Study design
STUDY DESIGN
RYSTIGGO was
studied in the
Phase 3
MycarinG
clinical trial1,2
Anti-AChR Ab+ and anti-MuSK Ab+ gMG
patients were enrolled in MycarinG1
Change from baseline in MG‑ADL total score
at Week 6 (Day 43) was the primary endpoint1
Anti-AChR Ab+ and anti-MuSK Ab+ gMG
adult patients were enrolled in MycarinG1
Change from baseline in MG‑ADL
total score at Week 6 (Day 43) was the primary endpoint1
MycarinG CLINICAL TRIAL
Efficacy, safety, and tolerability were evaluated in a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of adult patients with mild to severe gMG1,2
This trial assessed 2 doses of RYSTIGGO, 7 mg/kg (n=66) and 10 mg/kg (n=67), vs placebo (n=67). All patients continued on current therapies.1,2
Inclusion Criteria1,2
Adult patients enrolled in the study met the following criteria:
- Presence of autoantibodies against AChR or MuSK
- MGFA Clinical Classification Class II to IVa
- MG-ADL total score of at least 3 (with ≥3 points from non-ocular symptoms)
- On stable dose of MG therapy prior to screening that included AChE inhibitors, steroids, or other NSISTs, either in combination or alone
- Serum IgG levels of at least 5.5 g/L
- QMG score of at least 11
Baseline characteristics2,3
*Includes one patient who had unknown AChR and MuSK autoantibody status.2
†Includes one patient who had positive AChR and MuSK autoantibody status.2
‡Patient was classified as MGFA class III at screening, but class IVb at baseline.2
Ab+=antibody positive; AChE=acetylcholinesterase; AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; IgG=immunoglobulin G; MG-ADL=Myasthenia Gravis Activities of Daily Living; MGFA=Myasthenia Gravis Foundation of America; MuSK=muscle-specific tyrosine kinase; NSISTs=non-steroidal immunosuppressive therapies; QMG=Quantitative Myasthenia Gravis.
References:
- RYSTIGGO [Prescribing Information]. Smyrna, GA: UCB, Inc.
- Bril V, Drużdż A, Grosskreutz J, et al. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023;22(5):383-394. doi:10.1016/S1474-4422(23)00077-7
- Data on file. UCB Inc., Smyrna, GA.