Ritifilimab is superior to placebo in reducing joint tenderness and swelling in lupus

According to phase 2 trial data published in , ritifilimab is superior to placebo in reducing joint tenderness and swelling in patients with systemic lupus erythematosus. new england journal of medicine.

“Ritifilimab is a humanized IgG1 administered subcutaneously. monoclonal antibody Binds BDCA2, resulting in downregulation of type I interferon, cytokine, and chemokine production. ” Richard A. Fury, MD chief of rheumatology Northwell Health of New York and co-author writes. “In a phase 1 trial involving 12 participants with SLE and cutaneous lupus erythematosus, the biological activity of ritifilimab was demonstrated by an attenuated interferon signature in the blood and a regulated type I interferon-inducing protein in the skin. rice field.

Richard A. Fury

“Here we report the findings of Part A. [of the phase 2 trial]involved Participants in SLE He had both active arthritis and a rash,” they added.

A phase 2, two-part, multicenter, double-blind, randomized, controlled trial to investigate the safety and efficacy of ritifilimab (BIIB059, Biogen) in patients with SLE. A LILAC study was conducted. This trial included patients from her age 18 to her age 75, who had SLE according to the 1997 American College of Rheumatology classification criteria. Patients were required to have a written diagnosis 24 weeks prior to her agreeing to participate in the study.

Patients to be included were also required to demonstrate an antinuclear antibody (ANA) titer of ≥1:80, an anti-double-stranded DNA antibody level of 30 IU per mL, or both. Additionally, the patient was allowed to enroll while taking prednisone at a dose of less than her 20 mg daily.

This trial included two different protocols for enrollment. The initial protocol allowed patients with active skin disease at the time of screening and randomization. Protocol 2, on the other hand, included patients with one or more active skin lesions and active arthritis. In the initial protocol, patients were randomized in her 1:1:1:1 ratio, but to delay subject recruitment, the trial was reconfigured before unblinding, the authors said. writes.

In protocol 2, patients were randomized 1:1 following a 28-day screening process. Patients in this protocol received ritifilimab 450 mg or placebo at weeks 0, 2, 4, 8, 12, 16, and 20. After a 24-week dosing period, the patient was followed for her 12-week safety observation period.

After the protocol change, the primary endpoint was change from baseline in total number of active joints at 24 weeks. Secondary endpoints included a 50% or greater reduction from baseline in skin-related disease activity. Global change in SLE disease activity was included as an additional secondary endpoint. Investigators monitored adverse events, serious adverse events, and changes in laboratory numbers.

In total, the study included 132 patients, of whom 64 were treated with litifilimab 450 mg, 6 received litifilimab 150 mg, 6 received litifilimab 50 mg, and 56 received placebo. rice field. However, the analysis only included patients who received ritifilimab 450 mg or placebo, the authors wrote.

According to the researchers, the least squares mean change from baseline to week 24, as measured by total number of active joints, was -15.0±1.2 for ritifilimab and -11.6±1.3 for placebo (mean difference = – 3.4; 95% CI, –6.7 to –0.2). Regarding safety, litifilimab was more commonly associated with adverse events, including two cases of herpes zoster and one case of herpes keratitis, the authors wrote.

“In this phase 2, randomized, placebo-controlled trial in participants with SLE, arthritis, and active skin disease, ritofilimab at a dose of 450 mg reduced the total number of active joints from baseline to was superior to placebo in the change in .24,” write Furie and colleagues. “Larger, longer-term trials are needed to determine the efficacy and safety of ritofilimab. SLE patient”

References:

Furie R, et al. J Clin Invest. 2019; doi:10.1172/JCI124466.