Tildrakizumab for the treatment of moderate-to-severe psoriasis: a 52-week, real-world Portuguese multicentric study
Background: Real-world evidence plays a pivotal role in validating the efficacy of biologic drugs beyond the controlled environment of randomized trials. This study aimed to evaluate the effectiveness of tildrakizumab in treating moderate-to-severe psoriasis within a real-world setting over a 52-wee...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BioExcel Publishing Ltd
2024-03-01
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| Series: | Drugs in Context |
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| Online Access: | https://www.drugsincontext.com/tildrakizumab-for-the-treatment-of-moderate-to-severe-psoriasis-a-52-week-real-world-portuguese-multicentric-study/ |
| _version_ | 1827315293202939904 |
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| author | Tiago Torres Paulo Varela Pedro Mendes Bastos Sofia Magina Martinha Henrique Paulo Ferreira |
| author_facet | Tiago Torres Paulo Varela Pedro Mendes Bastos Sofia Magina Martinha Henrique Paulo Ferreira |
| author_sort | Tiago Torres |
| collection | DOAJ |
| description | Background: Real-world evidence plays a pivotal role in validating the efficacy of biologic drugs beyond the controlled environment of randomized trials. This study aimed to evaluate the effectiveness of tildrakizumab in treating moderate-to-severe psoriasis within a real-world setting over a 52-week period in Portugal.
Methods: This multicentric, prospective, observational study included adult patients with moderate-to-severe psoriasis. All participants received tildrakizumab 100 mg at weeks 0 and 4, followed by a maintenance dose every 12 weeks, and were monitored for 52 weeks. Primary endpoints were determined based on Psoriasis Area and Severity Index (PASI) assessments at baseline, 16 (±2) weeks, 28 (±2) weeks and 52 (±2) weeks.
Results: A total of 54 patients were enrolled in the study (56% men, mean age of 50.3 ± 14.4 years). Half of the sample (n=27) had no prior experience with biologic treatments. About 74% of patients (n=40) presented at least one comorbidity during the study, with psoriatic arthritis being the most prevalent (29.6%). By week 52, there was a significant decrease in the mean PASI from 17.8±10.3 at baseline to 1.3±1.9 (p<0.001), indicating an overall improvement of 93%. By week 52, more than 85% of patients attained PASI ≤5, more than 80% reached PASI ≤3, and nearly 60% achieved PASI ≤1. Infections were observed in 9.3% of patients, and one patient required hospitalization (1.9%). The cumulative proportion of patients continuing treatment at 52 weeks was 88.9%.
Conclusions: This study demonstrates that tildrakizumab is an effective and safe agent for the treatment of moderateto- severe psoriasis in a diverse, real-world setting. |
| first_indexed | 2024-04-24T22:51:39Z |
| format | Article |
| id | doaj.art-b64f129edde14f9099b20327f9b0d5bd |
| institution | Directory Open Access Journal |
| issn | 1740-4398 |
| language | English |
| last_indexed | 2024-04-24T22:51:39Z |
| publishDate | 2024-03-01 |
| publisher | BioExcel Publishing Ltd |
| record_format | Article |
| series | Drugs in Context |
| spelling | doaj.art-b64f129edde14f9099b20327f9b0d5bd2024-03-18T10:30:44ZengBioExcel Publishing LtdDrugs in Context1740-43982024-03-011311010.7573/dic.2023-12-5Tildrakizumab for the treatment of moderate-to-severe psoriasis: a 52-week, real-world Portuguese multicentric studyTiago TorresPaulo VarelaPedro Mendes BastosSofia MaginaMartinha HenriquePaulo FerreiraBackground: Real-world evidence plays a pivotal role in validating the efficacy of biologic drugs beyond the controlled environment of randomized trials. This study aimed to evaluate the effectiveness of tildrakizumab in treating moderate-to-severe psoriasis within a real-world setting over a 52-week period in Portugal. Methods: This multicentric, prospective, observational study included adult patients with moderate-to-severe psoriasis. All participants received tildrakizumab 100 mg at weeks 0 and 4, followed by a maintenance dose every 12 weeks, and were monitored for 52 weeks. Primary endpoints were determined based on Psoriasis Area and Severity Index (PASI) assessments at baseline, 16 (±2) weeks, 28 (±2) weeks and 52 (±2) weeks. Results: A total of 54 patients were enrolled in the study (56% men, mean age of 50.3 ± 14.4 years). Half of the sample (n=27) had no prior experience with biologic treatments. About 74% of patients (n=40) presented at least one comorbidity during the study, with psoriatic arthritis being the most prevalent (29.6%). By week 52, there was a significant decrease in the mean PASI from 17.8±10.3 at baseline to 1.3±1.9 (p<0.001), indicating an overall improvement of 93%. By week 52, more than 85% of patients attained PASI ≤5, more than 80% reached PASI ≤3, and nearly 60% achieved PASI ≤1. Infections were observed in 9.3% of patients, and one patient required hospitalization (1.9%). The cumulative proportion of patients continuing treatment at 52 weeks was 88.9%. Conclusions: This study demonstrates that tildrakizumab is an effective and safe agent for the treatment of moderateto- severe psoriasis in a diverse, real-world setting.https://www.drugsincontext.com/tildrakizumab-for-the-treatment-of-moderate-to-severe-psoriasis-a-52-week-real-world-portuguese-multicentric-study/biologiceffectivenessil-23psoriasisrealworldsafetytildrakizumab |
| spellingShingle | Tiago Torres Paulo Varela Pedro Mendes Bastos Sofia Magina Martinha Henrique Paulo Ferreira Tildrakizumab for the treatment of moderate-to-severe psoriasis: a 52-week, real-world Portuguese multicentric study Drugs in Context biologic effectiveness il-23 psoriasis realworld safety tildrakizumab |
| title | Tildrakizumab for the treatment of moderate-to-severe psoriasis: a 52-week, real-world Portuguese multicentric study |
| title_full | Tildrakizumab for the treatment of moderate-to-severe psoriasis: a 52-week, real-world Portuguese multicentric study |
| title_fullStr | Tildrakizumab for the treatment of moderate-to-severe psoriasis: a 52-week, real-world Portuguese multicentric study |
| title_full_unstemmed | Tildrakizumab for the treatment of moderate-to-severe psoriasis: a 52-week, real-world Portuguese multicentric study |
| title_short | Tildrakizumab for the treatment of moderate-to-severe psoriasis: a 52-week, real-world Portuguese multicentric study |
| title_sort | tildrakizumab for the treatment of moderate to severe psoriasis a 52 week real world portuguese multicentric study |
| topic | biologic effectiveness il-23 psoriasis realworld safety tildrakizumab |
| url | https://www.drugsincontext.com/tildrakizumab-for-the-treatment-of-moderate-to-severe-psoriasis-a-52-week-real-world-portuguese-multicentric-study/ |
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