ZILBRYSQ delivered statistically significant, clinically meaningful improvements across all primary and key secondary efficacy endpoints at Week 12 (Myasthenia Gravis Activities of Daily Living [MG-ADL], Quantitative Myasthenia Gravis [QMG], Myasthenia Gravis Composite [MGC], and Myasthenia Gravis Quality of Life 15-item revised [MG-QoL 15r]) compared to placebo.¹*

The treatment effect in the ZILBRYSQ group for all four endpoints was observed as early as Week 1.¹

Results may vary.

Clinically meaningful was defined as a ≥2-point change in MG-ADL score, a ≥3-point change in QMG score, and as a 3-point change in MGC score. Clinical meaningfulness threshold for MG-QoL 15r has not been established.²

See the clinical trial data.

Yes. The long-term safety and efficacy of ZILBRYSQ are being evaluated in the ongoing RAISE-XT extension trial. The primary endpoint of RAISE-XT evaluated the long-term safety and tolerability of ZILBRYSQ. Long-term efficacy was also studied through multiple measures as secondary endpoints.⁴

Study limitations: the open-label extension study was designed to evaluate safety and was not placebo controlled; therefore, efficacy or clinical significance should be interpreted with caution.

See the clinical trial data, including long-term data.

The efficacy of ZILBRYSQ for the treatment of adults with anti-AChR Ab+ gMG was established in a Phase 3, randomized, double-blind, placebo-controlled study (RAISE).³ 

RAISE-XT is an extension study of adult patients who opted to continue on ZILBRYSQ or switch to ZILBRYSQ from placebo.⁴

Study limitations: The open-label extension study was designed to evaluate safety and was not placebo controlled; therefore, efficacy or clinical significance should be interpreted with caution.

Explore the clinical trial data.

Efficacy was evaluated in terms of the primary endpoint: change from baseline (CFB) in Myasthenia Gravis Activities of Daily Living (MG-ADL) at Week 12.

Secondary endpoints include CFB in Quantitative Myasthenia Gravis (QMG) score, Myasthenia Gravis Composite (MGC) score, and MG Quality of Life (MG-QoL 15r) score.¹

Explore clinical trial data.

Yes. MSE was defined as an MG-ADL total score of 0-1 without rescue therapy. MSE was specified as an other secondary efficacy endpoint in the RAISE study and an exploratory endpoint in RAISE-XT. Results should be interpreted with caution.^1,4

See MSE through Week E108.

There is currently no data on the use of ZILBRYSQ with an FcRn.

ZILBRYSQ, a macrocyclic peptide, is a complement component 5 (C5) inhibitor that specifically targets the complement cascade.^1,3

Learn more about the ZILBRYSQ MOA.

Overviews of the Quantitative Myasthenia Gravis (QMG), Myasthenia Gravis Composite (MGC), Myasthenia Gravis Quality of Life 15-item revised (MG-QoL 15r) scale, can be found here.

See additional secondary endpoints in RAISE.

See additional secondary endpoints in RAISE-XT.

Yes. Dr. Michael Weiss, an expert in gMG, discusses the RAISE clinical studies with a focus on the primary endpoints of MG-ADL total score and long-term safety and tolerability in the video ZILBRYSQ: A Clinically Proven Choice.

Watch now.

Yes. All healthcare providers who want to prescribe ZILBRYSQ must be certified in the ZILBRYSQ REMS. Certification includes a review of REMS educational materials and enrollment into the ZILBRYSQ REMS, which can be found by visiting www.ZILBRYSQREMS.com.³

• Prescribers must counsel patients about the risk of serious meningococcal infection
• Prescribers must provide the patients with the REMS educational materials
• Prescribers must assess patient vaccination status for meningococcal vaccines (against serogroups A, C, W, Y, and B) and vaccinate if needed according to the full ZILBRYSQ Prescribing Information two weeks prior to the first dose of ZILBRYSQ
• Patients must be instructed to carry the Patient Safety Card with them at all times during and for 2 months following treatment discontinuation with ZILBRYSQ

Learn more about ZILBRYSQ REMS.

Yes. ZILBRYSQ is a complement component 5 (C5) inhibitor and according to current Advisory Committee on Immunization Practices (ACIP) recommendations for patients receiving a complement inhibitor, vaccinations are required.³

Patients must complete or update meningococcal vaccination (for serogroups A, C, W, Y, and B) at least 2 weeks prior to administration of the first dose of ZILBRYSQ.³

More information about vaccination requirements.

