Novel Lupus Agent a Success in Phase II Trial, According to Research

A researcher recently reported that a phase II trial of a monoclonal antibody called BIIB059, which hinders the production of interferon type 1, exhibited effectiveness in patients who had active systemic lupus erythematosus or SLE.

According to Great Neck, New York-based Zucker School of Medicine at Hofstra/Northwell's Richard Furie, MD, the primary endpoint of the research, change from baseline in total active combined count between the BIIB059 and the placebo groups, a substantial variance was found among patients randomized to "BIIB059, at -15," compared with patients who were provided with placebo, at -16, "for a -3.4 mean difference."

Furie also said during the plenary session at the American College of Rheumatology virtual meeting, the type 1 interferons, which are considered as "inflammatory mediators" predominantly produced by "plasmacytoid dendritic cells," innate immune system's components, have been "implicated in the pathogenesis of SLE."

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The Plasmacytoid Dendritic Cells

Numerous lines of evidence back such an association, which includes elevated alpha-interferon levels in lupus patients, interferon gene signatures existing in most patients, recent results from clinical tests that demonstrate clinical efficacy of "anifrolumab," a monoclonal antibody that hinders the interferon pathway "by blocking the type 1 interferon receptor," described the researcher.

Meanwhile, the plasmacytoid dendritic cells in the control of the bulk of type 1 interferon production in lupus are found to be abundant in the lupus patients' skin. They are also found in other organs like the kidney, for one.

As indicated in the research, BIIB059 binds blood dendritic cell antigen 2, which, upon ligation and internalization outcomes in the prevention of the "production of the interferon type 1, as well as the other inflammation cytokines and chemokines."

Single-Dose Treatment

During a phase I study of 12 patients who had cut cutaneous lupus and were given a single dose of BIIB059 or placebo for treatment, there was an interferon gene signature prevention in peripheral blood, as well as clinical improvement in skin activity.

The current research randomized more than 60 patients to the BIIB059 group and more than 50 to the placebo group. The main endpoint was changed in "total active joint account," which was the totality of tender and swollen joints on the 24th week.

During the conduct of the study, patients needed to have at least four tender and swollen joints, respectively, active skin disease, and "positive antinuclear antibodies and, or, elevated anti-ds-DNA antibodies."

Furthermore, the treatment included 450 milligrams of BIIB059 or placebo every four weeks, with the last dose on the 20th week. Relatively steroids needed to be tapered to 10 milligrams or 7.5 milligrams per day between weeks four and 12.

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50-Percent Improvement

The research also showed, on a "key secondary endpoint, the SLE Responder Index," there was a point differential of 26 percent between the BIIB059 and placebo groups.

More so, on an additional SLE Responder Index, a 50-percent improvement of Cutaneous Lupus Erythematosus Disease Area and Severity Index, the reaction rate was higher in the BIIB059 group. However, this, according to the study, was not statistically substantial.

The general rates of adverse occurrences were more than 59 percent in the BIIB059 group, while the placebo group had more than 67 percent.

Meanwhile, serious adverse occurrences, the research specified, were reported in 5.3 percent and 10.7 percent of the BIIB059 and placebo groups. As three adversative events in the latter-mentioned group resulted in study withdrawal, no occurrences in the active treatment group resulted in withdrawal from the study.

These efficacy findings, as well as the observed safety profile, Furie concluded, back the "continued development of BIIB059 as a treatment for SLE."

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