Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials
Abstract Introduction Psoriasis in high-impact areas, including the scalp, nails, palms, and soles, can disproportionately impair patient quality of life. Here, we evaluate the 2-year efficacy of bimekizumab treatment in patients with moderate to severe plaque psoriasis in post hoc analyses of five...
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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/s13555-024-01295-w |
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| author | Joseph F. Merola Alice B. Gottlieb Andreas Pinter Boni Elewski Melinda Gooderham Richard B. Warren Stefano Piaserico Krista Wixted Nancy Cross Nicola Tilt Susanne Wiegratz Ulrich Mrowietz |
| author_facet | Joseph F. Merola Alice B. Gottlieb Andreas Pinter Boni Elewski Melinda Gooderham Richard B. Warren Stefano Piaserico Krista Wixted Nancy Cross Nicola Tilt Susanne Wiegratz Ulrich Mrowietz |
| author_sort | Joseph F. Merola |
| collection | DOAJ |
| description | Abstract Introduction Psoriasis in high-impact areas, including the scalp, nails, palms, and soles, can disproportionately impair patient quality of life. Here, we evaluate the 2-year efficacy of bimekizumab treatment in patients with moderate to severe plaque psoriasis in post hoc analyses of five phase 3/3b trials. Methods High-impact area efficacy data were pooled through 2 years across five phase 3/3b trials: BE VIVID, BE READY, BE SURE, their ongoing open-label extension (OLE) BE BRIGHT, and BE RADIANT (including its double-blinded treatment period and the first year of its OLE). Complete clearance of psoriasis in high-impact areas is reported over 2 years using the scalp Investigator’s Global Assessment (IGA), palmoplantar IGA, and modified Nail Psoriasis Severity Index (mNAPSI). Patients included in these analyses had baseline moderate to severe scalp or palmoplantar involvement (scalp or palmoplantar IGA score ≥ 3) or mNAPSI score > 10. Results A total of 1107 patients were randomized to bimekizumab and entered the OLEs. Subsets of 821 patients had scalp IGA ≥ 3 at baseline, 377 had mNAPSI > 10, and 193 had palmoplantar IGA ≥ 3. Complete scalp clearance in patients with baseline scalp IGA ≥ 3 randomized to bimekizumab was achieved rapidly, with high responses sustained from first (86.4%) to second year (85.9%). Nail clearance responses in patients with baseline mNAPSI > 10 increased from 63.4% to 68.5% from first to second year. Palmoplantar clearance in patients with baseline palmoplantar IGA ≥ 3 was sustained from first (88.3%) to second year (89.8%). Similar trends were seen in the 374 patients who received bimekizumab 320 mg every 4 weeks (Q4W)/every 8 weeks (Q8W) initial/maintenance dosing. Conclusion In these analyses pooled across 2 years, bimekizumab showed sustained efficacy in psoriasis in high-impact areas. Clinicaltrials.gov Trial Registration Numbers NCT03370133, NCT03410992, NCT03412747, NCT03598790, NCT03536884. |
| format | Article |
| id | doaj-art-baf9bbc677c049fd857d3a8c7639ead5 |
| institution | Kabale University |
| issn | 2193-8210 2190-9172 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Adis, Springer Healthcare |
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| series | Dermatology and Therapy |
| spelling | doaj-art-baf9bbc677c049fd857d3a8c7639ead52024-12-01T12:10:43ZengAdis, Springer HealthcareDermatology and Therapy2193-82102190-91722024-11-0114123291330610.1007/s13555-024-01295-wBimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled TrialsJoseph F. Merola0Alice B. Gottlieb1Andreas Pinter2Boni Elewski3Melinda Gooderham4Richard B. Warren5Stefano Piaserico6Krista Wixted7Nancy Cross8Nicola Tilt9Susanne Wiegratz10Ulrich Mrowietz11Department of Dermatology and Department of Medicine, Division of Rheumatology, UT Southwestern Medical CenterDepartment of Dermatology, The Icahn School of Medicine at Mount SinaiUniversity Hospital FrankfurtDepartment of Dermatology, University Hospitals of Cleveland, Case Western Reserve UniversitySKiN Centre for Dermatology, Probity Medical ResearchDermatology Centre, Northern Care Alliance NHS Foundation TrustDermatology Unit, Department of Medicine, Università Di PadovaUCBUCBUCBUCBPsoriasis-Center, Department of Dermatology, University Medical Center Schleswig-HolsteinAbstract Introduction Psoriasis in high-impact areas, including the scalp, nails, palms, and soles, can disproportionately impair patient quality of life. Here, we evaluate the 2-year efficacy of bimekizumab treatment in patients with moderate to severe plaque psoriasis in post hoc analyses of five phase 3/3b trials. Methods High-impact area efficacy data were pooled through 2 years across five phase 3/3b trials: BE VIVID, BE READY, BE SURE, their ongoing open-label extension (OLE) BE BRIGHT, and BE RADIANT (including its double-blinded treatment period and the first year of its OLE). Complete clearance of psoriasis in high-impact areas is reported over 2 years using the scalp Investigator’s Global Assessment (IGA), palmoplantar IGA, and modified Nail Psoriasis Severity Index (mNAPSI). Patients included in these analyses had baseline moderate to severe scalp or palmoplantar involvement (scalp or palmoplantar IGA score ≥ 3) or mNAPSI score > 10. Results A total of 1107 patients were randomized to bimekizumab and entered the OLEs. Subsets of 821 patients had scalp IGA ≥ 3 at baseline, 377 had mNAPSI > 10, and 193 had palmoplantar IGA ≥ 3. Complete scalp clearance in patients with baseline scalp IGA ≥ 3 randomized to bimekizumab was achieved rapidly, with high responses sustained from first (86.4%) to second year (85.9%). Nail clearance responses in patients with baseline mNAPSI > 10 increased from 63.4% to 68.5% from first to second year. Palmoplantar clearance in patients with baseline palmoplantar IGA ≥ 3 was sustained from first (88.3%) to second year (89.8%). Similar trends were seen in the 374 patients who received bimekizumab 320 mg every 4 weeks (Q4W)/every 8 weeks (Q8W) initial/maintenance dosing. Conclusion In these analyses pooled across 2 years, bimekizumab showed sustained efficacy in psoriasis in high-impact areas. Clinicaltrials.gov Trial Registration Numbers NCT03370133, NCT03410992, NCT03412747, NCT03598790, NCT03536884.https://doi.org/10.1007/s13555-024-01295-wBimekizumabClinical trialEfficacyHigh-impact areasNailPalmoplantar |
| spellingShingle | Joseph F. Merola Alice B. Gottlieb Andreas Pinter Boni Elewski Melinda Gooderham Richard B. Warren Stefano Piaserico Krista Wixted Nancy Cross Nicola Tilt Susanne Wiegratz Ulrich Mrowietz Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials Dermatology and Therapy Bimekizumab Clinical trial Efficacy High-impact areas Nail Palmoplantar |
| title | Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials |
| title_full | Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials |
| title_fullStr | Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials |
| title_full_unstemmed | Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials |
| title_short | Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials |
| title_sort | bimekizumab efficacy in high impact areas pooled 2 year analysis in scalp nail and palmoplantar psoriasis from phase 3 3b randomized controlled trials |
| topic | Bimekizumab Clinical trial Efficacy High-impact areas Nail Palmoplantar |
| url | https://doi.org/10.1007/s13555-024-01295-w |
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