Summary
Methylprednisolone has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Myopathies (Dermatomyositis / PM / IBM) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Myopathies (Dermatomyositis / PM / IBM). ClinicalTrials.gov lists 5 registered trials linking Methylprednisolone to Inflammatory Myopathies (Dermatomyositis / PM / IBM): 5 have completed. The most advanced is Phase 3 (NCT00323960). It plans or enrolled 139 participants. Registration activity spans 1997 to 2014. The literature layer holds 7 publications for this pair: 1 Cochrane review, 1 systematic review and 5 clinical trial publications. Publication years run from 1999 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Dermatomyositis ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous remission in ~10-15% over 2 years without treatment; IBM (inclusion body myositis) is slowly progressive with no effective treatment; death from interstitial lung disease in dermatomyositis in 5-10%.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 55.5 (trials 17.5, literature 18.0, tier 15, approved bonus 5.0) |
| Registered trials | 5 total: 0 recruiting, 0 active / not yet recruiting, 5 completed, 0 other |
| Linked publications | 7 (5 clinical trial publications, 1 Cochrane review, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | CD80 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00323960 | Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis 2006 | completed | Phase 3 | 139 |
| NCT00651040 | Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM 2008 | completed | Phase 3 | 31 |
| NCT00004357 | Absorption of Corticosteroids in Children With Juvenile Dermatomyositis 1997 | completed | Phase 2 | 6 |
| NCT05509140 | Clinical Analysis of Juvenile Dermatomyositis Patients 2014 | completed | Not applicable | 12 |
| NCT00504348 | Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus 2007 | completed | PHASE2, PHASE3 | 25 |
Published literature
- Cochrane review Prevalence and clinical correlates of infection in idiopathic inflammatory myopathies: A systematic review and meta-analysis of 14,548 patientsYuan G, Xie X, Tang M et al. · Autoimmunity reviews · 2026 · PMID 42208667
- Systematic review Macrophage activation syndrome in juvenile dermatomyositis: a systematic reviewPoddighe D, Dauyey K · Rheumatology international · 2020 · PMID 31529231
- Clinical trial publication The PRINTO evidence-based proposal for glucocorticoids tapering/discontinuation in new onset juvenile dermatomyositis patientsGiancane G, Lavarello C, Pistorio A et al. · Pediatric rheumatology online journal · 2019 · PMID 31118099
- Clinical trial publication Clinical outcome following B cell depletion therapy in eight patients with refractory idiopathic inflammatory myopathySultan SM, Ng KP, Edwards JC et al. · Clinical and experimental rheumatology · 2008 · PMID 19032824
- Clinical trial publication Pharmacokinetic study of oral prednisolone compared with intravenous methylprednisolone in patients with juvenile dermatomyositisRouster-Stevens KA, Gursahaney A, Ngai KL et al. · Arthritis and rheumatism · 2008 · PMID 18240180
- Clinical trial publication Efficacy of early treatment of severe juvenile dermatomyositis with intravenous methylprednisolone and methotrexateAl-Mayouf S, Al-Mazyed A, Bahabri S · Clinical rheumatology · 2000 · PMID 10791626
- Clinical trial publication The effect of methylprednisolone pulse therapy in polymyositis/dermatomyositisBolosiu HD, Man L, Rednic S · Advances in experimental medicine and biology · 1999 · PMID 10599369
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CD80. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Methylprednisolone approved for Inflammatory Myopathies (Dermatomyositis / PM / IBM)?
Methylprednisolone has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Myopathies (Dermatomyositis / PM / IBM) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Myopathies (Dermatomyositis / PM / IBM). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Methylprednisolone in clinical trials for Inflammatory Myopathies (Dermatomyositis / PM / IBM)?
ClinicalTrials.gov lists 5 registered trials linking Methylprednisolone to Inflammatory Myopathies (Dermatomyositis / PM / IBM): 5 have completed. The most advanced is Phase 3 (NCT00323960). It plans or enrolled 139 participants. Registration activity spans 1997 to 2014.
What does the evidence show for Methylprednisolone in Inflammatory Myopathies (Dermatomyositis / PM / IBM)?
Methylprednisolone has both completed registered trials and synthesis-level publications linked to Inflammatory Myopathies (Dermatomyositis / PM / IBM). That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CD80. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.