Sarilumab Superior to Humira as Monotherapy for Active RA

Results from a recent study presented at the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP)  meeting showed that sarilumab was superior to Humira (adalimumab; Abbvie) as monotherapy in patients with active rheumatoid arthritis (RA) who are not good candidates for combination therapy.

Results of a phase 3, randomized, double-blind study show that patients with active RA treated with sarilumab monotherapy had a significantly greater decrease in measures of disease activity compared to those treated with Humira monotherapy.

Gerd Burmester, MD, professor of medicine in the department of rheumatology and clinical immunology at the University Medicine Berline, Free University and Humboldt University Berlin in Germany, presented the study results.

The study was undertaken to evaluate the safety and efficacy of sarilumab monotherapy compared to Humira monotherapy in adult patients with active RA who are not good candidates for combination therapy with sarilumab and a nonbiologic disease-modifying antirheumatic drug.

“Approximately 30% of RA patients either do not tolerate or have contraindications to methotrexate or do not want to take it due to some, often minor, constitutional symptoms,” Dr Burmester said. “In these patients, biologic monotherapy without methotrexate is an important option.”

The study included 369 patients with active RA who received 24 weeks of either subcutaneous sarliumab (200 mg every 2 weeks) or Humira (40 mg every 2 weeks). At week 16, patients with inadequate response could increase dosing to weekly Humira, or matching placebo.

The change from baseline in disease activity score (DAS28-ESR) at week 24 was the primary endpoint of the study. Secondary endpoints included clinical disease activity index (CDAI), ACR20/50/70 response, and health assessment questionnaire disability index (HAQ-DI).

At week 24, the study found a significant reduction in disease activity associated with sarilumab monotherapy versus Humira monotherapy as measured by DAS28-ESR (P < .0001) and a greater incidence of DAS28-ESR remission (26.6% vs 7.0%, P < .0001, respectively).

Sarilumab also showed superiority over Humira in significantly greater ACR/20/50/70 responses as well as improvements in physical function as shown by greater improvements in the HAQ-DI. These results included patients who switched to weekly Humira.

Although not statistically significant, the study also found that patients treated with sarilumab were twice as likely to achieve CDAI remission compared to those treated with Humira at 24 weeks (7.1% vs 2.7%, P  = .04).

In terms of safety, the study found that the incidence of adverse events were similar between the two groups. Overall, 64% of patients had an adverse event, with serious adverse events reported in 5% of patients treated with sarilumab and 7% in those treated with Humira. The incidence of serious infection were also similar between the two groups (29% and 28%, respectively).

Adverse events more common with sarilumab were neutropenia and injection site reactions, whereas headache and worsening RA were more common with Humira.

“There were no different safety signals between drugs, with the exception of a neutropenia in some sarilumab treated patients,” said Dr. Burmester, who added that the study found no association between neutropenia and increased incidence of infections.

“This study shows that sarilumab was superior to adalimumab in practically all endpoints,” Dr Burmester said. —Mary Beth Nierengarten