Abstract | OBJECTIVE: METHODS: This was a placebo-controlled (week 24), phase II study in 102 patients with seropositive active SLE. Patients were randomized to ustekinumab (approximately 6 mg/kg single intravenous infusion, then subcutaneous [SC] injections of 90 mg every 8 weeks) or placebo, added to background therapy. Placebo patients initiated ustekinumab (90 mg SC every 8 weeks) at week 24. Patients could enter an optional open-label study extension after week 40 (final ustekinumab administration at week 104). Efficacy assessments included Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), SLEDAI-2K Responder Index-4 (SRI-4), physician global assessment ( PGA), and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI). Observed data are reported for the extension period. The final efficacy assessment was at week 112; safety was monitored through week 120. RESULTS: In this subset of patients who entered the study extension, 24 in the ustekinumab group and 14 in the placebo crossover group completed study treatment. At week 112, 79% and 92%, respectively, had an SRI-4 response; 92% in both groups had ≥ 4-point improvement from baseline in SLEDAI-2K score; 79% and 93%, respectively, had ≥ 30% improvement from baseline in PGA; 86% and 91%, respectively, had ≥ 50% improvement in active joint (pain and inflammation) count; and 79% and 100%, respectively, had ≥ 50% improvement in CLASI Activity Score. No deaths, malignancies, opportunistic infections, or tuberculosis cases occurred. Safety events were consistent with the known ustekinumab safety profile. CONCLUSION: Of the 46 patients who entered the voluntary extension of this phase II study, clinical benefit in global and organ-specific SLE activity measures was observed with ustekinumab through 2 years with no new or unexpected safety findings. [ClinicalTrials.gov: NCT02349061].
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Authors | Ronald F van Vollenhoven, Bevra H Hahn, George C Tsokos, Peter Lipsky, Robert M Gordon, Kaiyin Fei, Kim Hung Lo, Marc Chevrier, Shawn Rose, Pamela Berry, Zhenling Yao, Chetan S Karyekar, Qing Zuraw |
Journal | The Journal of rheumatology
(J Rheumatol)
Vol. 49
Issue 4
Pg. 380-387
(04 2022)
ISSN: 0315-162X [Print] Canada |
PMID | 34853089
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2022 by the Journal of Rheumatology. |
Chemical References |
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Topics |
- Double-Blind Method
- Humans
- Injections, Subcutaneous
- Lupus Erythematosus, Systemic
(drug therapy)
- Severity of Illness Index
- Treatment Outcome
- Ustekinumab
(adverse effects)
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