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Trials Find Potential Treatments for SLE, Lupus Nephritis

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Group 2 received 1,000 mg of IV obinutuzumab at baseline and weeks 2, 24, 26 and 52, plus MMF and oral prednisone. Group 2 participants received a placebo infusion starting at their week 50 visit. All patients were premedicated against infusion reactions with 650–1,000 mg of acetaminophen, 80 mg of IV methylprednisolone and 50 mg of diphenhydramine.

The results: A higher proportion of patients treated with obinutuzumab plus standard therapy achieved a complete renal response (CRR) at week 76 than patients who received only standard therapy (i.e., group 2). These results were both clinically and statistically significant (P value not reported).6 Key secondary end points were also met, including the proportion of people achieving CRR with a reduced corticosteroid use and a reduced urine protein response. No new safety signals were identified.

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On March 5, the FDA accepted the supplemental Biologics License Application for obinutuzumab (Gazyva) for treatment of lupus nephritis.5 The acceptance is based on positive results from the REGENCY study. The FDA is expected to make an approval decision by October 2025.

Ongoing investigations include the use of obinutuzumab in children and adolescents with lupus nephritis, as well as in individuals with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and SLE.

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Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

  1. Biologics license application approval letter for Gazyva (obinutuzumab). U.S. Food & Drug Administration. 2013 Nov 1.
  2. Highlights of prescribing information: Gazyva (obinutuzumab). U.S. Food & Drug Administration. 2022 Jul 27.
  3. A study to evaluate the efficacy and safety of obinutuzumab in patients with ISN/RPS 2003 class III or IV lupus nephritis (REGENCY) [NCT04221477]. ClinicalTrials.org. 2024 Jul 17.
  4. Dennis M. Roche’s Gazyva hoping for second wind after lupus study success. FirstWordPharma.org. 2024 Sep 27.
  5. FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis [news release]. Roche. 2025 Mar 4. https://www.roche.com/media/releases/med-cor-2025-03-05.
  6. Dennis M. Roche’s Gazyva hoping for second wind after lupus study success. FirstWordPharma.org. 2024 Sep 27.

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