Efficacy and safety of risankizumab versus methotrexate in patients with moderate-to-severe plaque psoriasis: results from IMMbrace, a randomized, double-blind, phase 3 study with an open-label extension period in Brazil
Abstract: Background: Psoriasis, a chronic, inflammatory skin disease, requires long-term therapy. Risankizumab is a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit. Objective: The authors assessed the efficacy and safety of r...
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Sociedade Brasileira de Dermatologia
2025-04-01
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| Series: | Anais Brasileiros de Dermatologia |
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| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0365-05962025000200308&lng=en&tlng=en |
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| author | Tania F. Cestari Cacilda da Silva Souza Luna Azulay-Abulafia Ricardo Romiti André V.E. Carvalho Caio César Silva de Castro Sílvio Alencar Marques João Roberto Antonio Lincoln Fabrício Ahmed M. Soliman Tianshuang Wu Ranjeeta Sinvhal Vassilis Stakias Alexandra P. Song Jasmina Kalabic Naomi Martin Luiza Keiko Matsuka Oyafuso |
| author_facet | Tania F. Cestari Cacilda da Silva Souza Luna Azulay-Abulafia Ricardo Romiti André V.E. Carvalho Caio César Silva de Castro Sílvio Alencar Marques João Roberto Antonio Lincoln Fabrício Ahmed M. Soliman Tianshuang Wu Ranjeeta Sinvhal Vassilis Stakias Alexandra P. Song Jasmina Kalabic Naomi Martin Luiza Keiko Matsuka Oyafuso |
| author_sort | Tania F. Cestari |
| collection | DOAJ |
| description | Abstract: Background: Psoriasis, a chronic, inflammatory skin disease, requires long-term therapy. Risankizumab is a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit. Objective: The authors assessed the efficacy and safety of risankizumab compared with methotrexate in adults with moderate-to-severe plaque psoriasis. Methods: IMMbrace was a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study. Patients received subcutaneous risankizumab 150 mg at weeks 0, 4, and 16 plus oral placebo weekly, or oral methotrexate 5 mg weekly (with dose escalation up to 25 mg based on response and tolerability) plus subcutaneous placebo at weeks 0, 4, and 16. Primary efficacy endpoints were the proportions of patients who achieved ≥ 90% improvement in Psoriasis Area and Severity Index (PASI90) and static Physician’s Global Assessment of clear/almost clear (sPGA 0/1) at week 28. Safety was also assessed. Results: Among 98 patients randomized (risankizumab, n = 50; methotrexate, n = 48), 95 completed the double-blind period. At week 28, significantly higher proportions of patients treated with risankizumab versus methotrexate achieved PASI90 (84.0% vs. 35.4%; p < 0.001); sPGA 0/1 was achieved by 90.0% and 64.6% of patients in the risankizumab and methotrexate groups(p ≤ 0.001). Risankizumab efficacy was maintained throughout week 112. Adverse event rates were similar in the two groups. Study limitations: The sample size was small due to the difficulty of recruiting patients without methotrexate use. Conclusions: Risankizumab demonstrated superior efficacy over methotrexate at week 28; efficacy was maintained, and no new safety findings were observed through week 112. |
| format | Article |
| id | doaj-art-2c070b4d375c4b338a05b8fa85b48238 |
| institution | Kabale University |
| issn | 0365-0596 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Sociedade Brasileira de Dermatologia |
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| series | Anais Brasileiros de Dermatologia |
| spelling | doaj-art-2c070b4d375c4b338a05b8fa85b482382025-08-20T03:52:32ZengSociedade Brasileira de DermatologiaAnais Brasileiros de Dermatologia0365-05962025-04-01100210.1016/j.abd.2024.08.002Efficacy and safety of risankizumab versus methotrexate in patients with moderate-to-severe plaque psoriasis: results from IMMbrace, a randomized, double-blind, phase 3 study with an open-label extension period in BrazilTania F. Cestarihttps://orcid.org/0000-0003-3001-0202Cacilda da Silva Souzahttps://orcid.org/0000-0002-8157-7658Luna Azulay-Abulafiahttps://orcid.org/0000-0002-4698-2009Ricardo Romitihttps://orcid.org/0000-0003-0165-3831André V.E. Carvalhohttps://orcid.org/0000-0002-0407-538XCaio César Silva de Castrohttps://orcid.org/0000-0001-9767-5765Sílvio Alencar Marqueshttps://orcid.org/0000-0002-5512-4700João Roberto Antoniohttps://orcid.org/0000-0002-0268-5934Lincoln