Drug updated on 4/16/2024
| Dosage Form | Injection (subcutaneous; 280 mg/2 mL [140 mg/mL] in a single-dose vial) |
| Drug Class | Neonatal Fc receptor blockers |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of generalized myasthenia gravis in adults patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody-positive.
Summary
- Rozanolixizumab-noli (Rystiggo) is indicated for the treatment of generalized myasthenia gravis in adult patients who are either acetylcholine receptor or muscle-specific tyrosine kinase antibody-positive.
- Information about Rystiggo was derived from a single study, which was a randomized controlled trial named MycarinG.
- This trial involved adults aged 18 years and above with AChR or MuSK autoantibody-positive generalized myasthenia gravis. It compared the effects of rozanolixizumab at doses of 7 mg/kg and 10 mg/kg with placebo.
- In terms of efficacy, rozanolixizumab demonstrated clinically meaningful improvements in MG-ADL scores from baseline to day 43, indicating better outcomes in symptom control relative to placebo. Both the 7 mg/kg and 10 mg/kg doses showed significant improvement.
- Regarding safety profile, treatment-emergent adverse events were observed more frequently among participants receiving rozanolixizumab than those receiving placebo. However, significant adverse events occurred at similar rates across all groups without any reported deaths during the study period.
- Although there's no specific comparative data on safety and efficacy with other treatments within this study for direct comparison against other options for treating generalized myasthenia gravis; however, considering conventional therapy limitations such as increased infection risk & inadequate symptom control - Rystiggo presents itself as a potentially valuable addition due to its novel mechanism through neonatal Fc receptor inhibition.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rystiggo (rozanolixizumab-noli) Prescribing Information. | 2023 | UCB, Inc., Smyrna, GA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. | 200Subjects F: 60% M: 40% | 2023 | The Lancet Neurology |
Sex Distribution:
F:60%
M:40%
200Subjects
Year:
2023
Source:The Lancet Neurology