Anifrolumab is associated with reducing systemic lupus erythematosus (SLE) disease activity and enabling sustained glucocorticoid tapering, which was shown to have clinical benefits in these patients, according to study results published in Rheumatology.
Researchers conducted a post hoc analysis of the 52-week, randomized, placebo-controlled TULIP-1 and TULIP-2 trials (ClinicalTrials.gov Identifiers: (NCT02446912 and NCT02446899) of anifrolumab among patients with moderate to severe SLE. Participants were randomly assigned to anifrolumab 300 mg or placebo. During the 48-week treatment period, anifrolumab was administered intravenously once every 4 weeks in addition to standard therapy.
A total of 726 individuals were included in the TULIP trials, with 360 receiving anifrolumab and 366 receiving placebo. The majority of participants (82%; n=595) were receiving glucocorticoids at baseline, of whom 375 received doses of at least 10 mg per day (anifrolumab, n=190; placebo, n=185). For the group receiving at least 10 mg per day at baseline, the researchers examined changes in safety, participant-reported outcomes, and glucocorticoid dose. Participants with sustained tapering (defined by ≤7.5 mg daily by week 40, with this level sustained through week 52) were compared with nonresponders for outcome measures, as well as those receiving anifrolumab vs placebo.
Among the group receiving glucocorticoids of at least 10 mg per day at baseline, 41% (n=155/375) sustained tapering through week 52. Compared with the nonresponders (n=220), those with sustained tapering had mean glucocorticoid dose reductions of 32% (P <.001), reduced blood pressure, improved scores on participant-reported outcomes (P <.001), and fewer serious adverse events (SAEs). Anifrolumab vs placebo was associated with more patients with a sustained tapering response (51% vs 32%; P <.001), as well as reduced overall disease activity (38% vs 23%, respectively; P =.002).
Limitations to the study included the exclusion of pooled data from the general testing strategy, potential imbalances in baseline variables and stratification factors, an inability to demonstrate the clinical relevance of glucocorticoid-associated changes, the need for a longer trial, and a lack of data on other glucocorticoid-mediated effects.
Study authors concluded that “sustained glucocorticoid tapering was associated with several key benefits in patients with moderate to severe SLE, including improved health status, numerically fewer SAEs, and improvements in blood pressure control.” They indicated that this confirms “the importance of minimizing glucocorticoid use as a key treatment goal in SLE management.” The authors also noted that “anifrolumab treatment enabled sustained glucocorticoid tapering, while improving overall SLE disease activity.”
Disclosure: This clinical trial was supported by AstraZeneca. Please see the original reference for a full list of authors’ disclosures.
Bruce IN, van Vollenhoven RF, Morand EF, et al. Sustained glucocorticoid tapering in the phase 3 trials of anifrolumab: a post hoc analysis of the TULIP-1 and TULIP-2 trials. Rheumatology. Published online August 26, 2022. doi:10.1093/rheumatology/keac491