Treatment Perspectives

“I was impressed to see data for adult patients with anti-AChR Ab+ and anti-MuSK Ab+ gMG. I encourage you to review the results from the MycarinG clinical trial.

Beth Stein, MD*

Chief of Neurology

“I was impressed to see data for adult patients with anti-AChR Ab+ and anti-MuSK Ab+ gMG. I encourage you to review the results from the MycarinG clinical trial.

Explore the safety and efficacy data for RYSTIGGO in adult patients with anti-AChR Ab+ and anti-MuSK Ab+ gMG.

*Dr Beth Stein is a paid consultant of UCB, Inc.

Efficacy and Safety

Explore pivotal study results for RYSTIGGO here

Dosing

Learn about treatment-free
intervals and more for
RYSTIGGO

RYSTIGGO Access by State

See access data for your state

Resources

Consider these RYSTIGGO
resources for your practices

I was impressed to see data for adult patients with anti-AChR Ab+ and anti-MuSK Ab+ gMG. I encourage you to review the results from the MycarinG clinical trial.

Dr Beth Stein is a paid consultant of UCB, Inc.

Beth Stein, MD*

Chief of Neurology

St. Joseph’s Health

Clifton, New Jersey

RYSTIGGO is the first FDA-approved targeted treatment for both anti-AChR Ab+ and anti-MuSK Ab+ adult patients with gMG.¹

STUDY DESIGN

RYSTIGGO was studied in MycarinG, a large Phase 3 clinical trial of 200 adults with anti-AChR Ab+ and anti-MuSK Ab+ gMG^1,2

The efficacy and safety of RYSTIGGO for the treatment of gMG were established in an 18-week, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. In the study, 200 adults with gMG at least 18 years of age were randomized 1:1:1 to receive weight-tiered doses of RYSTIGGO (n=133), either 7 mg/kg of RYSTIGGO (n=66) or 10 mg/kg of RYSTIGGO (n=67), or placebo (n=67). All patients continued on current therapies.^1,2

MycarinG clinical trial^1,2

Chart representing MycarinG clinical trial results for RYSTIGGO

The clinical study included adult patients who were anti-AChR Ab+ and anti-MuSK Ab+, and who had MGFA Class II-IVa disease, an MG-ADL score of ≥3 (with ≥3 points from non-ocular symptoms), serum IgG levels of ≥5.5 g/L, a QMG score of at least 11, and who were on a stable dose of MG therapy prior to screening.^1,2

Baseline Characteristics^2,3:

	RYSTIGGO 7 mg/kg (n=66)	RYSTIGGO 10 mg/kg (n=67)	Placebo (n=67)
Mean age in years	53	52	50
Median duration of disease in years	5.3	5.7	6.8
Gender distribution, % female	59%	52%	70%
Race, % White	62%	73%	69%
Race, % Asian	14%	10%	7%
Race, % Black	0%	6%	1%
Race, % American Indian or Alaska Native	0%	0%	0%
Ethnicity, % Hispanic or Latino	8%	5%	8%
Mean MG-ADL total score	8.4	8.1	8.4
Mean QMG total score	15.4	15.6	15.8
Anti-AChR Ab+, n (%)	60 (91%)*	60 (90%)	59 (88%)*
Anti-MuSK Ab+, n (%)	5 (8%)	8 (12%)^†	8 (12%)^†
Treatment with acetylcholinesterase inhibitors, n (%)	55 (83%)	57 (85%)	60 (90%)
Treatment with steroids, n (%)	43 (65%)	48 (72%)	38 (57%)
Treatment with non-steroidal immunosuppressive therapies, n (%)	32 (48%)	38 (57%)	33 (49%)

*Includes 1 patient who had unknown AChR and MuSK autoantibody status.²

^†Includes 1 patient who had positive AChR and MuSK autoantibody status.²

EXTENSION STUDIES

The long-term safety and efficacy of RYSTIGGO were evaluated in adults in two extension studies^2,4,5

Patients from MycarinG could enroll in two extension studies, MG0004 and MG0007, that further evaluated the safety and efficacy of RYSTIGGO over time.^2,4,5

