Study participants were randomized into two groups. Group 1 received 1,000 mg of intravenous (IV) obinutuzumab at baseline and weeks 2, 24, 26, 50 and 52, along with mycophenolate mofetil (MMF) and oral prednisone. The MMF was administered to a target dose of 2.0–2.5 g/day in divided doses through week 80. The prednisone dose was 0.5 mg/kg/day (maximum 60 mg/day), which started on day 2 of the study. On day 15, the prednisone dose was tapered to 5 mg/day and continued through week 80.
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 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.
Other ongoing investigations with obinutuzumab include use in children and adolescents with lupus nephritis, as well as in individuals with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and SLE.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- UCB and Biogen announce positive topline results from phase 3 study of dapirolizumab pegol in systemic lupus erythematosus and are initiating second phase 3 study in 2024 [news release]. Biogen. 2024 Sep 24.
- A study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus (PHOENYCS GO) [NCT04294667]. ClinicalTrials.gov. 5 Jul 2024.
- Biologics license application approval letter for Gazyva (obinutuzumab). U.S. Food & Drug Administration. 2013 Nov 1.
- Highlights of prescribing information: Gazyva (obinutuzumab). U.S. Food & Drug Administration. 2022 Jul 27.
- 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.
- Dennis M. Roche’s Gazyva hoping for second wind after lupus study success. FirstWordPharma.org. 2024 Sep 27.
