Olokizumab plus methotrexate safe, efficacious through 106 weeks in rheumatoid arthritis
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Key takeaways:
- No new safety issues arose in a 106-week study of olokizumab plus methotrexate for rheumatoid arthritis.
- Clinical responses remained stable, were comparable between 2- and 4-week dosing intervals.
Olokizumab combined with methotrexate for the treatment of rheumatoid arthritis maintains its safety and efficacy profile through 106 weeks, according to data published in Annals of the Rheumatic Diseases.
“Olokizumab, a humanized monoclonal antibody, targets the interleukin (IL)-6 ligand directly, inhibiting IL-6-mediated trimer formation required for signal transduction rather than indirectly via IL-6 receptor inhibition, as do the inhibitors of IL-6 currently approved for RA,” Eugen Feist, MD, of the Helios Fachklinik Vogelsang/Gommern, in Germany, and colleagues wrote.
“[Olokizumab (OKZ)] in combination with methotrexate (MTX) was studied in the phase 3 CREDO clinical program encompassing three phase 3, randomized, double-blind, placebo (PBO)-controlled and active-controlled, multicenter 24-week studies,” they added. “OKZ improved the signs and symptoms of RA, physical function and health status in patients with moderately to severely active RA refractory to MTX or to anti-TNF. In addition, OKZ in combination with MTX in doses of 64mg every 2weeks or every 4 weeks demonstrated superiority to PBO and non-inferiority to adalimumab.”
To assess the long-term efficacy and safety of combination therapy with olokizumab (UCB, JSC R-Pharm) plus methotrexate in patients with RA, Feist and colleagues pooled data from three phase 3 trials, as well as an 82-week open-label extension study with a 20-week safety follow-up period. The analysis included 2,304 adults with active RA treated with olokizumab plus methotrexate either once every 2 weeks or once every 4 weeks.
The researchers assessed rates of serious adverse events, infections and other safety outcomes, as well as efficacy measures including ACR20/50/70 responses and DAS28 with C-reactive protein.
According to the researchers, there were no increases in the rates of any adverse events through 106 weeks. Clinical responses “remained stable” over the course of the open-label extension study and “were comparable” between the two dosing regimens, Feist and colleagues wrote.
The event rates per 100 patient-years among those who used olokizumab every 2 weeks vs. every 4 weeks, respectively, were as follows:
- serious adverse events: 9.57 and 9.13;
- serious infections: 2.95 and 2.34;
- gastrointestinal perforations: 0.58 and 0.38;
- major adverse cardiovascular events: 0.58 and 0.83; and
- malignancies: 0.45 and 0.5.
“The data show that no new safety issues arose during the [open-label extension] period when compared with the [randomized controlled trial] period,” Feist and colleagues wrote.
“The safety findings of long-term OKZ exposure were consistent with those seen in the shorter-term assessments and also those seen with IL-6R inhibitors,” the added. “The efficacy of OKZ was maintained through week 106.”
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