MG0004 (NCT04124965)

MG0004 was a 60-week, multicenter, randomized, Phase 3 extension study. 71 adult patients from MycarinG who met eligibility criteria were randomized to receive either RYSTIGGO 7 mg/kg or 10 mg/kg. Patients received RYSTIGGO once weekly for a period of up to 52 weeks, followed by 8 weeks of observation. MG0004 enrollment was closed upon the initiation of study MG0007.^3,5

MG0007 (NCT04650854)

MG0007 was a multicenter Phase 3 study that included 165 adults from MycarinG and MG0004. It assessed the long-term safety, tolerability, and efficacy of RYSTIGGO given in repeated 6-week cycles, based on the manifestation of gMG symptoms.^3,4

Chart representing long-term safety and efficacy extension studies

EFFICACY

Primary Endpoint: Change from baseline to Week 6 (Day 43) in MG-ADL total score in adults who are anti-AChR Ab+ or anti-MuSK Ab+^1-3*

Chart representing MG-ADL score improvement at Week 6

The efficacy of RYSTIGGO in adults who are anti-AChR Ab+ or anti-MuSK Ab+ was established in a multicenter, randomized, double-blind, placebo-controlled study. The study included a 4-week screening period and a 6-week treatment period followed by 8 weeks of observation.¹

During the treatment period, RYSTIGGO or placebo was administered subcutaneously once a week for 6 weeks.¹

Treatment initiation on Day 1.²

Clinically meaningful was established as a ≥2.0-point improvement in MG-ADL total score.²

The most common adverse reactions (≥10%) in adults treated with RYSTIGGO were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.¹

Proportion of MG-ADL responders from baseline at Week 6 (Day 43)²

Exploratory secondary endpoint: MG-ADL Responder Rate:

Adults with a ≥2.0-point improvement in MG-ADL total score from baseline at Week 6 (Day 43)²

Chart representing MG-ADL responder rate at Week 6

Study limitations: Responder rate was a prespecified secondary endpoint not controlled for multiplicity; therefore, data should be interpreted with caution and conclusions cannot be drawn.

QMG and MGC responders were established as adults with a ≥3.0-point improvement in QMG and MGC score from baseline at Week 6 (Day 43).²

QMG responder rates from baseline at Week 6 (Day 43) were 55% (n=35/64) in the RYSTIGGO 7 mg/kg group and 73% (n=45/62) in the RYSTIGGO 10 mg/kg group compared to 39% (n=25/64) in the placebo group. MGC responder rates from baseline at Week 6 (Day 43) were 61% (n=39/64) in the RYSTIGGO 7 mg/kg group and 74% (n=46/62) in the RYSTIGGO 10 mg/kg group compared to 41% (n=26/64) in the placebo group.²

The first treatment indicated for adults with anti-MuSK Ab+ gMG¹

Subgroup analysis of the primary efficacy endpoint:

Mean change from baseline to Week 6 (Day 43) in MG-ADL total score in adults with anti–MuSK Ab+ gMG^2,6

Chart representing change in MG-ADL in anti-MuSK gMG

All subgroup analyses were descriptive.

All adults with anti-MuSK Ab+ gMG who received RYSTIGGO and had data available at Week 6 (Day 43) were MG-ADL responders²

Subgroup analysis of MG-ADL responder rate:

Adults with anti-MuSK Ab+ gMG with a ≥2.0-point improvement in MG-ADL total score from baseline at Week 6 (Day 43)²

Chart representing MG-ADL response in anti-MuSK gMG

All subgroup analyses were descriptive.

