This article is more than 5 years old. Information may no longer be current.
Patients with moderate-to-severe RA may benefit from olokizumab
Patients with moderate-to-severe rheumatoid arthritis who did not respond adequately to prior treatment with anti-tumor necrosis factor-alpha therapy may show improvements of symptoms with olokizumab, an interleukin-6 inhibitor, according to the results of a phase 2 study.
Researchers studied 119 patients from Japan, Korea and Taiwan with moderate-to-severe, active rheumatoid arthritis (RA) who were randomized to one of six treatment groups or placebo. Included patients received a stable dose of methotrexate for at least 6 weeks prior to study entry and continued methotrexate concomitantly with treatment, and had an inadequate response to at least one previous treatment with an anti-tumor necrosis factor-alpha agent. Patients were able to continue to receive up to 10 mg prednisone-equivalent daily in the presence of a stable dose for at least 14 days and with no changes during the study.
Twenty-eight of 32 patients completed 24 weeks of 60-mg olokizumab (UCB Japan) every 4 weeks, 15 of 16 patients each completed 60-mg olokizumab every 2 weeks or 120 mg every 4 weeks. Eleven of 13 patients completed 120-mg olokizumab every 2 weeks, and 12 of 13 completed 240-mg olokizumab every 4 weeks. Twenty-four of 29 patients received placebo, and all doses were administered subcutaneously.
Greater improvements in the Disease Activity Score in 28 Joints-C-reactive protein (DAS28-CRP) in least squares mean change from baseline in all 4-week cumulative dose groups were observed at week 12 compared to placebo, and the overall trend in dose-response reached statistical significance. Similar improvements were observed in the per-protocol set in the treatment group compared to placebo based on a reduction of more than 2 points on the DAS28-CRP score on average compared to a reduction of 0.55 in the placebo group. More patients in the treatment groups achieved a 20% or 50% disease improvement compared to placebo, while few reached a 70% response in any group.
All patients received at least two subcutaneous injections and most received 12 or more injections. Treatment-emergent adverse events occurred at similar rates among the treatment groups and compared to placebo, with no severe adverse reactions in any group. The most common adverse events were infections in 31.3% to 43.8% of patients in the treatment groups and in 20.7% of the patients who received placebo. Gastrointestinal symptoms were reported in 23.1% to 28.1% of the treatment groups and in 20.7% of patients in the placebo group. – by Shirley Pulawski
Disclosure: Takeuchi reports grants, speaker fees and/or consulting fees from AbbVie, Astellas Pharma, AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Eisai, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, Novartis Pharma, Pfizer Japan, Santen Pharmaceutical, Takeda Pharmaceutical, Teijin Pharma, Asahikasei Pharma, Taisho Toyama Pharmaceutical and SymBio Pharmaceuticals. Please see the full study for a list of all other authors’ relevant financial disclosures.