Yes. UCB is working with PANTHERx Rare as the ZILBRYSQ-exclusive dispensing pharmacy to help patients access their REMS-required vaccines, offering vaccination status and tracking and vaccination support.

Learn more about how PANTHERx Rare can help.

The safety and tolerability of ZILBRYSQ were demonstrated in the RAISE Phase 3 clinical study. 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.^1,3

See additional safety information.

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

ZILBRYSQ, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

• Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of ZILBRYSQ, unless the risks of delaying therapy outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccination against meningococcal bacteria in patients receiving a complement inhibitor.
• Patients receiving ZILBRYSQ are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.

Because of the risk of serious meningococcal infections, ZILBRYSQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ZILBRYSQ REMS.³

Additional important warnings and precautions associated with ZILBRYSQ include an increased susceptibility to infections and pancreatitis and pancreatic cysts.³

See additional safety information.

ZILBRYSQ is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection.³

See additional safety information.

No. ZILBRYSQ prefilled syringes come ready to use.³

ZILBRYSQ is available in 3 doses based on patients' weight³:

• 16.6 mg/0.416 mL—Less than 56 kg (<123 lbs)
• 23 mg/0.574 mL—56 kg to less than 77 kg (123–<170 lbs)
• 32.4 mg/0.81 mL—77 kg and above (≥170 lbs)

Learn more about dosing and administration.

No. ZILBRYSQ can be stored at room temperature in the original carton up to 3 months if refrigeration isn’t available.³

How ZILBRYSQ prefilled syringes may be stored at room temperature³:

• Remove from refrigerator and find a safe place to store ZILBRYSQ
• Write the date removed from the refrigerator in the space provided on the carton
• Store at room temperature up to 86°F (30°C) in the original carton for a single period of up to 3 months
• Discard if not used within 3 months, or if the expiration date has passed, whichever occurs first
• Do not return ZILBRYSQ to the refrigerator after it has been stored at room temperature

Watch a step-by-step demonstration of the proper self-administration of ZILBRYSQ.

The Self-Injection Assessment Questionnaire^© (SIAQ) was administered to patients who participated in RAISE-XT.⁵

89% (n=56) were satisfied or very satisfied with the time it took to self-administer ZILBRYSQ.

84% (n=53) were very or extremely confident in their ability to self-administer ZILBRYSQ.

Learn more about the SIAQ and patient satisfaction and compliance with ZILBRYSQ.

ONWARD^® is an individualized support experience built to help your eligible patients through every step of their ZILBRYSQ treatment.* 

With ONWARD, your prescribed patients living with generalized myasthenia gravis (gMG) will be paired with a dedicated, medically trained Care Coordinator who will provide tailored support based on each patient's unique needs.^†

ONWARD is provided as a service of UCB and is intended to support the appropriate use of UCB medicines. ONWARD may be amended or canceled at any time without notice. Some program and eligibility restrictions may apply.

ONWARD does not provide medical advice and does not replace the care of the healthcare provider. Care Coordinators will refer patients to their healthcare provider for any treatment-related questions.

Learn more about the resources offered via ONWARD.

Yes. To get a patient who has been prescribed ZILBRYSQ started in ONWARD, please follow these steps:

1. Enroll in ZILBRYSQ REMS at www.ZILBRYSQREMS.com. (Once enrolled, you do not need to re-enroll for subsequent patients.) 

2. Review the REMS safety information with your patient. 

3. Complete the ZILBRYSQ Start Form, providing all required information. 

4. Have your patient read and sign the Patient Authorization sections of the Start Form. 

5. Fax the completed Start Form to 1-833-FAX-UCB1 (1-833-329-8221) or email it to ucbonward@rxallcare.com.

Get your patients started.

Downloadable resources are available to help your patients access ZILBRYSQ. These resources include: ZILBRYSQ Start Guide, Guides to Writing a Letter of Medical Necessity and a Letter of Appeal, and a Prior Authorization/Predetermination Checklist.

Downloadable resources are available to help your patients start and stay on ZILBRYSQ, including the ZILBRYSQ Patient Brochure, ONWARD^® Brochure, ONWARD Start Form, MG-ADL Guide, Instructions for Use, and the IRA Medicare Brochure.