Clinical responders were established as adults with a ≥2.0-point improvement in the total MG-ADL score compared to baseline at Week 6 (Day 43). Clinical responder data were not collected for 1 patient in the RYSTIGGO 10 mg/kg group who discontinued treatment.^2,3

QMG and MGC responders were established as adults with a ≥3.0-point improvement in QMG and MGC score from baseline at Week 6 (Day 43).¹³

QMG responder rates from baseline at Week 6 (Day 43) were 100% (n=5/5) in the RYSTIGGO 7 mg/kg group and 86% (n=6/7) in the RYSTIGGO 10 mg/kg group compared to 29% (n=2/7) in the placebo group. MGC responder rates from baseline at Week 6 (Day 43) were 100% (n=5/5) in the RYSTIGGO 7 mg/kg group and 100% (n=7/7) in the RYSTIGGO 10 mg/kg group compared to 0% (n=0/7) in the placebo group.¹³

OTHER MG-ADL EFFICACY ENDPOINT

Minimal Symptom Expression (MSE) rates observed during the pivotal study²

Other efficacy endpoint: Proportion of adults achieving MSE during treatment and observation in the pivotal study²

Chart representing MSE rates during pivotal study

All subgroup analyses were descriptive.

MSE was an exploratory endpoint and not controlled for multiplicity. Therefore, data should be interpreted with caution and conclusions cannot be drawn.

MG-ADL SCORES IN EXTENSION STUDIES

Improvements were observed in adults receiving subsequent cycles of RYSTIGGO³

Improvements in MG-ADL score across each subsequent 6-week treatment cycle³

Chart representing MG-ADL scores in extension studies

The most common adverse reactions being observed with repeated cyclic treatment were consistent with adverse reactions observed in the pivotal study^1,3

Interim analysis as of July 8, 2022.³

Treatment initiation on Day 1.³

The RYSTIGGO extension studies were open-label and not placebo-controlled; therefore, the efficacy and clinical significance of the results should be interpreted with caution.

MINIMAL SYMPTOM EXPRESSION (MSE) IN EXTENSION STUDIES

MSE rates through 6 subsequent cycles of RYSTIGGO³

Exploratory endpoint: Proportion of adults achieving MSE with each subsequent cycle of RYSTIGGO³

Chart representing MSE rates over 6 cycles of RYSTIGGO

Interim analysis as of July 8, 2022.

Day 43.

MSE was an exploratory endpoint and not controlled for multiplicity. Therefore, data should be interpreted with caution and conclusions cannot be drawn.

Data should be interpreted with caution given the decreasing number of patients receiving subsequent treatment cycles.

Data were pooled across MycarinG, the first 6 weeks of MG0004, and MG0007.

TREATMENT-FREE INTERVALS

In the extension studies, the majority of adults had treatment-free intervals between 4 and 8 weeks³

Time to subsequent symptom-driven treatment cycle from last subcutaneous infusion

Chart representing treatment-free intervals in extension studies

Interim analysis as of July 8, 2022.³

The median time between treatment cycles was 8 weeks (56 days) for adults treated with RYSTIGGO who initiated 4 cycles¹*
The safety of initiating subsequent cycles sooner than 9 weeks (63 days) from the start of the previous treatment cycle has not been established¹
The most common adverse reactions being observed with repeated cyclic treatment were consistent with adverse reactions observed in the pivotal study^1,5

This is equivalent to 14 weeks (98 days) from the start of the previous treatment cycle.¹

The RYSTIGGO extension studies were open-label and not placebo-controlled; therefore, the efficacy and clinical significance of the results should be interpreted with caution.

SAFETY

MycarinG CLINICAL TRIAL

RYSTIGGO safety was demonstrated in MycarinG, a Phase 3 clinical study^1,2

**Adverse reactions occurring in ≥5% of adults treated with RYSTIGGO and more frequently than in adults who received placebo¹**
Adverse Reaction	RYSTIGGO (n=133)	Placebo (n=67)
Headache	44%	19%
Any infection	23%	19%
Upper respiratory tract infection	8%	6%
Diarrhea	20%	13%
Pyrexia	17%	2%
Hypersensitivity reactions	11%	5%
Nausea	10%	8%
Administration site reactions	8%	3%
Abdominal pain	8%	6%
Arthralgia	7%	3%

The most common adverse reactions (≥10%) in adults treated with RYSTIGGO were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.¹

RYSTIGGO Warnings and Precautions

RYSTIGGO may increase the risk of infection¹*

Infections¹

In MycarinG and the extension studies, out of 196 patients treated with RYSTIGGO,
94 (48%) patients reported infection

Common infections (at least 5% frequency) were upper respiratory tract infections (17%), COVID-19 (14%), urinary tract infections (9%), and herpes simplex (6%)

