Trial reportRMD open2025
Efficacy and safety of upadacitinib as monotherapy or combined with elsubrutinib for the treatment of systemic lupus erythematosus: results through 104 weeks in a long-term extension study.
Trial report in RMD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.
What it found
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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.
A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)
Who cites it
6 citing papers in PubMed.
- Advances in the treatment of systemic lupus erythematosus: Biologicals, small-molecular agents, and cell-depleting therapies coming to the clinic.Journal of internal medicine · 2026Review
- Upadacitinib enhances platelet procoagulant responses in a subset of healthy individuals and patients with SLE: a pilot study.Lupus science & medicine · 2026Article
- Potential of chimeric antigen receptor (CAR) T cell immunotherapy in systemic lupus erythematosus (SLE).Clinical rheumatology · 2026Review
- Targeting STAT3 in systemic lupus erythematosus and lupus nephritis: mechanisms, therapeutic advances, and structure-informed perspectives.Frontiers in pharmacology · 2026Review
- The Type I Interferon Axis in Systemic Autoimmune Diseases: From Molecular Pathways to Targeted Therapy.Biomolecules · 2025Review
- Signaling pathways in systemic lupus erythematosus and therapeutic implications.Frontiers in immunology · 2025Review
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThis 1-year long-term extension (LTE) study (NCT04451772) followed the 48-week phase 2 SLEek study (NCT03978520) that evaluated upadacitinib (a Janus kinase inhibitor) alone or combined with elsubrutinib (a Bruton's tyrosine kinase inhibitor) in adults with moderately to severely active systemic lupus erythematosus (SLE). The objective was to evaluate the efficacy and safety of an additional 56 weeks of treatment.
methodsPatients randomised to upadacitinib 30 mg one time per day (QD) or upadacitinib 30 mg/elsubrutinib 60 mg QD (upadacitinib/elsubrutinib) in the SLEek study continued their assigned treatment during the LTE. Patients originally receiving placebo switched to upadacitinib/elsubrutinib in the LTE. Assessments through week 104 included SLE Responder Index-4 (SRI-4), British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA), Lupus Low Disease Activity State (LLDAS), change from baseline in glucocorticoid dose, flare events and adverse events.
resultsThis LTE analysis included 127 patients. Efficacy responses for the groups receiving upadacitinib, upadacitinib/elsubrutinib and placebo to upadacitinib/elsubrutinib were maintained or increased from weeks 48 to 104 (week 104: SRI-4: 82.1%, 85.4% and 61.3%; BICLA: 69.2%, 78.0% and 54.8%; LLDAS: 60.0%, 78.0% and 34.4%). From weeks 48 through 104, the mean daily glucocorticoid dose was reduced, and the incidence of flares was maintained or further reduced in all treatment groups. Safety profiles were similar to those observed in the primary SLEek study.
conclusionsIn this LTE study, upadacitinib monotherapy and upadacitinib/elsubrutinib combined were well tolerated and continued to demonstrate beneficial effects on SLE disease activity, glucocorticoid dose and flares through 104 weeks.
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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 Socratic graph.