Monoclonal Antibody Yields Response Among Patients With SLE

Anifrolumab may be an effective treatment option for patients with systemic lupus erythematosus (SLE), according to results of the new phase 3 TULIP-2 trial.

This determination was made after the researchers found that the human monoclonal antibody to type I interferon receptor subunit 1 met the trial’s primary end point, which was a response at week 52 defined by the British Isles Lupus Assessment Group (BILAG)–based Composite Lupus Assessment (BICLA).

The researchers randomly assigned 180 participants with SLE to receive intravenous anifrolumab, 300 mg, and 182 participants to receive placebo every 4 weeks for 48 weeks.

Results showed that 47.8% of participants in the anifrolumab group and 31.5% of participants in the placebo group had a BICLA response. A BICLA response required the following:

• A reduction in any moderate-to-severe baseline disease activity and no worsening in any of 9 organ systems in the BILAG index
• No worsening on the Systemic Lupus Erythematosus Disease Activity Index 
• No increase of 0.3 points or more in the score on the physician global assessment of disease activity (on a scale from 0 [no disease activity] to 3 [severe disease])
• No discontinuation of the trial intervention
• No use of medications restricted by the protocol

As a secondary end point, the researchers also assessed for a BICLA response among participants with a high interferon gene signature. Among this participant population, 48.0% of those in the anifrolumab group and 30.7% of those in the placebo group had a BICLA response. 

Anifrolumab also demonstrated a reduction in both the glucocorticoid dose and skin disease severity. However, the medication did not yield a benefit in counts of swollen and tender joints or the annualized flare rate.

Of the participants who received anifrolumab, 7.2% developed herpes zoster and 12.2% developed bronchitis. According to the study authors, more participants in the anifrolumab group than in the placebo group developed herpes zoster. Additionally, 1 participant in the anifrolumab group died from pneumonia.

“Monthly administration of anifrolumab resulted in a higher percentage of patients with a response (as defined by a composite end point) at week 52 than did placebo, in contrast to the findings of a similar phase 3 trial involving patients with SLE that had a different primary end point,” the researchers concluded.

—Colleen Murphy

Reference:

Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus [published online December 18, 2019]. N Engl J Med. doi:10.1056/NEJMoa1912196.