In the Journals

Satralizumab reduces relapse in some patients with neuromyelitis optica spectrum disorder

Satralizumab added to immunosuppressant treatment may reduce relapse in some cases of neuromyelitis optica spectrum disorder.

The phase 3, randomized, double-masked, placebo-controlled SAkuraSky trial included 83 patients randomly assigned 1:1 to receive satralizumab (Genentech) or placebo in addition to baseline immunotherapy treatment. Eight of 41 patients (20%) who received satralizumab relapsed compared with 18 of 42 patients (43%) who received placebo.

Satralizumab is a monoclonal antibody that targets the interleukin-6 receptor, which is thought to be a key driver of the inflammation that occurs in neuromyelitis optica spectrum disorder (NMOSD).

“The positive results from the pivotal SAkuraSky study of satralizumab support the hypothesis that IL-6 plays a key role in NMOSD, which is a debilitating and potentially fatal condition,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in a press release. “Satralizumab has shown robust efficacy sustained for 144 weeks across a broad patient population in two phase 3 studies, whether given as a monotherapy or in combination with baseline therapy. We’re encouraged that satralizumab may soon provide a new treatment option for people living with NMOSD.”

A subgroup analysis found that subjects who were AQP4-IgG-seropositive and treated with satralizumab had a lower risk for relapse than those treated with placebo, while there was insufficient evidence regarding relapse rates in those who were AQP4-IgG-seronegative. There were 55 AQP4-IgG-seropositive patients in the trial, with relapse occurring in 11% of those treated with satralizumab and 43% of those treated with placebo. Of the 28 AQP4-IgG-seronegative patients, the relapse rate was 36% when treated with satralizumab and 43% when treated with placebo.

“The drug may be ineffective in the latter group, or the discrepancy between seropositive patients and seronegative patients may be explained by the few seronegative patients who were included as a result of the trial design,” the study authors wrote.

The treatment and placebo groups showed no significant differences in pain and fatigue, the trial’s secondary endpoints.

“Among adolescent and adult patients with NMOSD, satralizumab added to baseline immunosuppressant treatment led to a lower risk of relapse than placebo, particularly among AQP4-IgG-seropositive patients,” the authors wrote. “Longer and larger trials are necessary to determine the efficacy, durability and safety of satralizumab and to investigate its effect in comparison with other treatments for NMOSD.” – by Rebecca L. Forand

 

Disclosures: Yamamura reports receiving grants from Chugai Pharmaceutical during the conduct of the study and, outside the submitted work, grants and personal fees from Chugai, grants and personal fees from Biogen, grants and personal fees from Novartis, grants from Teva, grants and personal fees from Chiome Bioscience, personal fees from Takeda, personal fees from Sumitomo Dainippon, personal fees from Mitsubishi Tanabe, personal fees from Bayer, personal fees from Japan Blood Products Organization, personal fees from Otsuka, personal fees from Kissei, personal fees from Daiichi Sankyo, grants and personal fees from Miraca Holdings, grants from Ministry of Education of Japan, grants from Ministry of Health, Welfare and Labor of Japan, and grants from Japan Agency for Medical Research and Development. Please see the study for all other authors’ relevant financial disclosures.

Satralizumab added to immunosuppressant treatment may reduce relapse in some cases of neuromyelitis optica spectrum disorder.

The phase 3, randomized, double-masked, placebo-controlled SAkuraSky trial included 83 patients randomly assigned 1:1 to receive satralizumab (Genentech) or placebo in addition to baseline immunotherapy treatment. Eight of 41 patients (20%) who received satralizumab relapsed compared with 18 of 42 patients (43%) who received placebo.

Satralizumab is a monoclonal antibody that targets the interleukin-6 receptor, which is thought to be a key driver of the inflammation that occurs in neuromyelitis optica spectrum disorder (NMOSD).

“The positive results from the pivotal SAkuraSky study of satralizumab support the hypothesis that IL-6 plays a key role in NMOSD, which is a debilitating and potentially fatal condition,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in a press release. “Satralizumab has shown robust efficacy sustained for 144 weeks across a broad patient population in two phase 3 studies, whether given as a monotherapy or in combination with baseline therapy. We’re encouraged that satralizumab may soon provide a new treatment option for people living with NMOSD.”

A subgroup analysis found that subjects who were AQP4-IgG-seropositive and treated with satralizumab had a lower risk for relapse than those treated with placebo, while there was insufficient evidence regarding relapse rates in those who were AQP4-IgG-seronegative. There were 55 AQP4-IgG-seropositive patients in the trial, with relapse occurring in 11% of those treated with satralizumab and 43% of those treated with placebo. Of the 28 AQP4-IgG-seronegative patients, the relapse rate was 36% when treated with satralizumab and 43% when treated with placebo.

“The drug may be ineffective in the latter group, or the discrepancy between seropositive patients and seronegative patients may be explained by the few seronegative patients who were included as a result of the trial design,” the study authors wrote.

The treatment and placebo groups showed no significant differences in pain and fatigue, the trial’s secondary endpoints.

“Among adolescent and adult patients with NMOSD, satralizumab added to baseline immunosuppressant treatment led to a lower risk of relapse than placebo, particularly among AQP4-IgG-seropositive patients,” the authors wrote. “Longer and larger trials are necessary to determine the efficacy, durability and safety of satralizumab and to investigate its effect in comparison with other treatments for NMOSD.” – by Rebecca L. Forand

 

Disclosures: Yamamura reports receiving grants from Chugai Pharmaceutical during the conduct of the study and, outside the submitted work, grants and personal fees from Chugai, grants and personal fees from Biogen, grants and personal fees from Novartis, grants from Teva, grants and personal fees from Chiome Bioscience, personal fees from Takeda, personal fees from Sumitomo Dainippon, personal fees from Mitsubishi Tanabe, personal fees from Bayer, personal fees from Japan Blood Products Organization, personal fees from Otsuka, personal fees from Kissei, personal fees from Daiichi Sankyo, grants and personal fees from Miraca Holdings, grants from Ministry of Education of Japan, grants from Ministry of Health, Welfare and Labor of Japan, and grants from Japan Agency for Medical Research and Development. Please see the study for all other authors’ relevant financial disclosures.