Serious infections were reported in 4% of patients treated with RYSTIGGO

Three fatal cases of pneumonia were identified caused by COVID-19 infection in two patients and an unknown pathogen in one patient

Six cases of infections led to discontinuation of RYSTIGGO

Delay administration of RYSTIGGO to patients with an active infection¹

Monitor for signs and symptoms of infection in patients treated with RYSTIGGO¹

If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved¹

Immunization with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO.¹

Aseptic meningitis has been reported in patients treated with RYSTIGGO¹

Aseptic meningitis¹

Serious adverse reactions of aseptic meningitis (also called drug-induced aseptic meningitis) have been reported in patients treated with RYSTIGGO. If symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care.

Hypersensitivity reactions were observed in patients treated with RYSTIGGO¹

Hypersensitivity reactions¹

In clinical trials, hypersensitivity reactions, including angioedema and rash, occurred within 1 day to 2 weeks of administration

One patient discontinued RYSTIGGO due to a hypersensitivity reaction

Local reactions at the administration site occurred within 1 to 3 days after the most recent RYSTIGGO infusion

Monitor patients during administration and for 15 minutes after completion for clinical signs and
symptoms of hypersensitivity reactions¹

If a hypersensitivity reaction occurs during administration, the healthcare professional should
institute appropriate measures if needed or the patient should seek medical attention¹

EXTENSION STUDIES

RYSTIGGO safety was further evaluated in the extension studies, with primary endpoints assessing the proportion of patients experiencing TEAEs^4,5

TEAEs reported in >10% of adults in at least one of the RYSTIGGO treatment groups³

Chart representing TEAEs in RYSTIGGO extension safety studies

Ab+=antibody positive; AChE=acetylcholinesterase; AChR=acetylcholine receptor; COVID-19=coronavirus disease 2019; 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; R=randomization; SQ=subcutaneous; TEAEs=treatment-emergent adverse events.

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.
A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis. ClinicalTrials.gov identifier: NCT04650854. Updated February 26, 2024. Accessed June 6, 2024. https://clinicaltrials.gov/study/NCT04650854
A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis. ClinicalTrials.gov identifier: NCT04124965. Updated September 5, 2023. Accessed June 6, 2024. https://clinicaltrials.gov/study/NCT04124965
Habib A, Kaminski H, Drużdż A, et al. Efficacy of rozanolixizumab in muscle specific kinase antibody-positive generalized myasthenia gravis: outcomes from the randomized, phase 3 MycarinG study. Paper presented at: AANEM 2022; September 21-24, 2022; Nashville, TN.

As a clinician, I appreciate that RYSTIGGO treatment cycles can be individualized based on clinical evaluation of adult patients. In the RYSTIGGO clinical trials, 8 weeks of observation followed the 6-week treatment period, and 4 treatment cycles were administered each year on average.

Dr Beth Stein is a paid consultant of UCB, Inc.

Beth Stein, MD*

Chief of Neurology

St. Joseph’s Health

Clifton, New Jersey

RYSTIGGO DOSING AND ADMINISTRATION

RYSTIGGO is a once-weekly subcutaneous infusion administered in approximately 15 minutes once preparation is complete¹

Administration:

Time of administration may vary by patient. Duration of infusion may be longer based on flow rate and patient weight¹
RYSTIGGO is intended to be infused in the lower right or lower left part of the abdomen below the navel¹
Do not infuse where the skin is tender, bruised, red, or hard. Avoid infusing into tattoos, scars, or stretch marks¹
Rotate infusion sites for subsequent administrations¹

Observation:

Monitor patients during treatment with RYSTIGGO and for 15 minutes after completion for clinical signs and symptoms of hypersensitivity reactions. If a reaction occurs, discontinue administration of RYSTIGGO and institute appropriate measures if needed¹
In clinical trials, hypersensitivity reactions occurred within 1 day to 2 weeks of administration. One patient discontinued RYSTIGGO due to a hypersensitivity reaction. Local reactions at the administration site occurred within 1 to 3 days after the most recent RYSTIGGO infusion¹

