methods: Data were pooled across five randomized, double-blind, placebo-controlled trials (patients were randomized to apremilast or placebo until week 16, followed by open-label apremilast) and one single-arm, open-label trial of apremilast for the treatment of plaque psoriasis. Patients in this post hoc pooled analysis had limited skin involvement (BSA, 3–10%), many with HIS involvement in the scalp, genital area, and/or nails. Week 16 and 32 assessments included BSA, Psoriasis Area and Severity Index (PASI), static Physician’s Global Assessment, Dermatology Life Quality Index, and HIS-specific measurements. Nonresponder imputation was used for missing data for binary endpoints; a mixed-effects model for repeated measures was used to analyze continuous endpoints.
Results: Of 1152 patients in this analysis (mean BSA, 6.3%; PASI, 6.8), those who received apremilast (n = 671) versus placebo (n = 481) had significantly greater improvements in skin clearance and QOL at week 16 (all endpoints assessed, p < 0.0001), with improvements generally maintained at week 32. Apremilast also yielded clinically greater improvements in patients with scalp, genital, and/or nail psoriasis at week 16 versus placebo (all endpoints assessed in affected patients, p < 0.01), with responses generally maintained at week 32.
Conclusion: Apremilast improved skin clearance and QOL at week 16, and responses were generally maintained at week 32, in a pooled population of patients with psoriasis with limited skin involvement, including HIS involvement.
Graphical abstract available for this article.
Trial Registration ClinicalTrials.gov identifiers—NCT03721172, NCT03777436, NCT03123471, NCT03774875, NCT02425826, and NCT03930186.
Graphical Abstract:
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s13555-026-01921-9.
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BibTeX
@article{strober2026efficacy,
title = {{Efficacy of Apremilast in Patients with Psoriasis with Limited Skin Involvement, Including High-Impact Site Involvement: A Pooled Analysis of Six Trials}},
author = {Bruce Strober and Mark Lebwohl and Peter van de Kerkhof and Linda Stein Gold and Joseph F. Merola and Yukari Okubo and Paolo Gisondi and Zhenwei Zhou and Siddharth Chaudhari and Cynthia Deignan and Ulrich Mrowietz},
journal = {Dermatology and Therapy},
year = {2026},
month = oct,
doi = {10.1007/s13555-026-01921-9},
url = {https://doi.org/10.1007/s13555-026-01921-9},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Efficacy of Apremilast in Patients with Psoriasis with Limited Skin Involvement, Including High-Impact Site Involvement: A Pooled Analysis of Six Trials
AU - Bruce Strober
AU - Mark Lebwohl
AU - Peter van de Kerkhof
AU - Linda Stein Gold
AU - Joseph F. Merola
AU - Yukari Okubo
AU - Paolo Gisondi
AU - Zhenwei Zhou
AU - Siddharth Chaudhari
AU - Cynthia Deignan
AU - Ulrich Mrowietz
PY - 2026
DA - 2026/10/02
JO - Dermatology and Therapy
DO - 10.1007/s13555-026-01921-9
UR - https://doi.org/10.1007/s13555-026-01921-9
AB - Introduction: Plaque psoriasis is associated with decreased quality of life (QOL) even in patients with limited skin involvement, particularly those with high-impact site (HIS) involvement. The efficacy of apremilast in patients with plaque psoriasis has been demonstrated in phase 3 and 4 clinical trials. Here, we evaluated the efficacy of apremilast across six clinical trials for patients with psoriasis with low affected body surface area (BSA), including patients with HIS involvement. Methods: Data were pooled across five randomized, double-blind, placebo-controlled trials (patients were randomized to apremilast or placebo until week 16, followed by open-label apremilast) and one single-arm, open-label trial of apremilast for the treatment of plaque psoriasis. Patients in this post hoc pooled analysis had limited skin involvement (BSA, 3–10%), many with HIS involvement in the scalp, genital area, and/or nails. Week 16 and 32 assessments included BSA, Psoriasis Area and Severity Index (PASI), static Physician’s Global Assessment, Dermatology Life Quality Index, and HIS-specific measurements. Nonresponder imputation was used for missing data for binary endpoints; a mixed-effects model for repeated measures was used to analyze continuous endpoints. Results: Of 1152 patients in this analysis (mean BSA, 6.3%; PASI, 6.8), those who received apremilast (n = 671) versus placebo (n = 481) had significantly greater improvements in skin clearance and QOL at week 16 (all endpoints assessed, p < 0.0001), with improvements generally maintained at week 32. Apremilast also yielded clinically greater improvements in patients with scalp, genital, and/or nail psoriasis at week 16 versus placebo (all endpoints assessed in affected patients, p < 0.01), with responses generally maintained at week 32. Conclusion: Apremilast improved skin clearance and QOL at week 16, and responses were generally maintained at week 32, in a pooled population of patients with psoriasis with limited skin involvement, including HIS involvement. Graphical abstract available for this article. Trial Registration ClinicalTrials.gov identifiers—NCT03721172, NCT03777436, NCT03123471, NCT03774875, NCT02425826, and NCT03930186. Graphical Abstract: Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s13555-026-01921-9.
SN - 2193-8210
SN - 2190-9172
ER -