Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study
Abstract Introduction Risankizumab has demonstrated superior efficacy compared to other psoriasis treatments, including secukinumab, adalimumab, and ustekinumab; switching to risankizumab from other psoriasis treatments has shown superior clinical and quality of life (QoL) outcomes. We evaluated the...
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Adis, Springer Healthcare
2024-11-01
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| Series: | Dermatology and Therapy |
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| Online Access: | https://doi.org/10.1007/s13555-024-01292-z |
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| author | Richard B. Warren Lev Pavlovsky Antonio Costanzo Michael Bukhalo Neil J. Korman Yu-Huei Huang Georgios Kokolakis Andreas Pinter Nadia Ibrahim Yanbing Zheng Leonidas Drogaris Vassilis Stakias Ahmed M. Soliman Simone Rubant Diamant Thaçi |
| author_facet | Richard B. Warren Lev Pavlovsky Antonio Costanzo Michael Bukhalo Neil J. Korman Yu-Huei Huang Georgios Kokolakis Andreas Pinter Nadia Ibrahim Yanbing Zheng Leonidas Drogaris Vassilis Stakias Ahmed M. Soliman Simone Rubant Diamant Thaçi |
| author_sort | Richard B. Warren |
| collection | DOAJ |
| description | Abstract Introduction Risankizumab has demonstrated superior efficacy compared to other psoriasis treatments, including secukinumab, adalimumab, and ustekinumab; switching to risankizumab from other psoriasis treatments has shown superior clinical and quality of life (QoL) outcomes. We evaluated the efficacy and safety of directly switching patients with moderate-to-severe plaque psoriasis and a suboptimal response to interleukin (IL)-17 inhibitors (secukinumab or ixekizumab) to risankizumab. Methods This 52-week, phase 3b study enrolled patients (≥ 18 years) with moderate-to-severe plaque psoriasis who had previously been treated with the recommended dose of secukinumab or ixekizumab for ≥ 6 months but did not achieve an optimal response (static Physician's Global Assessment [sPGA] 2/3; body surface are [BSA] 3– < 10%). Patients received subcutaneous risankizumab (150 mg) without washout. The primary endpoint was the proportion of patients achieving sPGA of 0/1 at week 16. Secondary endpoints included sPGA 0/1 at week 52, sPGA 0, Dermatology Life Quality Index (DLQI) 0/1, and Psoriasis Symptoms Scale (PSS) 0 at weeks 16 and 52. Safety was monitored throughout the study. Results The study included 244 patients. sPGA 0/1 was achieved by 57.4% and 62.3% at week 16 and 52. At week 16, sPGA 0, DLQI 0/1, and PSS 0 were achieved by 20.5%, 40.2%, and 20.9%, respectively. At week 52, these proportions increased to 27.1% for sPGA 0, 47.2% for DLQI 0/1, and 27.5% for PSS 0. Most frequently reported adverse events (reported in ≥ 5% of patients) in risankizumab-treated patients were COVID-19 infection (8.6%) and nasopharyngitis (5.7%). No new safety signals were observed. Conclusions Directly switching to risankizumab improved outcomes and QoL in patients with moderate-to-severe psoriasis who had suboptimal responses to anti-IL-17 inhibitors (secukinumab or ixekizumab). The safety results are consistent with previously reported safety of risankizumab. This study supports the efficacy of risankizumab in patients previously treated with biologics, including IL-17 inhibitors, and suggests a direct switch to risankizumab for improved clinical outcomes and QoL. Clinical Trials ClinicalTrials.gov identifier: NCT04102007. Graphical Abstract |
| format | Article |
| id | doaj-art-34355c7facb14d3c80d5e8afaa8abaab |
| institution | Kabale University |
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| language | English |
| publishDate | 2024-11-01 |
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| series | Dermatology and Therapy |