RYSTIGGO is given once-weekly by a healthcare professional in 6-week cycles, followed by an individualized treatment break¹*^†

RYSTIGGO is intended for subcutaneous administration using an infusion pump at a constant flow rate of up to 20 mL/hr.¹

If a scheduled infustion is missed, RYSTIGGO may be administered up to 4 days after the scheduled time point. Thereafter, resume the original dosing schedule until the treatment cycle is completed.¹

In RYSTIGGO clinical studies¹:

8 weeks of observation followed the 6-week treatment period

The safety of initiating subsequent cycles sooner than 9 weeks (63 days) from the start of the previous treatment cycle has not been established

4 treatment cycles were initiated per year, on average (range: 1-7 cycles)

RYSTIGGO dosage is based on body weight¹

Body weight of patient	Dose	Vial strength	Dosage volume
<50 kg	420 mg	420 mg/3 mL (140 mg/mL)	3 mL
50 to <100 kg	560 mg	560 mg/4 mL (140 mg/mL)	4 mL
≥100 kg	840 mg	840 mg/6 mL (140 mg/mL)	6 mL

Body weight of patient
<50 kg	50 to <100 kg	≥100 kg
Dose
420 mg	560 mg	840 mg
Vial strength
420 mg/3 mL (140 mg/mL)	560 mg/4 mL (140 mg/mL)	840 mg/6 mL (140 mg/mL)
Dosage volume
3 mL	4 mL	6 mL

RYSTIGGO is administered as a subcutaneous infusion once weekly for 6 weeks¹

If a scheduled infusion is missed, RYSTIGGO may be administered up to 4 days after the scheduled time point¹
Thereafter, resume the original dosing schedule until the treatment cycle is completed¹

Consider the need for future cycles when prescribing RYSTIGGO.

RYSTIGGO infusions can be administered in different settings

RYSTIGGO is for subcutaneous administration only using an infusion pump. Refer to the infusion pump manufacturer’s instructions for full preparation and administration information. It is recommended to use pumps where administered volume can be preset, as each vial contains excess volume for priming of the infusion line.¹

Physician office infusion suite

These physician offices have capabilities to both prescribe and infuse RYSTIGGO.

Independent infusion center

These centers are independent from physician offices and hospitals. Infusion nurses staff these centers; physicians may or may not be on site.

Home infusion

Some patients may be eligible for RYSTIGGO to be administered at home by a trained nurse. Eligibility is based on a patient’s insurance plan. Not all patients are eligible.

Hospital outpatient department

These facilities exist within hospitals for patients who do not need to be admitted to receive infusions.

Administration considerations with RYSTIGGO¹

Infections

Delay RYSTIGGO administration in patients with an active infection until the infection is resolved. During treatment with RYSTIGGO, monitor for clinical signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved.

Immunization

Because RYSTIGGO causes a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO.

Hypersensitivity Reactions

Angioedema and rash have occurred in patients treated with RYSTIGGO. Monitor patients during treatment with RYSTIGGO and for 15 minutes after the administration is complete for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.

Effect of RYSTIGGO on other drugs

Concomitant use of RYSTIGGO with medications that bind to the human neonatal Fc receptor (FcRn) (eg, immunoglobulin products, monoclonal antibodies, or antibody derivatives containing the human Fc domain of the IgG subclass) may lower systemic exposures and reduce effectiveness of such medications.

gMG=generalized myasthenia gravis.

Reference:

RYSTIGGO [Prescribing Information]. Smyrna, GA: UCB, Inc.

“As a clinician, I appreciate that RYSTIGGO treatment cycles can be individualized based on clinical evaluation of adult patients. In the RYSTIGGO clinical trials, 8 weeks of observation followed the 6-week treatment period, and 4 treatment cycles were administered each year on average.

“As a clinician, I appreciate that RYSTIGGO treatment cycles can be individualized based on clinical evaluation...”

Explore time between treatment cycles, weight-based dosing, and more for RYSTIGGO.

Dr Beth Stein is a paid consultant of UCB, Inc.

