GlaxoSmithKline’s Benlysta reduced lupus patients’ need for higher doses of corticosteroids, a therapy that is beneficial but causes long-term organ damage, an additional analysis of Phase 3 clinical trial results shows.
In addition, a combination of Benlysta and corticosteroids reduced patients’ organ damage more than corticosteroids alone over five years, two extensions of the trial showed.
GlaxoSmithKline presented the findings in two poster sessions at the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting in San Diego, Nov. 3-8.
The Phase 3 BLISS-SC trial (NCT01484496) involved 836 adults with lupus stemming from autoantibodies who were on corticosteroids. Participants received either an injection of Benlysta or a placebo, plus a corticosteroid, once a week for 52 weeks.
GlaxoSmithKline published the results in the journal Arthritis & Rheumatology. The article was titled “Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty‐Two–Week Randomized, Double‐Blind, Placebo‐Controlled Study.”
The first poster session in San Diego covered additional findings of the trial. It was titled “The Effect of Subcutaneous Belimumab on Corticosteroid Use in Patients with Systemic Lupus Erythematosus (SLE): A Phase 3, Randomized, Placebo-Controlled Study.”
It reported that the percentage of patients who required a 50 percent increase in their corticosteroid dose during the 52-week treatment period was lower in the Benlysta arm than in the placebo arm — 4.9 percent versus 7.9 percent. Another finding was that the percentage of patients able to cut their corticosteroid dose by 50 percent or more during the 52 weeks was similar between the Benlysta and placebo groups, however.
At the start of the trial, 60 percent of participants were receiving a corticosteroid dose higher than 7.5 mg per day. By the end, 18 percent of the Benlysta patients had been able to cut their corticosteroid use by a quarter, compared with 12 percent in the placebo group. The difference wasn’t statistically significant, though.
The other poster session reported that patients who took a combination of Benlysta and corticosteroids had significantly less organ damage over five years than those who received cortcosteroids alone. The session was titled “A Propensity Score-Matched Study of Organ Damage in Patients with Systemic Lupus Erythematosus from the BLISS Long-Term Extension Trials Versus the Toronto Lupus Cohort: A Post Hoc Longitudinal Analysis.”
Researchers based their report on the combined results of the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) extension studies. Patients in BLISS-52 were treated for 52 weeks and in BLISS-76 for 76 weeks.
Benlysta’s benefits started the first year and continued, researchers said.
Patients who received Benlysta were 61 percent less likely to experience additional organ damage. And if additional damage did occur, the rate at which it happened was lower than in the non-Benlysta group.
“These findings support results from a previous analysis of the BLISS long-term extension studies, published last year,” Dr. Murray Urowitz, a medical professor at the University of Toronto, said in a press release. “The results are encouraging, and indicate the potential impact of belimumab on organ damage progression in patients living with this chronic condition,” said Urowitz, the lead author of the study.
Autoimmune diseases such as lupus involve the immune system attacking healthy tissue rather than invaders. Immune B-cells are associated with the development of autoimmune diseases such as lupus.
Benlysta blocks the B-lymphocyte stimulator, a protein crucial to the survival of immune B-cells. This means that blocking the stimulator decreases the production of autoantibodies.
At the moment, Benlysta is the only medicine approved for lupus. TheU.S. Food and Drug Administration, the European Medicines Agency and Japanese regulators have authorized it for the treatment of adults whose lupus stems from autoantibodies.
Benlysta’s effectiveness has yet to be tested in patients with severe active lupus nephritis or severe active central nervous system lupus.
”Reducing reliance on corticosteroids to treat symptoms of SLE [lupus] is a key treatment goal for patients and physicians,” Dr. April Thompson, the scientific director of Global Immunology, said in a press release.”The findings reported here suggest that Benlysta added to standard of care may prove beneficial by reducing the need for an increase in corticosteroid dose.”