Summary
Adalimumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Systemic Lupus Erythematosus (SLE) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Systemic Lupus Erythematosus (SLE). ClinicalTrials.gov lists 1 registered trial linking Adalimumab to Systemic Lupus Erythematosus (SLE): 1 is active or not yet recruiting. The most advanced is Phase 2 (NCT07138898). It plans or enrolled 80 participants. Registered activity dates to 2025. The literature layer holds 5 publications for this pair: 1 Cochrane review, 3 systematic reviews and 1 clinical trial publication. Publication years run from 2007 to 2025. 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 Systemic Lupus Erythematosus ranks 276 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 drug-free remission: 2-10% in some cohorts over 5 years; disease-free survival in 15-20% at 20 years; renal lupus (LN) progression to ESRD in 10-20% within 20 years on standard care.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 39.0 (trials 3.0, literature 16.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 1 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 5 (3 systematic reviews, 1 Cochrane review, 1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | ATG5 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT07138898 | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty 2025 | not yet recruiting | Phase 2 | 80 |
Published literature
- Systematic review A systematic review of the efficacy of TYK2 inhibitors in patients with dermatological diseaseHaggett MG, Lee S, Lai FYX · The Australasian journal of dermatology · 2025 · PMID 39641243
- Systematic review Biologic disease modifying antirheumatic drugs and Janus kinase inhibitors in paediatric rheumatology - what we know and what we do not know from randomized controlled trialsWelzel T, Winskill C, Zhang N et al. · Pediatric rheumatology online journal · 2021 · PMID 33766063
- Cochrane review Epidemiological and advanced therapeutic approaches to treatment of uveitis in pediatric rheumatic diseases: a systematic review and meta-analysisJari M, Shiari R, Salehpour O et al. · Orphanet journal of rare diseases · 2020 · PMID 32019589
- Systematic review A systematic review of the off-label use of biological therapies in systemic autoimmune diseasesRamos-Casals M, Brito-Zerón P, Muñoz S et al. · Medicine · 2008 · PMID 19011506
- Clinical trial publication Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: the Research in Active Rheumatoid Arthritis (ReAct) trialBurmester GR, Mariette X, Montecucco C et al. · Annals of the rheumatic diseases · 2007 · PMID 17329305
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 ATG5. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Adalimumab approved for Systemic Lupus Erythematosus (SLE)?
Adalimumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Systemic Lupus Erythematosus (SLE) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Systemic Lupus Erythematosus (SLE). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Adalimumab in clinical trials for Systemic Lupus Erythematosus (SLE)?
ClinicalTrials.gov lists 1 registered trial linking Adalimumab to Systemic Lupus Erythematosus (SLE): 1 is active or not yet recruiting. The most advanced is Phase 2 (NCT07138898). It plans or enrolled 80 participants. Registered activity dates to 2025.
What does the evidence show for Adalimumab in Systemic Lupus Erythematosus (SLE)?
Trials of Adalimumab in Systemic Lupus Erythematosus (SLE) are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. 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 ATG5. 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 2026-07-05. Page built 2026-10-07.