Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis
Background: Psoriasis is a chronic inflammatory skin disease requiring prolonged treatment. New biologic therapies require long-term evaluation to assess the durability of their efficacy and safety profiles over time. Objectives: To evaluate the long-term efficacy and safety of risankizumab (RZB) fo...
| Authors: | ; ; ; ; ; ; ; ; ; ; ; |
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| Format: | Article |
| Publication date: | 2021 |
| Country: | España |
| Institution: | Universitat Autònoma de Barcelona |
| Repository: | Dipòsit Digital de Documents de la UAB |
| Language: | English |
| OAI Identifier: | oai:ddd.uab.cat:270201 |
| Online Access: | https://ddd.uab.cat/record/270201 https://dx.doi.org/urn:doi:10.1111/bjd.20595 |
| Access Level: | Open access |
| Keyword: | Adult Antibodies, Monoclonal Double-Blind Method Follow-Up Studies Humans Psoriasis Quality of Life Severity of Illness Index Treatment Outcome |
| _version_ | 1878733025302282240 |
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| author | Papp, Kim A.|||0000-0001-9557-3642 |
| author2 | Lebwohl, Mark Gabriel Puig Sanz, Lluís|||0000-0001-6083-0952 Ohtsuki, Mamitaro Beissert, Stefan Zeng, Jiewei Rubant, Simone A. Sinvhal, Ranjeeta Zhao, Yan Soliman, Ahmed M.|||0009-0008-8632-1396 Alperovich, Gabriela Leonardi, Craig L. |
| author2_role | author author author author author author author author author author author |
| author_browse | Alperovich, Gabriela Beissert, Stefan Lebwohl, Mark Gabriel Leonardi, Craig L. Ohtsuki, Mamitaro Papp, Kim A.|||0000-0001-9557-3642 Puig Sanz, Lluís|||0000-0001-6083-0952 Rubant, Simone A. Sinvhal, Ranjeeta Soliman, Ahmed M.|||0009-0008-8632-1396 Zeng, Jiewei Zhao, Yan |
| author_facet | Papp, Kim A.|||0000-0001-9557-3642 Lebwohl, Mark Gabriel Puig Sanz, Lluís|||0000-0001-6083-0952 Ohtsuki, Mamitaro Beissert, Stefan Zeng, Jiewei Rubant, Simone A. Sinvhal, Ranjeeta Zhao, Yan Soliman, Ahmed M.|||0009-0008-8632-1396 Alperovich, Gabriela Leonardi, Craig L. |
| author_role | author |
| collection | Dipòsit Digital de Documents de la UAB |
| description | Background: Psoriasis is a chronic inflammatory skin disease requiring prolonged treatment. New biologic therapies require long-term evaluation to assess the durability of their efficacy and safety profiles over time. Objectives: To evaluate the long-term efficacy and safety of risankizumab (RZB) for the treatment of psoriasis. Methods: LIMMitless is an ongoing, phase III, open-label extension study evaluating the long-term efficacy and safety of RZB in adults with moderate-to-severe plaque psoriasis following multiple phase II/III studies. This analysis assessed efficacy through 172 weeks of continuous RZB treatment by examining the proportion of patients achieving ≥ 90% or 100% improvement in Psoriasis Area and Severity Index (PASI 90 and PASI 100), static Physician's Global Assessment of clear or almost clear (sPGA 0/1) and Dermatology Life Quality Index of no effect on quality of life (DLQI 0/1). Safety was assessed by recording adverse events (AEs) through the data cutoff date. The study is registered at ClinicalTrials.gov (identifier: NCT03047395). Results: Of 955 patients randomized to RZB 150 mg in the base studies, 897 patients continued into LIMMitless; 799 patients were still receiving treatment in LIMMitless at the time of data cutoff for this analysis. After 172 weeks of continuous RZB treatment, 85·5% of patients achieved PASI 90, 54·4% achieved PASI 100, 85·2% achieved sPGA 0/1, and 78·4% achieved DLQI 0/1 using modified nonresponder imputation. Rates of AEs leading to discontinuation and AEs of safety interest were low with long-term treatment and comparable with those identified in the base studies. Conclusions: Overall, long-term continuous RZB was well tolerated and showed high and durable efficacy over 172 weeks. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_4e913fcf4e4bd4b7b7dcfa1bbf371892 |
