SAFETY
Examine safety profiles from RAISE and RAISE-XT
RAISE: safety and tolerability were demonstrated in a Phase 3 pivotal study1,2
Adverse reactions in ≥5% of patients treated with ZILBRYSQ and more frequently than in patients who received placebo.1
%
%
The most common adverse reactions (reported in at least 10% of patients treated with ZILBRYSQ) were injection site reactions, upper respiratory tract infections, and diarrhea.1
Immunize patients with meningococcal vaccines at least 2 weeks before administering the first dose of ZILBRYSQ.1
RAISE-XT primary endpoint: safety and tolerability3,4
ZILBRYSQ was generally well-tolerated with most TEAEs mild to moderate in severity at a median exposure of 2.2 years (range: 0.1-5.6 years)4
- TEAEs seen in the RAISE-XT study were similar to those seen in the RAISE study. No new safety concerns were raised3
- 10.5% of patients (n=21) discontinued ZILBRYSQ by Week E108 due to TEAEs4
In RAISE-XT, morphea was observed in 10 (5%) patients; most cases had a time to onset longer than one year after start of treatment and were mild to moderate in severity. One patient discontinued ZILBRYSQ due to morphea.1
Most common treatment-emergent adverse events (TEAEs)4
(N=200)
Includes all deaths.
No deaths were considered treatment related. TEAEs leading to death included cardiac arrest (n=2), accidental head injury (n=1), and death from an unknown cause (n=1).
Only most-common TEAEs, occurring in ≥15% of patients overall, are reported.
Data cutoff: 11 November 2023.
COVID-19=coronavirus disease 2019; IMP=investigational medicinal product; TEAE=treatment-emergent adverse event; URTI=upper respiratory tract infection; UTI=urinary tract infection.
Additional ZILBRYSQ warnings and precautions1
Other infections
Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported in patients treated with complement inhibitors.
ZILBRYSQ blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections caused by Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae.
Administer vaccinations for the prevention of Streptococcus pneumoniae infection according to ACIP recommendations. Patients receiving ZILBRYSQ are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.
Pancreatitis and other pancreatic conditions
Pancreatitis and pancreatic cysts have been reported in patients treated with ZILBRYSQ.
RAISE-XT
n (%)
During the open-label extension studies, 7 (3.3%) patients experienced pancreatic events, including 4 (1.9%) patients with pancreatitis and 3 (1.4%) with pancreatic cysts.
Patients should be informed of the risk of pancreatitis and other pancreatic conditions before starting ZILBRYSQ.
Discontinue ZILBRYSQ in patients with suspected pancreatitis and initiate appropriate management until pancreatitis is ruled out or has resolved.
RAISE
n (%)
n (%)
In the 3-month, double-blind Study 1, adverse reactions of increased lipase were reported in 6 (6.9%) patients treated with ZILBRYSQ compared to no patients on placebo, and adverse reactions of increased amylase were reported in 4 (4.7%) patients treated with ZILBRYSQ compared to 1 (1.1%) patient on placebo. Lipase levels exceeded three times the upper limit of normal in 6 (7%) patients after being started on ZILBRYSQ compared to no patients on placebo.
Obtain lipase and amylase levels at baseline before starting treatment with ZILBRYSQ.
References:
- ZILBRYSQ [Prescribing Information]. Smyrna, GA: UCB, Inc.
- Vu T, Genge A, Hussain Y, et al; on behalf of the RAISE Investigators. Efficacy and safety of zilucoplan in myasthenia gravis: responder analysis from the randomized Phase 3 RAISE trial. Poster presented at: American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting; September 21-24, 2022; Nashville, TN. Poster 200.
- Howard JF Jr, Bresch S, Farmakidis C, et al. Long-term safety and efficacy of zilucoplan in patients with generalized myasthenia gravis: interim analysis of the RAISE-XT open-label extension study. Ther Adv Neurol Disord. 2024;17(3):1-16. doi:10.1177/17562864241243186
- Howard JF Jr, Freimer M, Genge A, et al. Response rates with zilucoplan in generalised myasthenia gravis: 120-week interim analysis of RAISE-XT. Presented at: International Congress on Neuromuscular Diseases; October 25-29, 2024; Perth, Australia. Session OS.03.06.
