Trial reportAnnals of medicine2024
Long-term safety of mepolizumab for up to ∼10 years in patients with severe asthma: open-label extension study.
Trial report in Annals of medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00244686 (104317), which is not on this map. Cited by 15 papers.
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.
104317: An Open-Label Compassionate Use Access and Long-Term Access Study of Anti IL-5 (Mepolizumab) Treatment in Subjects With Hypereosinophilic Syndrome. 201956: A Long-term Access Programme for Subjects With Severe Asthma Who Participated in a GSK-sponsored Mepolizumab Clinical Study. 112562: Expanded Access to Mepolizumab for Patients With Hypereosinophilic Syndrome
Who cites it
15 citing papers in PubMed.
- Safety and Tolerability of Twice-Yearly Depemokimab in Patients with Asthma and Chronic Rhinosinusitis with Nasal Polyps: Pooled Results from SWIFT-1/-2 and ANCHOR-1/-2.Advances in therapy · 2026Trial
- Long-Term Safety and Efficacy of Mepolizumab in Eosinophilic Granulomatosis With Polyangiitis.Arthritis & rheumatology (Hoboken, N.J.) · 2025Trial
- Incidence of New Malignancies in Severe Asthma: Comparison of Real-World Patients Treated with Benralizumab, Other Biologics, or Non-biologics.Pulmonary therapy · 2026Article
- Review
- Straight to Phase III: Model-Informed Approach Speeds Depemokimab Clinical Development in Interleukin-5-Driven Diseases.Clinical pharmacology and therapeutics · 2026Article
- Dupilumab Versus Mepolizumab for COPD: Evaluating Efficacy Outcomes Using Placebo-Adjusted Indirect Treatment Comparison.Pulmonary therapy · 2026Article
- Rethinking asthma therapy, part 2: transdermal strategies for adjunct asthma and allergy treatments.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2026Review
- Mepolizumab in Pediatric Severe Eosinophilic Asthma: A Review of Efficacy, Safety, and Clinical Applications.Journal of inflammation research · 2026Review
- Biologic therapies for severe pediatric asthma: efficacy, safety, and biomarker-guided selection.Frontiers in allergy · 2026Review
- Recent Developments in Monoclonal-Antibody-Based Biologic Therapy for Severe Refractory Eosinophilic Asthma.Antibodies (Basel, Switzerland) · 2025Review
- Safety and tolerability of astegolimab, an anti-ST2 monoclonal antibody: a narrative review.Respiratory research · 2025Review
- Biologic Therapies for Severe Asthma: Current Insights and Future Directions.Journal of clinical medicine · 2025Review
- Severe Asthma in School-Age Children: An Updated Appraisal on Biological Options and Challenges in This Age Group.Children (Basel, Switzerland) · 2025Review
- Mepolizumab for hypereosinophilic syndrome: effectiveness and safety from real-world evidence.Frontiers in immunology · 2025Article
- Targeting Eosinophils in Asthmatic Inflammation: Benefits and Drawbacks.Journal of inflammation research · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesLong-term safety monitoring of mepolizumab is necessary to support real-world use for the treatment of severe asthma. This Long-Term Access Program assessed the safety and benefit:risk of mepolizumab in pediatric, adolescent, and adult patients with severe asthma. MATERIALS AND
methodsThis was a multicenter, Phase IIIb safety, open-label extension study of multiple prior studies assessing mepolizumab in addition to standard of care (Aug 2015 - Aug 2022). Adults/adolescents (≥12 years of age) received mepolizumab 100 mg subcutaneously (SC) every 4 weeks until mepolizumab was commercialized. Pediatric patients (6-11 years of age) received mepolizumab 40 mg or 100 mg SC (bodyweight <40 or ≥40 kg, respectively) every 4 weeks. Safety was assessed every 4 weeks and benefit:risk every 12 weeks.
resultsOf the 514 patients enrolled, 57% were female and the mean age was 51.1 (standard deviation: 14.9) years; 24 (5%) patients were 6-17 years of age. Total cumulative mepolizumab exposure across all mepolizumab studies included in this analysis was 1500.59 patient-years; median exposure was 2.03 (range, 0.08 to 9.97) years. Overall, 37 (7%) patients experienced on-treatment serious adverse events (SAEs): 34/502 (7%) in the 100 mg SC group and 3/7 (43%) in the 40 mg SC pediatric group. Two patients experienced SAEs considered to be treatment-related by the investigator. Infections were the most common SAEs of special interest (9 [2%] patients). Physician-assessed benefit:risk of mepolizumab supported continued treatment over the study period.
conclusionsThis long-term safety analysis of mepolizumab was consistent with previous reports, with no emerging safety concerns; most patients had a favorable benefit:risk up to ∼10 years. CLINICAL TRIAL IDENTIFIER: NCT00244686 (GSK ID 201956).
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