Anifrolumab exhibited a high retention rate, effectively improved disease activity, and reduced glucocorticoid (GC) doses among patients with systemic lupus erythematosus (SLE), including those who experienced minor flares after achieving low disease activity, according study results published in Rheumatology.

Standard treatment for SLE involves GCs and immunosuppressants, with the end goal of achieving a Lupus Low Disease Activity State (LLDAS). Despite current advances, treatments often lead to drug-induced organ damage, greatly affecting quality of life. Researchers examined anifrolumab, a new therapeutic agent targeting the interferon pathway, for its utility in SLE maintenance therapy, specifically among patients who have failed to achieve LLDAS or experienced flares after LLDAS achievement.

A retrospective observational study was conducted, including patients in Japan with SLE who initiated anifrolumab therapy after November 2021. Patients were categorized based on LLDAS criteria: those who failed to achieve LLDAS (non-LLDAS achievement group), those who experienced minor flares despite achieving LLDAS (minor flare group), and those aiming for remission with GC dose reduction (GC dose reduction group).

Safety was investigated up to week 26 and efficacy was evaluated up to week 12, following intravenous infusions of 300 mg anifrolumab every 4 weeks. Additionally, anifrolumab safety and efficacy were compared to a standard of care (SoC) group (patients who achieved LLDAS with minor flares who did not initiate anifrolumab).

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The primary study endpoint was anifrolumab retention rate at 26 weeks postinitiation.

Overall, 45 patients were included in the study, including 14 who failed to achieve LLDAS, 27 patients who experienced minor flares, and 4 who were treated for remission and GC reduction. The mean patient age was 45 years, with hydroxychloroquine used in a majority (85%) of patients. At baseline, organ damage was observed primarily in the joints (arthritis), skin (mucocutaneous lesions), and marrow (cytopenia).

The 26-week retention rates following initiation of anifrolumab therapy were analyzed in 39 patients, with an overall rate of 89.7% (35/39 patients). Reasons for discontinuation included inadequate response (3 patients) and allergic reactions (1 patient).

Retention rates varied among the groups, corresponding to 90.9% (10/11 patients) in the non-LLDAS achievement group, 91.7% (22/24 patients) in the minor flare group, and 75% (3/4 patients) in the GC dose reduction group.

Adverse events of Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher were observed among 23.1% (9/39) of patients up to week 26; these  primarily consisted of infections (8 patients, including 5 with coronavirus). All infected patients who had received vaccinations experienced mild symptoms that improved with antiviral agents. Notably, no interruptions or discontinuations of anifrolumab treatment occurred due to infections.

No serious adverse events of CTCAE grade 3 or higher were reported. Additionally, adverse events up to week 12 were documented in 13.3% (6/45 patients) of total patients.

In the non-LLDAS achievement group, the rate of LLDAS at week 12 was 42.9%, compared with 66.7% in the minor flare group. Additionally, GC doses were significantly decreased at 8 and 12 weeks among both groups.

Overall, 7.4% of patients in the minor flare group experienced flares (skin rash), while no patients in the non-LLDAS achievement group did.

Following adjustment for propensity scores with inverse probability treatment weighting, no significant differences between the anifroluamb group and the SoC group were found in terms of LLDAS achievement or Definition of Remission in Systemic Lupus Erythematosus rates at week 12.

Both groups exhibited improvements in Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index scores, with a significant decrease in oral GC doses seen in the anifrolumab group. There were no significant differences in adverse events between the groups.

Study limitations included the small sample size and lack of data on anifrolumab’s ability to prevent other types of organ damage.

Study authors concluded, “These findings suggested that disease activity could be improved by initiating anifrolumab therapy alone without GC dose increase in patients with minor flares.”

Disclosure: One or more of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Miyazaki Y, Funada M, Nakayamada S, et al. Safety and efficacy of anifrolumab therapy in systemic lupus erythematosus in real-world clinical practice: LOOPS registry. Rheumatol. Published online November 2, 2023. doi:10.1093/rheumatology/kead568

This article originally appeared on Rheumatology Advisor

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