Beth Stein, MD*

Chief of Neurology

St. Joseph’s Health

Clifton, New Jersey

PracticeShare^® by Treatment Perspectives^®

RYSTIGGO Infusion Centers in New Jersey^*

In New Jersey, there are up to 12 of infusion centers^† that provide infusion therapies like RYSTIGGO. Find an infusion center: https://www.rystiggo.com/infusion-finder¹

For consideration: Sites listed in the Infusion Site Finder represent sites of care that opted in for inclusion in the tool. Site of care management by individual health plans may limit options beyond what appears in the tool.

As of February 27, 2025. For current infusion center locations, visit https://www.rystiggo.com/infusion-finder

RYSTIGGO access for adult patients in New Jersey²

Traditional Medicare

100% of patients have open access to RYSTIGGO
No prior authorization or prior use specifications required
Patients with a supplemental or Medigap plan pay out $0 out of pocket^‡

Medicare Advantage

99% of patients have a defined access pathway to RYSTIGGO¹
Prior authorization requirements are aligned to prescribing information and the Phase 3 trial design

Commercial

100% of patients have a defined access pathway to RYSTIGGO^1§
Patients may pay as little as $0 out of pocket with the RYSTIGGO Patient Savings Program^¶

80% of Traditional Medicare patients have a supplemental or Medigap plan.

Coverage for RYSTIGGO will depend on the terms and conditions of your patient’s insurance plan.

Full eligibility terms and conditions apply.

References: 1. UCB Data on file. 2. MMIT as of 01/27/2025.

PracticeShare^® by Treatment Perspectives^®

RYSTIGGO Infusion
Centers in New Jersey*

In New Jersey, there are up to 12 of infusion centers^† that provide infusion therapies like RYSTIGGO. Find an infusion center: https://www.rystiggo.com/infusion-finder¹

I encourage you to check out ONWARD^®. I have found it to be a very helpful tool for my adult patients with anti-AChR or anti-MuSK Ab+ gMG starting RYSTIGGO. It’s important that my patients feel confident and supported throughout their treatment.

Dr Beth Stein is a paid consultant of UCB, Inc.

Beth Stein, MD*

Chief of Neurology

St. Joseph’s Health

Clifton, New Jersey

Accessing RYSTIGGO

Helpful resources on accessing RYSTIGGO for your adult patients

Tools to Support You and Your Practice

How to Acquire RYSTIGGO

Fact sheet with contact information for authorized specialty distributors or pharmacies to help acquire RYSTIGGO

Coding and Billing Guide (J-Code: J9333)

Reference guide with important codes, sample claim forms, and coding and billing information for RYSTIGGO

Fulfillment Resource Guide

Detailed information on acquiring RYSTIGGO, navigating the reimbursement process, referring to alternate sites of care, and engaging patient support services

Prior Authorization/Predetermination Checklist

Checklist for those health plans that require a prior authorization before patients can get started on RYSTIGGO

Guide to Writing a Letter of Appeal

Guide on how to write a letter of appeal if a health plan has denied a prior authorization request for RYSTIGGO

Guide to Writing a Letter of Medical Necessity

Guide on how to write a letter of medical necessity to support coverage of RYSTIGGO for those health plans that require this information

Understanding RYSTIGGO

Helpful resources for understanding more about RYSTIGGO

Product Information

Your guide to RYSTIGGO, including product specifications, storage and handling, recommended equipment, and dosage and administration

Dosing and Administration Guide

Detailed information on the once-weekly dosing and administration of RYSTIGGO for adults with gMG

Visual Administration Guide

Your quick reference guide on preparing and performing infusion with RYSTIGGO

Patient Resources

Helpful resources to provide to your adult patients about RYSTIGGO

RYSTIGGO Patient Brochure

A detailed brochure to help your patients better understand treatment with RYSTIGGO

ONWARD Brochure

Personalized support for patients to help start and continue treatment with RYSTIGGO, track symptoms, and view options for financial assistance

MG-ADL Guide

A helpful tool your patients can use to measure gMG symptoms and share that information with you

Video Resources

Engaging videos to learn more about RYSTIGGO

RYSTIGGO Pivotal Study: MG-ADL Results

Watch a video featuring Dr. Christyn Edmundson, an expert in gMG, discussing the MG-ADL results from the RYSTIGGO pivotal study

