ArticleThe journal of allergy and clinical immunology. Global2025
Treatment of indolent systemic mastocytosis with sarilumab is not supported in a randomized trial.
Article in The journal of allergy and clinical immunology. Global, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03770273 (A Phase 2 Randomized Double-Blinded Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in Subjects With Indolent Systemic Mastocytosis), which is not on this map. Cited by 1 paper.
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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.
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A Phase 2 Randomized Double-Blinded Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in Subjects With Indolent Systemic Mastocytosis
Who cites it
1 citing paper in PubMed.
- Investigational Approaches in Treatment of Nonadvanced Mastocytosis.Current allergy and asthma reports · 2026Review
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Indolent systemic mastocytosis is a clonal mast cell disease that results in an increase in mast cells in the skin, bone marrow, and other organ systems. IL-6 has been shown to promote mast cell maturation, proliferation, and reactivity Objective: We conducted a double-blind placebo-controlled study to assess safety and efficacy for the use of sarilumab in improving the quality of life for those with indolent systemic mastocytosis. ClinicalTrial.gov registration NCT03770273. Methods: A double-blind trial randomized 16 participants. The primary analysis compared the arms on the Mastocytosis Quality of Life Questionnaire (MC-QoL) index at 16 weeks, adjusting for the baseline MC-QoL. Mean baseline MC-QoL was 47.8. Results: The difference between the arms in the primary analysis was not statistically significant, with the results favoring the placebo arm; mean absolute MC-QoL improvement in the placebo arm was 14.7 relative to 8.9 in the sarilumab arm. The estimated treatment effect from regression analysis was a 6.0-unit advantage of MC-QoL in the placebo arm ( Conclusions: Results in this small trial did not support using sarilumab to treat this population and highlights the importance of double-blind randomized studies.
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