ArticleAnnals of the rheumatic diseases2021
New composite endpoint in early diffuse cutaneous systemic sclerosis: revisiting the provisional American College of Rheumatology Composite Response Index in Systemic Sclerosis.
Article in Annals of the rheumatic diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 33 papers.
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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.
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Who cites it
33 citing papers in PubMed, 61 citations in OpenAlex.
- CD19 CAR-T cells for treatment-refractory autoimmune diseases: the phase 1/2 CASTLE basket trial.Nature medicine · 2026Trial
- Belumosudil in diffuse cutaneous systemic sclerosis: a randomized, double-blind, open-label extension, placebo-controlled, phase 2 study.Rheumatology (Oxford, England) · 2025Trial
- Mesenchymal Stem Cell Therapy for Systemic Sclerosis: Current Evidence and Clinical Applications.Stem cell reviews and reports · 2026Review
- Review
- Discordance Between Patient and Physician Global Assessments in Early Systemic Sclerosis.Arthritis care & research · 2026Article
- Case study of resecabtagene autoleucel in a subject with diffuse cutaneous systemic sclerosis treated in the RESET-SSc trial.Molecular therapy. Advances · 2026Article
- CAR-T therapy for autoimmune rheumatic diseases: navigating clinical frontiers between breakthroughs and uncertainties.Clinical and experimental medicine · 2026Review
- Clinical features and management of LICATS involving the heart in a patient with diffuse and rapidly progressive systemic sclerosis.EULAR rheumatology open · 2026Article
- Are we ready to predict progressive disease in juvenile systemic sclerosis?Journal of scleroderma and related disorders · 2026Article
- 'Am I doing this right?' Physician perceptions of the global assessment in clinical trials of systemic sclerosis.Rheumatology (Oxford, England) · 2025Article
- Observational
- Development of a conceptual model of early systemic sclerosis (scleroderma).Orphanet journal of rare diseases · 2025Article
- Validation and cross-cultural adaptation of the Thai version of the Systemic Sclerosis Health Assessment Questionnaire.Clinical rheumatology · 2025Article
- Serum type I interferon score as a disease activity biomarker in patients with diffuse cutaneous systemic sclerosis: a retrospective cohort study.The Lancet. Rheumatology · 2025Article
- Neural network analysis as a novel skin outcome in a trial of belumosudil in patients with systemic sclerosis.Arthritis research & therapy · 2025Article
- An international perspective on the future of systemic sclerosis research.Nature reviews. Rheumatology · 2025Review
- Comparison of Three Physician Global Assessment Instruments in Systemic Sclerosis.Arthritis care & research · 2025Article
- Does regression of skin thickening predict improvement of internal organ involvement and survival in patients with diffuse cutaneous systemic sclerosis? A EUSTAR analysis.Arthritis research & therapy · 2024Article
- Can machine learning assist in systemic sclerosis diagnosis and management? A scoping review.Journal of scleroderma and related disorders · 2024Article
- Skin Ultrasound Assessment of Patients with Systemic Scleroderma-An Observational Study.Journal of personalized medicine · 2024Article
Corrections and comments
- Erratum issuedCorrection:2021
Authors and funding
4 authors at 1 institution in 1 country.
Funding
Abstract
objectivesAmerican College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) is a composite endpoint to assess the likelihood of improvement in diffuse systemic sclerosis. ACR-CRISS is a weighted score and includes five core set measures: modified Rodnan skin score, FVC% predicted, health assessment questionnaire-disability index, and patient and clinician global assessments.
methodsWe analysed core set measures from 354 participants who participated in three placebo-controlled trials. We generated 10 development datasets, randomly selected from 2/3 of the participants, stratified by study and treatment group. The remaining participants (1/3 of the participants) formed the validation sets. Risk differences (RDs) between active and placebo treatments were calculated by averaging over the replicate datasets; bootstrap 95% CIs for the RDs to estimate the magnitude of treatment effects.
resultsIn the development sets (n=237), the proportion of participants in the active group had statistically higher improvement in >1 of 5 core set measures versus the placebo group. For example, the proportion who improved by ≥20% in ≥3 core set measures was 49.4% in the active versus338.9% in the placebo; RD: 10.5%, 95% CI4.9 % to 16.1%. In the validation sets (n=117), the proportion who improved by ≥20% in ≥3 core set measures was 50.3% in the active versus35.63% in the placebo (RD:114.8%, 95% CI 3.1% to225.7%). Similar trends were seen with larger percentage cut-offs.
conclusionRevised CRISS, as assessed by the proportion of participants who improved by a certain percentage in ≥3 of 5 core set measures, is a potential new composite outcome measure.
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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.