RYSTIGGO Pivotal Study: Secondary Endpoint Results Including MG Symptoms PRO

Video features Dr. Christyn Edmundson, an expert in gMG, discussing the secondary endpoint results, including MG Symptoms PRO, from the RYSTIGGO pivotal study

RYSTIGGO Extension Studies

See a video that features Dr. Christyn Edmundson, an expert in gMG, discussing the RYSTIGGO extension studies that further evaluated the safety and efficacy of RYSTIGGO over time

RYSTIGGO Mechanism of Action Video

RYSTIGGO specifically targets and blocks IgG antibodies from binding to FcRn. See how blocking FcRn removes AChR and MuSK autoantibodies^1,2*

The precise mechanism through which RYSTIGGO exerts therapeutic effects in gMG is unknown.

RYSTIGGO Administration Video

Watch step-by-step instructions on the proper administration of RYSTIGGO

ONWARD provides patient support for RYSTIGGO patients

AChR=acetylcholine receptor; FcRn=neonatal Fc receptor; gMG=generalized myasthenia gravis; IgG=immunoglobulin G; MG-ADL=Myasthenia Gravis Activities of Daily Living; MG Symptoms PRO/MGSPRO=Myasthenia Gravis Symptoms Patient-Reported Outcome; MuSK=muscle-specific tyrosine kinase.

References:

RYSTIGGO [Prescribing Information]. Smyrna, GA: UCB, Inc.
Lledo-Garcia R, Dixon K, Shock A, Oliver R. Pharmacokinetic-pharmacodynamic modelling of the anti-FcRn monoclonal antibody rozanolixizumab: translation from preclinical stages to the clinic. CPT Pharmacometrics Syst Pharmacol. 2022;11(1):116-128. doi:10.1002/psp4.12739

“I encourage you to check out ONWARD^®. I have found it to be a very helpful tool for my adult patients with anti-AChR or anti-MuSK Ab+ gMG starting RYSTIGGO. It’s important that my patients feel confident and supported throughout their treatment.

“I encourage you to check out ONWARD^®. I have found it to be a very helpful tool for my adult patients...”

Explore the extensive resources available for RYSTIGGO.

Dr Beth Stein is a paid consultant of UCB, Inc.

Beth Stein, MD*

Chief of Neurology

St. Joseph’s Health

Clifton, New Jersey

I was impressed to see data for adult patients with anti-AChR Ab+ and anti-MuSK Ab+ gMG. I encourage you to review the results from the MycarinG clinical trial.

I was impressed to see data for adult patients with anti-AChR Ab+ and anti-MuSK Ab+ gMG. I encourage you to review the results from the MycarinG clinical trial.

STUDY DESIGN

RYSTIGGO was studied in MycarinG, a large Phase 3 clinical trial of 200 adults with anti-AChR Ab+ and anti-MuSK Ab+ gMG1,2

The long-term safety and efficacy of RYSTIGGO were evaluated in adults in two extension studies2,4,5

EFFICACY

Primary Endpoint: Change from baseline to Week 6 (Day 43) in MG-ADL total score in adults who are anti-AChR Ab+ or anti-MuSK Ab+1-3*

Proportion of MG-ADL responders from baseline at Week 6 (Day 43)2

The first treatment indicated for adults with anti-MuSK Ab+ gMG1

All adults with anti-MuSK Ab+ gMG who received RYSTIGGO and had data available at Week 6 (Day 43) were MG-ADL responders2

Minimal Symptom Expression (MSE) rates observed during the pivotal study2

Improvements were observed in adults receiving subsequent cycles of RYSTIGGO3

MSE rates through 6 subsequent cycles of RYSTIGGO3

In the extension studies, the majority of adults had treatment-free intervals between 4 and 8 weeks3

SAFETY

RYSTIGGO safety was demonstrated in MycarinG, a Phase 3 clinical study1,2

RYSTIGGO Warnings and Precautions

RYSTIGGO safety was further evaluated in the extension studies, with primary endpoints assessing the proportion of patients experiencing TEAEs4,5

As a clinician, I appreciate that RYSTIGGO treatment cycles can be individualized based on clinical evaluation of adult patients. In the RYSTIGGO clinical trials, 8 weeks of observation followed the 6-week treatment period, and 4 treatment cycles were administered each year on average.

