Avoiding organ damage in lupus care
BY SARA FREEMAN
In a post hoc analysis of patients with systemic lupus erythematosus (SLE) who were treated with belimumab (Benlysta) and matched to patients treated with the standard of care, damage scores at 5 years were a respective 0.265 and 0.718, a difference of –0.453 fewer units that favored the use of belimumab therapy (P less than .001).
There also were slower annual rates of organ damage progression (3.1% vs. 7.5%), as measured by the time to first increase in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI).
In fact, “patients treated with belimumab were 60% less likely [P less than .001] to progress to a higher SDI score over any given year of follow-up compared to patients treated with the standard of care alone,” said Murray B. Urowitz, MD.
These data make an argument that belimumab could be given for longer periods of time, David Isenberg, MD, of University College London Hospital, said in an interview at the EULAR 2018 Congress (see video).
Dr. Urowitz and his associates used pooled data from two long-term extension (LTE) studies of two phase 3 belimumab clinical trials and data from the Toronto Lupus Cohort (TLC). A total of 181 patients from the BLISS LTE studies were matched, using propensity scoring, to 181 patients in the TLC to assess the primary outcome of organ damage progression at 5 years, and 323 patients in the BLISS LTE studies were matched to 323 in the TLC to look at the rate of organ damage progression over 1 year or more, and the year-on-year magnitude of change in organ damage over 5 years or more (Arthritis Rheum. 2018;77:177. Abstract OP0254).
In a separate presentation at the Congress, Ronald F. van Vollenhoven, MD, also reported on organ damage progression and the long-term safety of belimumab in a long-term extension in non-U.S. patients involving almost 700 patients.
“Organ damage accrual is, and remains, very limited,” said Dr. van Vollenhoven, professor of rheumatology at the University of Amsterdam. The majority of patients experienced no change in SDI scores from baseline (94.3%) to week 48 (87.7%) of each year of follow up out to 8 years, he said.
Importantly, “belimumab displayed a stable safety profile over 8 years of exposure and no new safety signals were observed,” Dr. van Vollenhoven said. He highlighted that the incidence of adverse events, serious adverse events, and adverse events leading to discontinuation were broadly similar to previous studies.
“We were specifically pleased to see no increase, and in fact a decrease, in psychiatric events as it had been raised as a concern, but it does not seem to pan out over time,” Dr. van Vollenhoven said. Overall, 11.7% of patients had depression, suicidal thoughts or self-harmed over the follow-up period, with the rate falling from 10.5% at baseline to 1.8% by year 6-7 (Arthritis Rheum. 2018;77:175. Abstract OP0252).
The belimumab studies were supported by GlaxoSmithKline. Dr. Urowitz disclosed receiving grant or research support from GSK as well as acting as a consultant to the company. Dr. Isenberg had no relevant financial conflicts of interest to disclose. Dr. van Vollenhoven disclosed receiving research support and grants from a variety of pharmaceutical companies including GSK and being the editor in chief of the journal Lupus Science & Medicine.
Sara Freeman is a freelance reporter with MDedge News.