| spelling | doaj-art-34355c7facb14d3c80d5e8afaa8abaab2025-01-19T12:11:04ZengAdis, Springer HealthcareDermatology and Therapy2193-82102190-91722024-11-0114123273329010.1007/s13555-024-01292-zEfficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) StudyRichard B. Warren0Lev Pavlovsky1Antonio Costanzo2Michael Bukhalo3Neil J. Korman4Yu-Huei Huang5Georgios Kokolakis6Andreas Pinter7Nadia Ibrahim8Yanbing Zheng9Leonidas Drogaris10Vassilis Stakias11Ahmed M. Soliman12Simone Rubant13Diamant Thaçi14The Dermatology Centre, Northern Care Alliance NHS Foundation Trust, Salford Royal NHS Foundation TrustSackler Faculty of Medicine, Tel Aviv UniversityDepartment of Biomedical Sciences, Humanitas UniversityArlington DermatologyDepartment of Dermatology, University Hospitals Cleveland Medical Center and Case Western Reserve UniversityDepartment of Dermatology, Linkou Branch, Chang Gung Memorial HospitalPsoriasis Research and Treatment Center, Department of Dermatology, Venereology and Allergology, Charité-Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin and Humboldt-Universität zu BerlinDepartment of Dermatology, University Hospital Frankfurt am MainAbbVie Inc.AbbVie Inc.AbbVie Inc.AbbVie Inc.AbbVie Inc.AbbVie DeutschlandInstitute and Comprehensive Center Inflammation Medicine, University of LübeckAbstract Introduction Risankizumab has demonstrated superior efficacy compared to other psoriasis treatments, including secukinumab, adalimumab, and ustekinumab; switching to risankizumab from other psoriasis treatments has shown superior clinical and quality of life (QoL) outcomes. We evaluated the efficacy and safety of directly switching patients with moderate-to-severe plaque psoriasis and a suboptimal response to interleukin (IL)-17 inhibitors (secukinumab or ixekizumab) to risankizumab. Methods This 52-week, phase 3b study enrolled patients (≥ 18 years) with moderate-to-severe plaque psoriasis who had previously been treated with the recommended dose of secukinumab or ixekizumab for ≥ 6 months but did not achieve an optimal response (static Physician's Global Assessment [sPGA] 2/3; body surface are [BSA] 3– < 10%). Patients received subcutaneous risankizumab (150 mg) without washout. The primary endpoint was the proportion of patients achieving sPGA of 0/1 at week 16. Secondary endpoints included sPGA 0/1 at week 52, sPGA 0, Dermatology Life Quality Index (DLQI) 0/1, and Psoriasis Symptoms Scale (PSS) 0 at weeks 16 and 52. Safety was monitored throughout the study. Results The study included 244 patients. sPGA 0/1 was achieved by 57.4% and 62.3% at week 16 and 52. At week 16, sPGA 0, DLQI 0/1, and PSS 0 were achieved by 20.5%, 40.2%, and 20.9%, respectively. At week 52, these proportions increased to 27.1% for sPGA 0, 47.2% for DLQI 0/1, and 27.5% for PSS 0. Most frequently reported adverse events (reported in ≥ 5% of patients) in risankizumab-treated patients were COVID-19 infection (8.6%) and nasopharyngitis (5.7%). No new safety signals were observed. Conclusions Directly switching to risankizumab improved outcomes and QoL in patients with moderate-to-severe psoriasis who had suboptimal responses to anti-IL-17 inhibitors (secukinumab or ixekizumab). The safety results are consistent with previously reported safety of risankizumab. This study supports the efficacy of risankizumab in patients previously treated with biologics, including IL-17 inhibitors, and suggests a direct switch to risankizumab for improved clinical outcomes and QoL. Clinical Trials ClinicalTrials.gov identifier: NCT04102007. Graphical Abstracthttps://doi.org/10.1007/s13555-024-01292-zPsoriasisEfficacySafetyRisankizumab |
| spellingShingle | Richard B. Warren Lev Pavlovsky Antonio Costanzo Michael Bukhalo Neil J. Korman Yu-Huei Huang Georgios Kokolakis Andreas Pinter Nadia Ibrahim Yanbing Zheng Leonidas Drogaris Vassilis Stakias Ahmed M. Soliman Simone Rubant Diamant Thaçi Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study Dermatology and Therapy Psoriasis Efficacy Safety Risankizumab |
| title | Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study |
| title_full | Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study |
| title_fullStr | Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study |
| title_full_unstemmed | Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study |
| title_short | Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study |
| title_sort | efficacy and safety of risankizumab in patients with psoriasis showing suboptimal response to secukinumab or ixekizumab results from a phase 3b open label single arm aimm study |
| topic | Psoriasis Efficacy Safety Risankizumab |
| url | https://doi.org/10.1007/s13555-024-01292-z |
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