Fabríciohttps://orcid.org/0000-0001-9191-1085Ahmed M. Solimanhttps://orcid.org/0009-0008-8632-1396Tianshuang Wuhttps://orcid.org/0009-0007-4205-9579Ranjeeta Sinvhalhttps://orcid.org/0009-0003-1950-9181Vassilis Stakiashttps://orcid.org/0009-0006-2628-0399Alexandra P. Songhttps://orcid.org/0000-0002-8344-6651Jasmina Kalabichttps://orcid.org/0009-0007-4698-1042Naomi Martinhttps://orcid.org/0009-0006-9169-8791Luiza Keiko Matsuka Oyafusohttps://orcid.org/0000-0003-3982-3322Abstract: Background: Psoriasis, a chronic, inflammatory skin disease, requires long-term therapy. Risankizumab is a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit. Objective: The authors assessed the efficacy and safety of risankizumab compared with methotrexate in adults with moderate-to-severe plaque psoriasis. Methods: IMMbrace was a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study. Patients received subcutaneous risankizumab 150 mg at weeks 0, 4, and 16 plus oral placebo weekly, or oral methotrexate 5 mg weekly (with dose escalation up to 25 mg based on response and tolerability) plus subcutaneous placebo at weeks 0, 4, and 16. Primary efficacy endpoints were the proportions of patients who achieved ≥ 90% improvement in Psoriasis Area and Severity Index (PASI90) and static Physician’s Global Assessment of clear/almost clear (sPGA 0/1) at week 28. Safety was also assessed. Results: Among 98 patients randomized (risankizumab, n = 50; methotrexate, n = 48), 95 completed the double-blind period. At week 28, significantly higher proportions of patients treated with risankizumab versus methotrexate achieved PASI90 (84.0% vs. 35.4%; p < 0.001); sPGA 0/1 was achieved by 90.0% and 64.6% of patients in the risankizumab and methotrexate groups(p ≤ 0.001). Risankizumab efficacy was maintained throughout week 112. Adverse event rates were similar in the two groups. Study limitations: The sample size was small due to the difficulty of recruiting patients without methotrexate use. Conclusions: Risankizumab demonstrated superior efficacy over methotrexate at week 28; efficacy was maintained, and no new safety findings were observed through week 112.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0365-05962025000200308&lng=en&tlng=enMethotrexatePsoriasisRisankizumab |
| spellingShingle | Tania F. Cestari Cacilda da Silva Souza Luna Azulay-Abulafia Ricardo Romiti André V.E. Carvalho Caio César Silva de Castro Sílvio Alencar Marques João Roberto Antonio Lincoln Fabrício Ahmed M. Soliman Tianshuang Wu Ranjeeta Sinvhal Vassilis Stakias Alexandra P. Song Jasmina Kalabic Naomi Martin Luiza Keiko Matsuka Oyafuso Efficacy and safety of risankizumab versus methotrexate in patients with moderate-to-severe plaque psoriasis: results from IMMbrace, a randomized, double-blind, phase 3 study with an open-label extension period in Brazil Anais Brasileiros de Dermatologia Methotrexate Psoriasis Risankizumab |
| title | Efficacy and safety of risankizumab versus methotrexate in patients with moderate-to-severe plaque psoriasis: results from IMMbrace, a randomized, double-blind, phase 3 study with an open-label extension period in Brazil |
| title_full | Efficacy and safety of risankizumab versus methotrexate in patients with moderate-to-severe plaque psoriasis: results from IMMbrace, a randomized, double-blind, phase 3 study with an open-label extension period in Brazil |
| title_fullStr | Efficacy and safety of risankizumab versus methotrexate in patients with moderate-to-severe plaque psoriasis: results from IMMbrace, a randomized, double-blind, phase 3 study with an open-label extension period in Brazil |
| title_full_unstemmed | Efficacy and safety of risankizumab versus methotrexate in patients with moderate-to-severe plaque psoriasis: results from IMMbrace, a randomized, double-blind, phase 3 study with an open-label extension period in Brazil |
| title_short | Efficacy and safety of risankizumab versus methotrexate in patients with moderate-to-severe plaque psoriasis: results from IMMbrace, a randomized, double-blind, phase 3 study with an open-label extension period in Brazil |
| title_sort | efficacy and safety of risankizumab versus methotrexate in patients with moderate to severe plaque psoriasis results from immbrace a randomized double blind phase 3 study with an open label extension period in brazil |
| topic | Methotrexate Psoriasis Risankizumab |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0365-05962025000200308&lng=en&tlng=en |
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