Trial reportAnnals of the rheumatic diseases2011
Imatinib mesylate (Gleevec) in the treatment of diffuse cutaneous systemic sclerosis: results of a 1-year, phase IIa, single-arm, open-label clinical trial.
Trial report in Annals of the rheumatic diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00555581 (Phase IIA Study of the Safety and Tolerability of the Use of Imatinib Mesylate), which is not on this map. Cited by 74 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Phase IIA Study of the Safety and Tolerability of the Use of Imatinib Mesylate (Gleevec) in the Treatment of Systemic Sclerosis
Who cites it
74 citing papers in PubMed, 2 syntheses or guidelines pooled it, 174 citations in OpenAlex.
- Pulmonary function tests as outcomes for systemic sclerosis interstitial lung disease.European respiratory review : an official journal of the European Respiratory Society · 2018Pooled it
- Systemic sclerosis: a systematic review on therapeutic management from 2011 to 2014.Current opinion in rheumatology · 2015Pooled it
- Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate).Annals of the rheumatic diseases · 2018Trial
- Proteomic Analysis of Sera from Individuals with Diffuse Cutaneous Systemic Sclerosis Reveals a Multianalyte Signature Associated with Clinical Improvement during Imatinib Mesylate Treatment.The Journal of rheumatology · 2017Trial
- Nilotinib (Tasigna™) in the treatment of early diffuse systemic sclerosis: an open-label, pilot clinical trial.Arthritis research & therapy · 2015Trial
- Low-dose oral imatinib in the treatment of systemic sclerosis interstitial lung disease unresponsive to cyclophosphamide: a phase II pilot study.Arthritis research & therapy · 2014Trial
- Macrophage plasticity in thyroid eye disease: dual effects of inflammation and fibrosis.Frontiers in immunology · 2026Review
- Understanding the Mechanisms Driving Fibrosis Following Cochlear Implantation-Lessons from Other Tissues.Cells · 2025Review
- Excessive concentrations of kinase inhibitors in translational studies impede effective drug repurposing.Cell reports. Medicine · 2023Article
- Three Distinct Transcriptional Profiles of Monocytes Associate with Disease Activity in Scleroderma Patients.Arthritis & rheumatology (Hoboken, N.J.) · 2023Article
- Impact of lung function and baseline clinical characteristics on patient-reported outcome measures in systemic sclerosis-associated interstitial lung disease.Rheumatology (Oxford, England) · 2023Article
- Perspective to precision medicine in scleroderma.Frontiers in immunology · 2023Article
- Clinical Treatment Options in Scleroderma: Recommendations and Comprehensive Review.Clinical reviews in allergy & immunology · 2022Review
- Future Treatment Options in Systemic Sclerosis-Potential Targets and Ongoing Clinical Trials.Journal of clinical medicine · 2022Review
- Therapeutic Options for Systemic Sclerosis: Current and Future Perspectives in Tackling Immune-Mediated Fibrosis.Biomedicines · 2022Review
- Parkinson's Disease Modification Through Abl Kinase Inhibition: An Opportunity.Movement disorders : official journal of the Movement Disorder Society · 2022Review
- Targeting Dermal Fibroblast Subtypes in Antifibrotic Therapy: Surface Marker as a Cellular Identity or a Functional Entity?Frontiers in physiology · 2021Review
- Skin Histology in Systemic Sclerosis: a Relevant Clinical Biomarker.Current rheumatology reports · 2020Review
- The need for a holistic approach for SSc-ILD - achievements and ambiguity in a devastating disease.Respiratory research · 2020Review
- Treatment in Juvenile Scleroderma.Current rheumatology reports · 2020Review
14 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveTo assess the safety and effectiveness of imatinib mesylate in the treatment of diffuse cutaneous systemic sclerosis (dcSSc).
methodsIn this phase IIa, open-label, single-arm clinical trial, 30 patients with dcSSc were treated with imatinib 400 mg daily. Patients were monitored monthly for safety assessments. Modified Rodnan skin scores (MRSS) were assessed every 3 months. Pulmonary function testing, chest radiography, echocardiography and skin biopsies were performed at baseline and after 12 months of treatment.
resultsTwenty-four patients completed 12 months of therapy. 171 adverse events (AE) with possible relation to imatinib were identified; 97.6% were grade 1 or 2. Twenty-four serious AE were identified, two of which were attributed to study medication. MRSS decreased by 6.6 points or 22.4% at 12 months (p=0.001). This change was evident starting at the 6-month time point (Δ=-4.5; p<0.001) and was seen in patients with both early and late-stage disease. Forced vital capacity (FVC) improved by 6.4% predicted (p=0.008), and the diffusion capacity remained stable. The improvement in FVC was significantly greater in patients without interstitial lung disease. Health-related quality of life measures improved or remained stable. Blinded dermatopathological analysis confirmed a significant decrease in skin thickness and improvement in skin morphology.
conclusionsTreatment with imatinib was tolerated by most patients in this cohort. Although AE were common, most were mild to moderate. In this open-label experience, improvements in skin thickening and FVC were observed. Further investigation of tyrosine kinase inhibition for dcSSc in a double-blind randomised placebo controlled trial is warranted. ClinicalTrials.gov, NCT00555581.
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Registered trials
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.