A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
Summary
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.
Timeline
- Start
- 2018-04-16
- Primary completion
- 2020-11-05
- Completion
- 2020-11-05
Outcome
Missed primary endpoint
Stopped: “Study terminated early as a result of the outcome of the pre-planned Interim Analysis”
paper At week 52, 44% of ustekinumab patients and 56% of placebo patients had an SRI-4 response PMID 35798534 ↗
paper Ustekinumab did not demonstrate superiority over placebo in this population of adults with active SLE PMID 35798534 ↗
release “decision to discontinue the Phase 3 LOTUS study of STELARA®(ustekinumab) in Systemic Lupus Erythematosus (SLE) due to lack of efficacy in SLE.” jnj.com ↗
Publications
- van Vollenhoven RF, Kalunian KC, Dorner T, Hahn BH, Tanaka Y, Gordon RM, Shu C, Fei K, Gao S, Seridi L, Gallagher P, Lo KH, Berry P, Zuraw QC. Phase 3, multicentre, randomised, placebo-controlled study evaluating the efficacy and safety of ustekinumab in patients with systemic lupus erythematosus. Ann Rheum Dis. 2022 Oct 12;81(11):1556-1563. doi: 10.1136/ard-2022-222858.
- Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ustekinumab | Monoclonal antibody | 90 mg | Intravenous |