Novel and Emerging Treatments in Relapsing-Remitting MS
Novel and Emerging Treatments in Relapsing-Remitting MS
In the large, multicenter phase II trial, ocrelizumab demonstrated a favorable short-term safety profile. Infusion-related adverse events were more frequently reported with ocrelizumab (35% with 600 mg ocrelizumab, 44% with 2000 mg ocrelizumab, 9% with placebo) with the first treatment, but with the second treatment, infusion-related adverse events were similar across ocrelizumab and placebo arms.
From weeks 24 to 48, SAEs were similar across all treatment arms, and rates of serious infectious adverse events were similar for patients in both ocrelizumab arms versus placebo. No opportunistic infections or clinically relevant laboratory changes were observed. One death was reported in the high-dose ocrelizumab treatment arm because of acute-onset thrombotic microangiopathy, and the contribution of ocrelizumab cannot be excluded.
Noteworthy is that the development of ocrelizumab in rheumatoid arthritis was suspended because of high rates of serious opportunistic infections, some which were fatal. In contrast to ocrelizumab's use in RRMS, in patients with rheumatoid arthritis, ocrelizumab was administered concomitantly with other potent immunosuppressives and corticosteroids, which is not done in RRMS. Nonetheless, a high degree of vigilance is necessary in light of this prior experience with ocrelizumab. The results of the phase III trials of ocrelizumab in MS will be important to establish this agent's longer-term safety profile.
Ocrelizumab: Safety
In the large, multicenter phase II trial, ocrelizumab demonstrated a favorable short-term safety profile. Infusion-related adverse events were more frequently reported with ocrelizumab (35% with 600 mg ocrelizumab, 44% with 2000 mg ocrelizumab, 9% with placebo) with the first treatment, but with the second treatment, infusion-related adverse events were similar across ocrelizumab and placebo arms.
From weeks 24 to 48, SAEs were similar across all treatment arms, and rates of serious infectious adverse events were similar for patients in both ocrelizumab arms versus placebo. No opportunistic infections or clinically relevant laboratory changes were observed. One death was reported in the high-dose ocrelizumab treatment arm because of acute-onset thrombotic microangiopathy, and the contribution of ocrelizumab cannot be excluded.
Noteworthy is that the development of ocrelizumab in rheumatoid arthritis was suspended because of high rates of serious opportunistic infections, some which were fatal. In contrast to ocrelizumab's use in RRMS, in patients with rheumatoid arthritis, ocrelizumab was administered concomitantly with other potent immunosuppressives and corticosteroids, which is not done in RRMS. Nonetheless, a high degree of vigilance is necessary in light of this prior experience with ocrelizumab. The results of the phase III trials of ocrelizumab in MS will be important to establish this agent's longer-term safety profile.
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