As a clinician, I appreciate that RYSTIGGO treatment cycles can be individualized based on clinical evaluation of adult patients. In the RYSTIGGO clinical trials, 8 weeks of observation followed the 6-week treatment period, and 4 treatment cycles were administered each year on average.

RYSTIGGO DOSING AND ADMINISTRATION

RYSTIGGO is a once-weekly subcutaneous infusion administered in approximately 15 minutes once preparation is complete1

RYSTIGGO is given once-weekly by a healthcare professional in 6-week cycles, followed by an individualized treatment break1*†

RYSTIGGO dosage is based on body weight1

RYSTIGGO infusions can be administered in different settings

Administration considerations with RYSTIGGO1

RYSTIGGO access for adult patients in New Jersey2

Traditional Medicare

Medicare Advantage

Commercial

I encourage you to check out ONWARD®. I have found it to be a very helpful tool for my adult patients with anti-AChR or anti-MuSK Ab+ gMG starting RYSTIGGO. It’s important that my patients feel confident and supported throughout their treatment.

I encourage you to check out ONWARD®. I have found it to be a very helpful tool for my adult patients with anti-AChR or anti-MuSK Ab+ gMG starting RYSTIGGO. It’s important that my patients feel confident and supported throughout their treatment.

Accessing RYSTIGGO

Helpful resources on accessing RYSTIGGO for your adult patients

Understanding RYSTIGGO

Helpful resources for understanding more about RYSTIGGO

Patient Resources

Helpful resources to provide to your adult patients about RYSTIGGO

Video Resources

Engaging videos to learn more about RYSTIGGO

ONWARD provides patient support for RYSTIGGO patients

IMPORTANT SAFETY INFORMATION

RYSTIGGO was studied in MycarinG, a large Phase 3 clinical trial of 200 adults with anti-AChR Ab+ and anti-MuSK Ab+ gMG^1,2

The long-term safety and efficacy of RYSTIGGO were evaluated in adults in two extension studies^2,4,5

Primary Endpoint: Change from baseline to Week 6 (Day 43) in MG-ADL total score in adults who are anti-AChR Ab+ or anti-MuSK Ab+^1-3*

Proportion of MG-ADL responders from baseline at Week 6 (Day 43)²

The first treatment indicated for adults with anti-MuSK Ab+ gMG¹

All adults with anti-MuSK Ab+ gMG who received RYSTIGGO and had data available at Week 6 (Day 43) were MG-ADL responders²

Minimal Symptom Expression (MSE) rates observed during the pivotal study²

Improvements were observed in adults receiving subsequent cycles of RYSTIGGO³

MSE rates through 6 subsequent cycles of RYSTIGGO³

In the extension studies, the majority of adults had treatment-free intervals between 4 and 8 weeks³

RYSTIGGO safety was demonstrated in MycarinG, a Phase 3 clinical study^1,2

RYSTIGGO safety was further evaluated in the extension studies, with primary endpoints assessing the proportion of patients experiencing TEAEs^4,5

RYSTIGGO is a once-weekly subcutaneous infusion administered in approximately 15 minutes once preparation is complete¹

RYSTIGGO is given once-weekly by a healthcare professional in 6-week cycles, followed by an individualized treatment break¹*^†

RYSTIGGO dosage is based on body weight¹

Administration considerations with RYSTIGGO¹

RYSTIGGO access for adult patients in New Jersey²

I encourage you to check out ONWARD^®. I have found it to be a very helpful tool for my adult patients with anti-AChR or anti-MuSK Ab+ gMG starting RYSTIGGO. It’s important that my patients feel confident and supported throughout their treatment.

I encourage you to check out ONWARD^®. I have found it to be a very helpful tool for my adult patients with anti-AChR or anti-MuSK Ab+ gMG starting RYSTIGGO. It’s important that my patients feel confident and supported throughout their treatment.