Janssen reports positive long-term results from Phase III trial of sirukumab for RA

15th June 2017 (Last Updated June 15th, 2017 18:30)

Janssen-Cilag International (Janssen) has reported positive long-term results from the Phase III SIRROUND-T clinical trial of sirukumab to treat patients with rheumatoid arthritis (RA).

Janssen-Cilag International (Janssen) has reported positive long-term results from the Phase III SIRROUND-T clinical trial of sirukumab to treat patients with rheumatoid arthritis (RA).

Sirukumab is a fully human, monoclonal IgG1 kappa antibody currently being developed to selectively block circulating IL-6, which is reported to play a role in autoimmune disorders.

The results indicated improvement in the signs and symptoms of moderately to severely active RA through 52 weeks of treatment in adults who showed an inadequate response and / or were intolerant to treatments with anti-tumour necrosis factor (TNF)-alpha.

The randomised, double-blind, placebo-controlled Phase III trial assessed the efficacy and safety of 50mg every four weeks and 100mg of sirukumab every two weeks in 878 adult patients.

Janssen EMEA European medical affairs immunology director Bogdana Coudsy said: “The data presented at this year’s congress support the profile of sirukumab in the treatment of moderately to severely active adult rheumatoid arthritis.

"We believe that sirukumab has the potential to offer an important new alternative treatment for patients."

“While patient outcomes have improved in the last few decades with the advent of new RA treatments, there are still many patients whose disease is not effectively managed and continues to progress.

“We believe that sirukumab has the potential to offer an important new alternative treatment for patients.”

It was found that 54.3% of patients administered with 50mg of sirukumab and 59.3% of patients given 100mg of sirukumab demonstrated a minimum improvement of 20% in the signs and symptoms.

The findings also showed clinically meaningful improvement in quality of life measures from baseline through to week 52.

A post-hoc analysis from four sirukumab Phase III trials indicated that the product consistently increased haemoglobin levels in adults with moderately to severely active RA, in turn minimising the proportion of patients with anaemia at week 16.

The SIRROUND clinical programme includes five Phase III trials of subcutaneous 50mg and 100mg worth of sirukumab as a monotherapy or in combination with conventional disease-modifying antirheumatic drugs (DMARDs).