Trial reportArthritis research & therapy2017
Treatment of mucocutaneous manifestations in Behçet's disease with anakinra: a pilot open-label study.
Trial report in Arthritis research & therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01441076 (A Pilot Study of Anakinra in Behcet's Disease), which is not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Pilot Study of Anakinra in Behcet's Disease (BD)
Who cites it
24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 68 citations in OpenAlex.
- Systematic Review of Safety and Efficacy of IL-1-Targeted Biologics in Treating Immune-Mediated Disorders.Frontiers in immunology · 2022Pooled it
- Interleukin-1 blockade treatment decreasing cardiovascular risk.Clinical cardiology · 2019Pooled it
- The right place of interleukin-1 inhibitors in the treatment of Behçet's syndrome: a systematic review.Rheumatology international · 2019Pooled it
- Impact of apremilast on quality of life in Behçet's syndrome: analysis of the phase 3 RELIEF study.RMD open · 2022Trial
- The IL-23/IL-17 axis in Behçet's syndrome pathogenesis: from immunological perspectives to therapeutic implications.Frontiers in immunology · 2026Review
- Single Center-Based Real-World Experience on Anti-IL 1 Biological Response Modifiers: A Case Series and Literature Review.Children (Basel, Switzerland) · 2024Article
- Treatment Options in Pediatric Behçet's Disease.Paediatric drugs · 2023Review
- Paediatric Behçet's Disease: A Comprehensive Review with an Emphasis on Monogenic Mimics.Journal of clinical medicine · 2022Review
- The Th17 Pathway in Vascular Inflammation: Culprit or Consort?Frontiers in immunology · 2022Review
- New insights on multigenic autoinflammatory diseases.Therapeutic advances in musculoskeletal disease · 2022Review
- Biologic treatments in Behçet's disease.European journal of rheumatology · 2021Article
- Behçet Disease: An Update for Dermatologists.American journal of clinical dermatology · 2021Review
- Advances in the Treatment of Behcet's Disease.Current rheumatology reports · 2021Review
- The One That Got Away: How Macrophage-Derived IL-1β Escapes the Mycolactone-Dependent Sec61 Blockade in Buruli Ulcer.Frontiers in immunology · 2021Article
- Understanding Behçet's Disease in the Context of Innate Immunity Activation.Frontiers in immunology · 2020Review
- Interleukin-1 Blockade in Polygenic Autoinflammatory Disorders: Where Are We now?Frontiers in pharmacology · 2020Review
- Pathophysiology and therapy of systemic vasculitides.EXCLI journal · 2020Review
- Phenotypes in Behçet's syndrome.Internal and emergency medicine · 2019Review
- Update on the treatment of Behçet's syndrome.Internal and emergency medicine · 2019Review
- Treating the Different Phenotypes of Behçet's Syndrome.Frontiers in immunology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundThe effect of IL-1 blocking therapy on mucocutaneous manifestations of Behçet's disease is incompletely understood.
methodsSix patients with Behçet's disease and ongoing oral/genital ulcers for ≥1 month were enrolled into an adaptive, two-phase clinical trial and included in the analysis. Study duration was 6 months with extension up to 16 months. All were treated non-blinded with anakinra 100 mg subcutaneous daily with the option to escalate the dose to 200 mg in partial responders after 1 month and 300 mg after 6 months. Patients recorded the number and severity of ulcers in daily diaries. The primary outcome was remission defined as no ulcers on physical exam for two consecutive monthly visits between months 3 and 6. Secondary outcomes included the number and severity of patient-reported ulcers, patient/physician global scores, and standardized disease activity scores.
resultsTwo of six patients achieved the primary outcome. Five of six patients had improvement in the number and severity of ulcers. Non-statistically significant improvements were seen in secondary outcomes. Over the entire study, patients reported ≥1 oral and ≥1 genital ulcer on 665 (66%) and 139 (14%) days, respectively. On anakinra 200 mg vs 100 mg, patients reported fewer days with oral ulcers (65% vs 74% of days, p = 0.01) and genital ulcers (10% vs 22% of days, p < 0.001) and milder oral ulcer severity (p < 0.001). Increase of anakinra to 300 mg did not result in further improvements. Adverse events were notable for mild infections.
conclusionAnakinra at an optimal dose of 200 mg daily had an acceptable safety profile and was partially effective in the treatment of resistant oral and genital ulcers in Behçet's disease.
trial registrationClinicaltrials.gov. NCT01441076 . Registered on 24 September 2011.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.