Nine of the 10 participants with NMOSD included in the case series have remained relapse-free after switching to satrlizumab from previous therapy.
New data from an ongoing retrospective case series showed that patients with neuromyelitis optica spectrum disorder (NMOSD), including those with concomitant autoimmune comorbidities, had a more beneficial response on satralizumab (Enspryng; Genentech) after switching from previous treatments.1 The cases provided valuable real-world data on responses of patients on satralizumab after previous treatment with biologics such as rituximab(Rituxan; Genentech) and conventional immunosuppressive therapies.
Nine of the 10 patients included the analysis were relapse free after being treated with satralizumab, despite reports of confirmed or suspected relapses in some patients because of previous treatments. Notably, patients maintained disease control and few adverse events were reported, with leukopenia being the most common. There were no patients that discontinued the use of satralizumab permanently because of ineffectiveness or intolerance.
The results were presented as a poster at the annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forumheld February 23-25, 2023, in San Diego, California, by lead author Hesham Abboud, MD, PhD, director of the Multiple Sclerosis and Neuroimmunology Program at University Hospitals Cleveland Medical Center. In this case series, researchers explored the responses of adult patients with AQP4-IgG+ NMOSD to satralizumab who received biologics or conventional immunosuppressive therapies previously for NMOSD in clinical practice.
Data was obtained from healthcare providers in the United States on the patients on satralizumab for at least 6 months, with the collection of cases still ongoing. Records reported on the patient’s characteristics, examination findings, diagnostic tests, treatment response and satralizumab-related adverse events. Also included in the report series were patients who received biologics or immunosuppressants (other than corticosteroids) prior to satralizumab. Overall recruitment of the study included 10 patients aged between 23 and 69 years, 5 self-identified as Black/African American, 3 as White, and 2 as Hispanic. A majority of the patients were female and approximately half had autoimmune comorbidities. Duration of the NMOSD disease ranged from 3 to 14 years with symptoms including optic neuritis and transverse myelitis.
Seven patients received rituximab, 2 with concomitant mycophenolate mofetil (MMF), 2 MMF alone and 1 eculizumab as the last NMOSD treatment prior to satralizumab for 14 to 21 months. Reasons for initiation of satralizumab for the patients included treatment intolerance and inadequate disease control. Additionally, 7 patients received satralizumab monotherapy, and 3 patients received satralizumab in combination with MMF.
Considering the case reports, limitations included the small number of patients, partially missing data, and the retrospective design, as well as the duration of treatment since it was shorter than the duration of previous NMOSD treatment in all patients. The authors therefore noted that the comparison of the number of relapses with each treatment should be evaluated with caution.
All told that the treatment was well tolerated, and that the outcomes align with the efficacy and safety outcomes with satralizumab in phase 3 SAkura clinical trials. Authors noted that future research of a larger number of patients with NMOSD will help to further elucidate the clinical response to satralizumab.
Another study on satralizumab presented at 2023 ACTRIMS demonstrated a high proportion of adult patients with AQP4-IgG+ NMOSD who remained free of relapse with a consistently low annualized relapse rate (ARR) over 4.6 years of satralizumab exposure from the SAkuraMoon trial (NCT04660539).2 After 4.6 years, 72% (95% CI, 62-80%) of satralizumab-treated patients were free from investigator-determined protocol-defined relapse (iPDR). At the same time, 91% (95% CI, 84-96) of patients were free from severe iPDR, and 85% (95% CI, 75-91%) had no sustained Expanded Disability Status Scale (EDSS) worsening.
In August 2020, the FDA approved satralizumab, a humanized monoclonal recycling antibody against the IL-6 receptor, for use in adult patients with AQP4-IgG+ NMOSD which is the third targeted treatment for this population and the first eligible for at-home administration.3 The approval was based on robust data from the phase 3 SAkuraStar (NCT02073279) and SAkuraSky (NCT02028884) clinical trials, which combined included more than 170 patients who were randomly assigned to receive satralizumab 120 mg or placebo. In SAkuraSky, patients added treatment to baseline immunosuppressive therapy.