Anifrolumab May Improve Refractory CLE in Systemic Lupus Erythematosus

Anifrolumab may be effective for patients with systemic lupus erythematosus (SLE) and refractory cutaneous lupus erythematosus (CLE), according to study findings published in Journal of the American Academy of Dermatology.

Researchers conducted a national multicenter, prospective study of patients with SLE and biopsy-proven active CLE who experienced treatment failure with at least 3 currently available CLE treatments, including belimumab. All participants were fully vaccinated against COVID-19 before receiving anifrolumab.

Intravenous anifrolumab 300 mg was administered every 4 weeks from August 2021 to May 2022, and follow-up lasted for at least 16 weeks.

The primary outcome was the proportion of patients who had a partial response (PR) at week 16, which was defined by a decrease of CLE Disease Area and Severity Index activity of at least 50% (CLASI-A 50). The researchers also evaluated adverse events and SLE activity using the Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index [SELENA-SLEDAI] score.

A total of 11 women were included (median age, 35 [range, 19-50] years) in the study. The median number of systemic treatment lines for CLE before receiving anifrolumab was 6 (3-9) per participant. At week 16, CLASI-A 50 was achieved by the 11 participants. Their median CLASI activity decreased from 15 (4-35) at baseline to 4 (0-19) at week 4 (P =.001) and 2 (0-13) at week 16 (P <.001). The median time to achieve CLASI-A 50 was 1 month (95% CI, 1.00-3.00).

Among the cohort, 7 participants received additional infusions after week 16, and 1 participant received them up to week 40. All of the women had sustained improvement in CLASI activity, with 6 participants (54%) having a complete response (CLASI-A=0). No significant variation was found for the median CLASI damage.

Participants’ median SELENA-SLEDAI score significantly decreased from 8 (4-22) at baseline to 4 (0-10) at week 16 (P = .002), and the 5 patients who had baseline articular involvement had their clinical symptoms disappear. The median prednisone dose was reduced from 10 mg/day (0-15) to 5 mg/day (0-10).

Adverse events (AEs) occurred in 8 (73%) participants, with a total of 10 AEs. No patient discontinued anifrolumab permanently owing to an AE. Infectious AEs included 2 cases of nonsevere COVID-19 with spontaneous recovery during which anifrolumab infusion was delayed for 2 weeks. In addition, 1 case of herpes zoster, 1 case of worsening preexisting palmar warts, and 1 case of mucosal candidiasis were observed.

Limitations of the study include the limited sample size and follow-up duration.

“Overall, anifrolumab is a promising therapeutic option for refractory CLE,” conclude the researchers.

Disclosure: Some 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.