Positive Phase III results for R-Pharm's IL-6 inhibitor olokizumab

In the framework of the annual ACR Convergence 2021, Russian drugmaker R-Pharm presented successful results of olokizumab in two randomized clinical trials of phase III global research program – CREDO (Clinical RhEumatoid Arthritis Development of Olokizumab) – CREDO 2 and CREDO 3.

In CREDO 2, the primary endpoint ACR20 response rate at week 12 was achieved in 326 subjects (70.3%) with olokizumab every two weeks, 342 (71.4%) – with olokizumab every four weeks, 309 (66.9%) with adalimumab and 108 (44.4%) in the placebo group. The statistical significance of these results was high (p<0.0001).

In CREDO 3, ACR20 response rates were 60.9% in olokizumab every two weeks, 59.6% in olokizumab every four weeks and 40.6% in placebo (p<0.01 for both comparisons). There were significant differences in achievement of Disease Activity Score 28-joint count C-reactive protein <3.2 between olokizumab-treated arms and placebo. The improvements in efficacy and patient reported outcomes were maintained throughout 24-weeks and noted after Week 16 in patients who switched from placebo.