Satralizumab may reduce risk of neuromyelitis optica spectrum disorder relapse
Patients treated with satralizumab as monotherapy were at less risk for neuromyelitis optica spectrum disorder relapse compared with patients treated with placebo, according to a study.
“A recently published clinical trial of satralizumab, compared to placebo, demonstrated that blocking of IL-6 receptors is highly effective at preventing future relapses. Furthermore, satralizumab was well tolerated with a good safety profile that makes it an attractive long-term treatment option for NMOSD patients,” study co-author Anthony Traboulsee, MD, told Healio/OSN.
Researchers evaluated the safety and efficacy of satralizumab (Genentech), a monoclonal antibody that targets the interleukin-6 receptor, as a monotherapy in patients with neuromyelitis optica spectrum disorder (NMOSD). The phase 3, double-blind, placebo-controlled, parallel-group trial included 95 adults with aquaporin-4 antibody seropositive or seronegative neuromyelitis randomly assigned 2:1 to receive satralizumab 120 mg or placebo. Patients were treated subcutaneously at weeks zero, 2, 4 and every 4 weeks after.
“The first presentation of NMOSD is often severe optic neuritis, and ophthalmologists are the front line in early diagnosis and treatment. Serology for autoantibodies to aquaporin-4 will distinguish NMOSD from multiple sclerosis, which is a more common cause of optic neuritis,” Traboulsee said.
The study included 63 patients receiving satralizumab and 32 receiving a placebo. In total, 35 relapses were observed in the patient cohort. Nineteen of 63 (30%) patients treated with satralizumab had a relapse compared with 16 of 32 (50%) patients receiving placebo, a statistically significant difference (P = .018). Placebo treated patients experienced a shortened time to relapse and a higher withdrawal rate compared with patients treated with satralizumab, according to the study.
In the aquaporin-4 seropositive subgroup, nine of 41 patients receiving satralizumab compared with 13 of 23 receiving placebo experienced a relapse. In the seronegative subgroup, 10 of 22 patients receiving satralizumab compared with three of nine receiving placebo experienced a relapse.
The rate of adverse events in the satralizumab cohort was 473.9 events per 100 patient-years compared with 495.2 events per 100 patient-years in the placebo group.
“Once diagnosed, NMOSD patients need to go on lifelong immune-suppressing therapy. Prior to phase 2/3 trials, commonly used therapies included chronic prednisone, azathioprine, mycophenolate mofetil and rituximab,” Traboulsee said. – by Robert Linnehan
Disclosures: Traboulsee reports grants, personal fees and non-financial support from Chugai Pharmaceutical. Please see the full study for a list of all other authors’ relevant financial disclosures.
Editor's note: This article has been corrected to reflect that patients in the study were treated with satralizumab as monotherapy vs. placebo. Healio/OSN regrets the error.