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Peer-reviewedCC BY 4.0Frontiers in Immunology

Effectiveness and drug survival of adalimumab across clinical phenotypes of Behçet’s syndrome: an exploratory real-world cohort study

Abstract

ObjectiveTo describe treatment response, drug retention, and exploratory phenotype-related patterns of response to adalimumab in a real-world cohort of patients with Behçet’s syndrome.MethodsWe conducted a single-center, single-arm retrospective cohort study including adult patients with Behçet’s syndrome treated with adalimumab at a tertiary referral center between 2004 and 2024. Disease activity was assessed using the Behçet’s Disease Current Activity Form (BDCAF). Clinical phenotypes were defined post hoc according to baseline organ involvement. All phenotype-based and predictor analyses were considered exploratory. Outcomes included treatment retention, changes in BDCAF score, clinical response rates, phenotype-specific response, safety, and exploratory predictors of primary non-response and treatment discontinuation.ResultsNinety-two patients were included (66.3% female; mean disease duration 17.0 ± 6 years; mean follow-up duration after ADA initiation 36.7 ± 38.6 months). Among the 42 patients with complete paired BDCAF data available for response assessment, mean BDCAF decreased from 6.2 to 0.7 (p<0.001), and 34 patients (81.0%) achieved complete remission. Median drug retention was 41 months, with retention rates of 77.6% at 1 year, 51.7% at 3 years, and 41.4% at 5 years. Half of patients discontinued treatment over time, mainly due to secondary loss of efficacy. Response rates were numerically higher in the ocular-predominant phenotype (72.2%). Analyses of baseline features suggested a possible signal for anterior uveitis; however, these findings should be interpreted as hypothesis-generating. Adverse events occurred in 13.0% of patients, most commonly hypersensitivity and injection-site reactions. No serious adverse events were recorded.ConclusionsAdalimumab was associated with reduced disease activity in this real-world cohort, although long-term persistence was limited. Differences across clinical phenotypes were descriptive and hypothesis-generating, with numerically higher response rates in ocular-predominant disease. These findings require confirmation in prospective multicenter studies using organ-specific outcome measures.

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BibTeX
@article{talarico2026effectiveness,
  title = {{Effectiveness and drug survival of adalimumab across clinical phenotypes of Behçet’s syndrome: an exploratory real-world cohort study}},
  author = {Rosaria Talarico and Federica Di Cianni and Antonello Sulis and Diana Marinello and Maria Laura Manca and Marta Mosca},
  journal = {Frontiers in Immunology},
  year = {2026},
  month = nov,
  doi = {10.3389/fimmu.2026.1872979},
  url = {https://www.frontiersin.org/articles/10.3389/fimmu.2026.1872979},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Effectiveness and drug survival of adalimumab across clinical phenotypes of Behçet’s syndrome: an exploratory real-world cohort study
AU  - Rosaria Talarico
AU  - Federica Di Cianni
AU  - Antonello Sulis
AU  - Diana Marinello
AU  - Maria Laura Manca
AU  - Marta Mosca
PY  - 2026
DA  - 2026/11/05
JO  - Frontiers in Immunology
DO  - 10.3389/fimmu.2026.1872979
UR  - https://www.frontiersin.org/articles/10.3389/fimmu.2026.1872979
AB  - ObjectiveTo describe treatment response, drug retention, and exploratory phenotype-related patterns of response to adalimumab in a real-world cohort of patients with Behçet’s syndrome.MethodsWe conducted a single-center, single-arm retrospective cohort study including adult patients with Behçet’s syndrome treated with adalimumab at a tertiary referral center between 2004 and 2024. Disease activity was assessed using the Behçet’s Disease Current Activity Form (BDCAF). Clinical phenotypes were defined post hoc according to baseline organ involvement. All phenotype-based and predictor analyses were considered exploratory. Outcomes included treatment retention, changes in BDCAF score, clinical response rates, phenotype-specific response, safety, and exploratory predictors of primary non-response and treatment discontinuation.ResultsNinety-two patients were included (66.3% female; mean disease duration 17.0 ± 6 years; mean follow-up duration after ADA initiation 36.7 ± 38.6 months). Among the 42 patients with complete paired BDCAF data available for response assessment, mean BDCAF decreased from 6.2 to 0.7 (p<0.001), and 34 patients (81.0%) achieved complete remission. Median drug retention was 41 months, with retention rates of 77.6% at 1 year, 51.7% at 3 years, and 41.4% at 5 years. Half of patients discontinued treatment over time, mainly due to secondary loss of efficacy. Response rates were numerically higher in the ocular-predominant phenotype (72.2%). Analyses of baseline features suggested a possible signal for anterior uveitis; however, these findings should be interpreted as hypothesis-generating. Adverse events occurred in 13.0% of patients, most commonly hypersensitivity and injection-site reactions. No serious adverse events were recorded.ConclusionsAdalimumab was associated with reduced disease activity in this real-world cohort, although long-term persistence was limited. Differences across clinical phenotypes were descriptive and hypothesis-generating, with numerically higher response rates in ocular-predominant disease. These findings require confirmation in prospective multicenter studies using organ-specific outcome measures.
SN  - 1664-3224
ER  -