Trial reportRheumatology (Oxford, England)2015
Second-line agents in myositis: 1-year factorial trial of additional immunosuppression in patients who have partially responded to steroids.
Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in Rheumatology (Oxford, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 3 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 pooled it
1.5field-weighted citation impact, top 17% of its field
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 3 syntheses or guidelines pooled it, 28 citations in OpenAlex.
- Non-targeted immunosuppressive and immunomodulatory therapies for idiopathic inflammatory myopathies.The Cochrane database of systematic reviews · 2025Pooled it
- Targeted immunosuppressive and immunomodulatory therapies for idiopathic inflammatory myopathies.The Cochrane database of systematic reviews · 2025Pooled it
- The evidence for immunotherapy in dermatomyositis and polymyositis: a systematic review.Clinical rheumatology · 2015Pooled it
- [Dermatomyositis and juvenile dermatomyositis].Zeitschrift fur Rheumatologie · 2023Review
- Treatment of adult idiopathic inflammatory myopathies with conventional immunosuppressive drugs : Results of a retrospective study.Zeitschrift fur Rheumatologie · 2019Article
- Autoimmune Myopathies: Updates on Evaluation and Treatment.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2018Review
- Idiopathic inflammatory myopathies-a review.Clinical rheumatology · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 4 institutions in 1 country.
Fowzia IbrahimDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK fowzia.ibrahim@kcl.ac.uk.
Ernest ChoyDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
Patrick GordonDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
Caroline J DoréDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
Alan HakimDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
George KitasDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
David IsenbergDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
Bridget GriffithsDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
Bryan LeckyDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
Kuntal ChakravartyDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
John WinerDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
Katalin DankoDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
Robert G CooperDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
Beverley White-AlaoDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
David L ScottDepartment of Rheumatology, King's College London, London, Cardiff Institute of Infection & Immunity, Cardiff University School of Medicine, Cardiff, MRC Clinical Trials Unit, Department of Rheumatology, Whipps Cross University Hospital, London, Rheumatology, Russells Hall Hospital, Dudley Group of Hospitals NHS Foundation Trust, Dudley, Department of Rheumatology, University College London Hospitals, London, Musculoskeletal Unit, Freeman Hospital, Newcastle, Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, Department of Rheumatology, Queen's Hospital, Romford, Department of Neurology, The Queen Elizabeth Hospital Neuroscience Centre, Birmingham, UK, Department of Internal Medicine, Medical University of Debrecen, Debrecen, Hungary and Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust, Manchester, UK.
Salford Royal NHS Foundation Trust · GBWhipps Cross University Hospital · GBRussells Hall Hospital · GBUniversity College London · GB
Funding
Medical Research Council MC_U122886349Medical Research Council MC_UU_12023/14Medical Research Council MR/K006312/1Versus Arthritis 18474
Abstract
objectiveCiclosporin and MTX are used in idiopathic inflammatory myopathies (DM and PM) when patients incompletely respond to glucocorticoids. Their effectiveness is unproved in randomized controlled trials (RCTs). We evaluated their benefits in a placebo-controlled factorial RCT.
methodsA 56-week multicentre factorial-design double-blind placebo-controlled RCT compared steroids alone, MTX (15-25 mg weekly) plus steroids, ciclosporin (1-5 mg/kg/day) plus steroids and all three treatments. It enrolled adults with myositis (by Bohan and Peter criteria) with active disease receiving corticosteroids.
resultsA total of 359 patients were screened and 58 randomized. Of the latter, 37 patients completed 12 months of treatment, 7 were lost to follow-up and 14 discontinued treatment. Patients completing 12 months of treatment showed significant improvement (P < 0.001 on paired t-tests) in manual muscle testing (14% change), walking time (22% change) and function (9% change). Intention to treat and completer analyses indicated that ciclosporin monotherapy, MTX monotherapy and ciclosporin/MTX combination therapy showed no significant treatment effects in comparison with placebo.
conclusionNeither MTX nor ciclosporin (by themselves or in combination) improved clinical features in myositis patients who had incompletely responded to glucocorticoids.
trial registrationInternational Standard Randomized Controlled Trial Number Register; http://www.controlled-trials.com/; ISRCTN40085050.
Indexed as
Adrenal Cortex HormonesCyclosporineDouble-Blind MethodDrug Therapy, CombinationFemaleHumansImmunosuppressive AgentsMaleMethotrexateMyositisTreatment OutcomeAdrenal Cortex HormonesCyclosporineImmunosuppressive AgentsMethotrexatebasic and clinical sciencesclinical trials and methodsDMARDs therapiesimmunosuppressant therapiesmyositis and muscle diseasepsychology and social phenomenaquality of liferheumatic diseases
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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.