In a significant development for lupus treatment, two promising B-cell depleting therapies, obinutuzumab and ianalumab, are showing potential in clinical trials. This information was shared during the 2024 Congress of Clinical Rheumatology held in San Diego, where Dr. Richard A. Furie, chief of the rheumatology division at Northwell Health, expressed optimism about the future of lupus therapies.
Dr. Furie emphasized that the ongoing research and trials indicate a forthcoming approval of new drugs, which could lead to improved outcomes for patients suffering from lupus. He stated, “I am optimistic about the future,” highlighting the advancements being made in the field.
Obinutuzumab, marketed as Gazyva by Genentech, is an anti-CD20 antibody that has been engineered to enhance its potency compared to its predecessor, rituximab (Rituxan). Dr. Furie explained that obinutuzumab has been glycoengineered to achieve approximately 100-fold greater antibody-dependent cytotoxicity, leading to more effective B-cell elimination. In the phase 2 trial named NOBILITY, which focused on lupus nephritis, the results demonstrated a significant level of B-cell depletion and a higher complete renal response rate compared to a placebo group.
According to Dr. Furie, at the one-year mark, the effect size was around 12 percentage points, which increased to nearly 20 percentage points at the one-and-a-half-year mark and was maintained at close to 20% after two years. Patients in the trial received re-treatment at six months, showing a durable response lasting up to 1.5 years post-treatment.
Recently, it was announced that the phase 3 study for obinutuzumab in lupus nephritis, known as REGENCY, yielded positive results, indicating a significant step forward in the treatment landscape for lupus.
In addition to obinutuzumab, Dr. Furie discussed ianalumab, developed by Novartis, which operates through a dual mechanism. This therapy not only depletes B cells but also inhibits the B-cell activating factor (BAFF) pathway, also referred to as the B lymphocyte stimulator (BLyS) pathway. Ianalumab first demonstrated its efficacy in a Sjögren’s syndrome trial, showing profound B-cell depletion.
Moreover, in a small phase 2 study focused on systemic lupus erythematosus (SLE), ianalumab exhibited significant B-cell depletion and a notable effect on the SLE Responder Index 4 response, according to Dr. Furie. Currently, ianalumab is undergoing additional studies in both SLE and lupus nephritis trials.
The advancements in these therapies could mark a new era in the management of lupus, a chronic autoimmune disease that affects millions worldwide. As research continues, the medical community remains hopeful for more effective treatments that can enhance the quality of life for lupus patients.
The 2024 Congress of Clinical Rheumatology serves as a vital platform for sharing groundbreaking research and clinical findings, highlighting the ongoing commitment to improving patient care in rheumatology. With the promising data surrounding obinutuzumab and ianalumab, the future of lupus treatment appears to be on a positive trajectory.