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.
Patients with NMOSD who experienced a relapse
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.