Promising Data on RA Drug

An experimental monoclonal antibody appears effective in treating rheumatoid arthritis.

New trial data released on June 8 at the Annual European Congress of Rheumatology (EULAR 2016) in London, UK show that subcutaneous sirukumab (CNTO 136/Jannsen-GlaxoSmithKline)— a human anti-interleukin (IL)-6 monoclonal antibody – appears effective in treating adults suffering from active moderate-severe rheumatoid arthritis (RA).

The Phase 3 trial comprised 1670 RA patients with inadequate response to treatment with disease-modifying anti-rheumatic drugs.

Patients receiving sirukumab in the randomized, double-blind group study, named SIRROUND-D, showed positive results in regard to both co-primary endpoints; inhibition of radiographic progression (joint destruction) at 52 weeks and improvement in RA signs and symptoms at week 16.

More specifically, patients receiving 50 mg of sirukumab every four weeks achieved a Heijde-Sharp score of 0.50 while those receiving 100 mg every two weeks scored 0.46 compared to a score of 3.69 for the placebo group. This scale measures the degree of structural damage, with higher scores indicating greater damage.

The results of the study were lauded by Tsutomu Takeuchi, MD, PhD, a professor in the division of rheumatology and clinical immunology at Tokyo’s Keio University of Medicine.

Quoted in a news release, Takuchi noted that treatments for RA that “may allow rheumatologists to limit the progression of the disease from causing permanent joint damage” are valuable. He added that he looked forward to seeing data testing the efficacy and safety of the drug on a broader and more diverse patient population.

The research was sponsored by Janssen Research & Development, LLC in collaboration with GlaxoSmithKline.

The Phase 3 clinical program investigating sirukumab encompasses four additional studies employing the treatment in combination therapy with conventional DAMRDS or as monotherapy. The comprehensive program involves over three thousand patients and constitutes the largest ever RA trial investigation of an anti-IL-6 biologic therapy.

Janssen’s Head of Immunology Development, Newman Yeilding, M.D., said that the company is working towards “global regulatory submissions this year.”

More than 23.5 million people worldwide are estimated to have RA. The debilitating chronic condition significantly affects quality of life with symptoms that include joint pain, swelling, and stiffness and can lead to destruction of joints.