Subcutaneous administration of anifrolumab a potential option for SLE
- 09-01-2026
- Systemic Lupus Erythematosus
- Editor's Choice
- News
medwireNews: Weekly subcutaneous anifrolumab has shown treatment benefits for patients with systemic lupus erythematosus (SLE) consistent with those seen with the monthly intravenous form of the type 1 interferon receptor antibody.
“When clinical effectiveness is similar, the choice of administration route is an important part of shared decision-making that takes into account multiple factors, such as the impact of treatment choice on daily activities, treatment adherence, insurance mandates, and local healthcare delivery,” say Catharina Lindholm (AstraZeneca, Gothenburg, Sweden) and colleagues.
They believe that for anifrolumab, “the [subcutaneous] route of administration will provide an important alternative route of at-home administration and may increase treatment accessibility for patients with moderate to severe SLE.”
The team adds that “reducing the number of infusion visits may also reduce the cost and time burden of SLE patients and to health systems.”
The phase 3 trial – TULIP-SC – involved 367 patients who had moderate-to-severe active SLE despite taking standard therapy and were randomly assigned to receive subcutaneous anifrolumab 120 mg (n=184) or placebo (n=183) once weekly for 52 weeks. The patients had a mean age of 42.5 years, and the majority (92%) were women.
Patients receiving glucocorticoid doses of at least 10.0 mg/day attempted tapering to 7.5 mg/day or lower from weeks 8 to 40, after which doses were required to be stable until the end of treatment.
The primary endpoint was met at the interim analysis of the first 220 patients to complete 52 weeks of treatment, with a significant 15.5% more patients treated with anifrolumab than placebo achieving a British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response, at rates of 59.4% versus 43.9%.
This meant that they achieved the following criteria: a reduction from baseline in all organ systems from BILAG-2004 A to B/C/D, or B to C/D; no worsening in the SLE Disease Activity Index 2000 (SLEDAI-2K) from baseline; and less than a 0.3-point increase from baseline on the 3-point Physician Assessment Global Visual Analog Scale (PGA VAS).
Consistent findings were seen in the full analysis at 52 weeks, with 56.2% of patients treated with anifrolumab having a BICLA response, which was significantly more than the 37.1% of patients given placebo.
“BICLA response rates were consistently significantly higher in the anifrolumab group than the placebo group from Week 24 and onwards, with separation observed from Week 16,” note the researchers in Arthritis & Rheumatology.
A significant treatment difference was also seen at week 52 for Definitions of Remission In SLE (DORIS) and Lupus Low Disease Activity State (LLDAS). DORIS remission was based on patients having a score of 0 points on all SLEDAI items, except for increased DNA binding and low complement scores; a PGA VAS score below 0.5 points; and a prednisone or equivalent dose of 5 mg/day or less, and stable doses of immunosuppressants. It was achieved by 29.0% of anifrolumab-treated patients, compared with 14.7% of placebo-treated patients.
LLDAS was achieved at week 52 by 40.1% of patients in the anifrolumab group versus 26.0% of those in the placebo group, and required patients to have a SLEDAI-2K score of 4 points or below, no new SLEDAI-2K disease activity compared with the previous assessment, a PGA VAS score below 1 point, and be taking a prednisone or equivalent dose of no more than 7.5 mg/day and standard maintenance doses of immunosuppressants.
“Taken together, these findings suggest that weekly [subcutaneous] anifrolumab has comparable efficacy and safety to the approved [intravenous] route of administration,” say the investigators.
With regard to safety, “the frequency of overall AEs [adverse events] balanced between treatment groups,” they report, with rates of any AE of 85.9% and 78.6% in the anifrolumab and placebo groups, respectively.
The exception was higher rates of upper respiratory tract infection and diarrhea with anifrolumab than placebo, at 10.3% versus 5.5%, and 5.4% versus 0.5%, respectively.
“As expected, the rate of herpes zoster was greater with anifrolumab (3.8%) than with placebo (1.1%),” observe Lindholm et al, but there were no opportunistic infections and serious AEs “were of low frequency.”
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