Russian rival to GSK/Janssen’s RA drug revealed

GlaxoSmithKline and Janssen kicked off the European League Against Rheumatism (EULAR) conference with strong phase 3 data from their rheumatoid arthritis (RA) drug, sirukumab – but a Russian rival from R-Pharm is also showing promise in mid-stage.

GSK and Janssen said the SIRROUND-D study achieved its two main goals in adults with moderately to severely active rheumatoid arthritis – paving the way for a filing planned in the third quarter.

Sirukumab, an anti-interleukin (IL)-6 monoclonal antibody is a potential rival to AbbVie’s big-selling Humira (adalimumab) in RA, although it has a different mechanism of action.

In the trial involving more than 1,600 people with RA, inhibition of joint destruction was significantly greater among sirukumab-treated patients after a year with 50mg and 100mg doses, compared with placebo.

There was at least a 20% improvement in RA signs and symptoms, as measured by American College of Rheumatology criteria at 16 weeks, in 54.8% and 53.5% of patients receiving sirukumab 50mg and 100mg respectively, compared with 26.4% of those in the placebo group.

All secondary endpoints were met with statistical significance in both doses.

SIRROUND-D is one of several studies involving sirukumab – Janssen and GSK are also conducting SIRROUND-H comparing sirukumab with Humira, but findings were not announced at EULAR.

Russia’s R-Pharm described the phase 2 data for its rival olokizumab, which also targets IL-6, as “promising”. Data from the randomised controlled trial and open label extension showed that patients treated with olokizumab had a greater improvement in patient-reported outcomes by week 12 compared with a placebo. Results were descriptively in line with Roche’s RoActemra (tocilizumab).

Improvements were maintained to week 48 of the extension phase, not only in patients treated with olokizumab, but also those who originally received the Roche drug and switched to olokizumab at the start of the extension phase.

A phase 3 programme will evaluate the safety and efficacy of olokizumab in patients with inadequate response to methotrexate or TNF therapies. It will include three randomised trials (CREDO 1,2,3) followed by an open-label extension (CREDO 4) for patients completing treatment.

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Pfizer re-files Xeljanz in Europe for rheumatoid arthritis

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