| institution | Universitat Autònoma de Barcelona |
| instname_str | Universitat Autònoma de Barcelona |
| language | eng |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:ddd.uab.cat:270201 |
| publishDate | 2021 |
| publishDateSort | 2021 |
| reponame_str | Dipòsit Digital de Documents de la UAB |
| spelling | Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up Papp, Kim A.|||0000-0001-9557-3642 Lebwohl, Mark Gabriel Puig Sanz, Lluís|||0000-0001-6083-0952 Ohtsuki, Mamitaro Beissert, Stefan Zeng, Jiewei Rubant, Simone A. Sinvhal, Ranjeeta Zhao, Yan Soliman, Ahmed M.|||0009-0008-8632-1396 Alperovich, Gabriela Leonardi, Craig L. Adult Antibodies, Monoclonal Double-Blind Method Follow-Up Studies Humans Psoriasis Quality of Life Severity of Illness Index Treatment Outcome Background: Psoriasis is a chronic inflammatory skin disease requiring prolonged treatment. New biologic therapies require long-term evaluation to assess the durability of their efficacy and safety profiles over time. Objectives: To evaluate the long-term efficacy and safety of risankizumab (RZB) for the treatment of psoriasis. Methods: LIMMitless is an ongoing, phase III, open-label extension study evaluating the long-term efficacy and safety of RZB in adults with moderate-to-severe plaque psoriasis following multiple phase II/III studies. This analysis assessed efficacy through 172 weeks of continuous RZB treatment by examining the proportion of patients achieving ≥ 90% or 100% improvement in Psoriasis Area and Severity Index (PASI 90 and PASI 100), static Physician's Global Assessment of clear or almost clear (sPGA 0/1) and Dermatology Life Quality Index of no effect on quality of life (DLQI 0/1). Safety was assessed by recording adverse events (AEs) through the data cutoff date. The study is registered at ClinicalTrials.gov (identifier: NCT03047395). Results: Of 955 patients randomized to RZB 150 mg in the base studies, 897 patients continued into LIMMitless; 799 patients were still receiving treatment in LIMMitless at the time of data cutoff for this analysis. After 172 weeks of continuous RZB treatment, 85·5% of patients achieved PASI 90, 54·4% achieved PASI 100, 85·2% achieved sPGA 0/1, and 78·4% achieved DLQI 0/1 using modified nonresponder imputation. Rates of AEs leading to discontinuation and AEs of safety interest were low with long-term treatment and comparable with those identified in the base studies. Conclusions: Overall, long-term continuous RZB was well tolerated and showed high and durable efficacy over 172 weeks. https://ddd.uab.cat/record/270201 https://dx.doi.org/urn:doi:10.1111/bjd.20595 |
| spellingShingle | Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis Papp, Kim A.|||0000-0001-9557-3642 Adult Antibodies, Monoclonal Double-Blind Method Follow-Up Studies Humans Psoriasis Quality of Life Severity of Illness Index Treatment Outcome |
| title | Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis |
| title_full | Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis |
| title_fullStr | Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis |
| title_full_unstemmed | Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis |
| title_short | Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis |
| title_sort | Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis |
| topic | Adult Antibodies, Monoclonal Double-Blind Method Follow-Up Studies Humans Psoriasis Quality of Life Severity of Illness Index Treatment Outcome |
| topic_facet | Adult Antibodies, Monoclonal Double-Blind Method Follow-Up Studies Humans Psoriasis Quality of Life Severity of Illness Index Treatment Outcome |
| url | https://ddd.uab.cat/record/270201 https://dx.doi.org/urn:doi:10.1111/bjd.20595 |