Adding anifrolumab superior to standard therapy alone, maintains remission in lupus
Key takeaways:
- Patients on anifrolumab spent more time in remission and low disease activity, and reached those states more quickly, vs. placebo.
- Achieving these states can stave off permanent organ damage.
Adding anifrolumab to standard treatment for systemic lupus erythematosus led to faster achievement of low disease activity and remission, and more time spent in those states, vs. standard therapy alone, according to data.
“The results reported here are based on the phase 3 clinical trial program for anifrolumab, the interferon type 1 receptor-binding monoclonal antibody that has been approved for the treatment of lupus,” Ronald van Vollenhoven, MD, PhD, chair of the department of rheumatology and clinical immunology at the Amsterdam Medical Center, and director of the Amsterdam Rheumatology Center, told Healio.
“In those trials, nicknamed TULIP 1 and 2, and in the continuation trial where patients were kept on the same treatment for an additional 3 years, many of the standard clinical outcomes supported the efficacy of anifrolumab over placebo,” he added. “To what extent patients achieved low disease activity or remission was not previously studied in detail and was done here.”
To examine the long-term rates of low disease activity and remission among patients with SLE receiving anifrolumab (Saphnelo, AstraZeneca), vs. placebo, van Vollenhoven and colleagues conducted a post-hoc analysis of data from TULIP 1 and TULIP 2, as well as their extension trial. The researchers included 369 patients with SLE who, in the original TULIP trials, were randomly assigned to receive either 300 mg of anifrolumab intravenously or placebo every 4 weeks in addition to standard therapy. These patients then continued with the same treatment in the 3-year extension.
At the end of the 3-year extension, 36.9% of patients on anifrolumab met LLDAS criteria compared with 17.1% of those on placebo (OR = 2.7; 95% CI, 1.3-5.5), according to the researchers. The DORIS remission rate was also higher among anifrolumab-treated patients, at 30.3% vs. 18.3% with placebo (OR = 1.9; 95% CI, 1-3.9).
Cumulatively, patients who received anifrolumab spent more time in LLDAS (nominal P = .0004) and DORIS remission (nominal P = .0032) compared with placebo. In addition, patients using anifrolumab also demonstrated a faster time to their first attainment of both LLDAS and DORIS. Specifically, half the anifrolumab group acheived LLDAS by 9.9 months vs. 20.2 months in the placebo group. Meanwhile, a quarter of the anifrolumab group achieved DORIS remission by 14.8 months, compared with 20.6 months among those in the placebo group. Less than half of the placebo group ever reached DORIS remission.
“Both LLDAS and DORIS were achieved more frequently with anifrolumab than with placebo, and the difference was statistically significant in most cases,” van Vollenhoven said. “Thus, the efficacy of the medication was supported. However, it was also noted that the absolute number of patients who achieved these important therapeutic goals was not very high.”
At the end of the study, 58 of 194 patients who received anifrolumab were in DORIS remission, while 67 were in LLDAS.
“Perhaps some would have expected even better results for low disease activity and remission, but the reality of treating lupus in this refractory group is that there still remains a considerable unmet need,” van Vollenhoven added. “For the longer-term future, perhaps combining novel therapies will bring additional hope for patients with lupus.”
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