This article is more than 5 years old. Information may no longer be current.
Sirukumab monotherapy shows comparable efficacy to Humira in RA
Click Here to Manage Email Alerts
Although sirukumab monotherapy demonstrated greater improvements than adalimumab monotherapy among patients with rheumatoid arthritis when measured using erythrocyte sedimentation rate, the two treatments were generally similar in terms of participants who achieved the ACR50 response rate.
“This large, international, randomized, controlled trial was conducted to assess the efficacy and safety of sirukumab used as monotherapy in patients with moderately to severely active RA, who were unable to continue [methotrexate] for safety reasons or were inadequate responders to [methotrexate],” Benjamin Hsu, MD, senior director of immunology development for Janssen Research and Development, told Healio Rheumatology.
For the 68-week phase 3 study, which included a 52-week treatment period, researchers recruited 559 patients across 102 centers in the United States, Europe, Latin America and South Africa from April 2014 to May 2015. Patients were randomly grouped into one of three cohorts, with 187 selected to receive 100 mg of subcutaneous sirukumab (Janssen) every 2 weeks; 186 treated with 50 mg of sirukumab every 4 weeks; and 186 receiving 40 mg of adalimumab (Humira, AbbVie) every 2 weeks.
The primary endpoints were change in DAS28 using erythrocyte sedimentation rate (ESR), from baseline to week 24, as well as the proportion of patients who achieved an ACR50 response.
According to the researchers, there were significantly greater improvements in mean DAS28, using ESR, among patients who received 100 mg of sirukumab every 2 weeks (–2.96), compared with those who received 40 mg of adalimumab every 2 weeks (–2.19; P < .001). Patients treated with 50 mg of sirukumab every 4 weeks also demonstrated significantly greater improvement in DAS28 (–2.58), compared with those in the adalimumab group (P = .013). However, ACR50 response rates among the two sirukumab groups — 35.3% in those treated with 100 mg and 26.9% in those who received 50 mg — were comparable with the 31.7% response rate in the adalimumab cohort.
“Disease activity scores improved significantly among patients receiving both doses of sirukumab monotherapy compared with those receiving adalimumab, and although sirukumab-treated patients demonstrated clinically relevant ACR50 improvements, the difference in ACR50 response rates results did not reach statistical significance,” Hsu said. “We observed treatment with sirukumab monotherapy to result in rapid and sustained improvement in signs and symptoms of RA, comparable to those achieved with adalimumab monotherapy.”
Hsu added that the safety of sirukumab monotherapy was found to be consistent with the known safety profile of IL-6 pathway inhibitors.
“There were no new safety findings,” he said. “Overall, improvements in signs and symptoms of RA, physical function and patient-reported outcomes were found to be generally similar between sirukumab monotherapy and adalimumab monotherapy.” – by Jason Laday
Disclosure: The researchers report funding from Janssen Research and Development, in collaboration with GlaxoSmithKline. Hsu reports being an employee and shareholder of Janssen Research and Development. See the full study for additional researchers’ disclosures.
Click Here to Manage Email Alerts