UCB showcases new data for gMG management at the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Session
UCB will present 14 abstracts at the 2024 AANEM Annual Meeting and MGFA Scientific Session, showcasing new data for its gMG treatments. Key highlights include:
- Long-term safety and efficacy data for ZILBRYSQ® (zilucoplan) and RYSTIGGO® (rozanolixizumab-noli)
- Results from the RAISE-XT trial for zilucoplan, including 120-week interim analysis
- Post hoc analyses from the Phase 3 MycarinG trial for rozanolixizumab
- Data on switching to subcutaneous zilucoplan from IV complement inhibitors
- Insights on corticosteroid sparing and changes in immunosuppressant therapy
The presentations emphasize UCB's leadership in neuromuscular research and commitment to advancing gMG treatment. UCB will also host an industry-sponsored session on gMG treatment choices.
UCB presenterà 14 abstract al 2024 AANEM Annual Meeting e alla sessione scientifica MGFA, mostrando nuovi dati sui suoi trattamenti per il gMG. I punti salienti includono:
- Dati di sicurezza ed efficacia a lungo termine per ZILBRYSQ® (zilucoplan) e RYSTIGGO® (rozanolixizumab-noli)
- Risultati dello studio RAISE-XT per zilucoplan, inclusa un'analisi intermedia a 120 settimane
- Analisi post hoc del trial di Fase 3 MycarinG per rozanolixizumab
- Dati sul passaggio da inibitori del complemento IV a zilucoplan sottocutaneo
- Approfondimenti sull'alleggerimento dell'uso di corticosteroidi e sui cambiamenti nella terapia immunosoppressiva
Le presentazioni sottolineano la leadership di UCB nella ricerca neuromuscolare e l'impegno a favore del progresso nel trattamento del gMG. UCB ospiterà anche una sessione sponsorizzata dall'industria sulle scelte di trattamento per il gMG.
UCB presentará 14 resúmenes en la Reunión Anual AANEM 2024 y en la Sesión Científica de MGFA, mostrando nuevos datos sobre sus tratamientos para gMG. Los aspectos más destacados incluyen:
- Datos de seguridad y eficacia a largo plazo para ZILBRYSQ® (zilucoplan) y RYSTIGGO® (rozanolixizumab-noli)
- Resultados del ensayo RAISE-XT para zilucoplan, incluida un análisis intermedio a 120 semanas
- Análisis post hoc del ensayo de Fase 3 MycarinG para rozanolixizumab
- Datos sobre el cambio a zilucoplan subcutáneo desde inhibidores del complemento IV
- Comentarios sobre la reducción del uso de corticosteroides y los cambios en la terapia inmunosupresora
Las presentaciones enfatizan el liderazgo de UCB en la investigación neuromuscular y su compromiso con el avance del tratamiento de gMG. UCB también llevará a cabo una sesión patrocinada por la industria sobre opciones de tratamiento para gMG.
UCB는 2024 AANEM 연례 회의 및 MGFA 과학 세션에서 총 14개의 초록을 발표하며, gMG 치료법에 대한 새로운 데이터를 선보입니다. 주요 하이라이트는 다음과 같습니다:
- ZILBRYSQ® (zilucoplan) 및 RYSTIGGO® (rozanolixizumab-noli)에 대한 장기 안전성 및 효능 데이터
- zilucoplan에 대한 RAISE-XT 시험 결과, 120주 중간 분석 포함
- rozanolixizumab에 대한 3상 MycarinG 시험의 사후 분석
- IV 보체 억제제에서 피하 zilucoplan으로의 전환 데이터
- 스테로이드 사용 감소 및 면역억제 치료의 변화에 대한 통찰
이 발표는 UCB의 신경근 연구 분야에서의 리더십과 gMG 치료 진전을 위한 헌신을 강조합니다. UCB는 gMG 치료 선택에 관한 산업 후원 세션도 주최할 예정입니다.
UCB présentera 14 résumés lors de la 2024 AANEM Annual Meeting et de la session scientifique MGFA, mettant en avant de nouvelles données sur ses traitements pour le gMG. Les points clés incluent :
- Données de sécurité et d’efficacité à long terme pour ZILBRYSQ® (zilucoplan) et RYSTIGGO® (rozanolixizumab-noli)
- Résultats de l'essai RAISE-XT pour le zilucoplan, y compris une analyse intérimaire à 120 semaines
- Analyses post hoc de l'essai de Phase 3 MycarinG pour le rozanolixizumab
- Données sur le passage à un traitement sous-cutané de zilucoplan à partir d'inhibiteurs du complément IV
- Perspectives sur la réduction des corticostéroïdes et les changements dans la thérapie immunosuppressive
Les présentations soulignent le leadership d'UCB dans la recherche neuromusculaire et son engagement à faire progresser le traitement du gMG. UCB présentera également une session sponsorisée par l'industrie sur les choix de traitement du gMG.
UCB wird 14 Abstracts auf dem 2024 AANEM Annual Meeting und der MGFA Scientific Session präsentieren und neue Daten zu seinen gMG-Behandlungen vorstellen. Zu den Highlights gehören:
- Langzeit-Sicherheits- und Wirksamkeitsdaten für ZILBRYSQ® (zilucoplan) und RYSTIGGO® (rozanolixizumab-noli)
- Ergebnisse aus der RAISE-XT-Studie für zilucoplan, einschließlich einer zwischenzeitlichen Analyse nach 120 Wochen
- Post-hoc-Analysen der Phase-3-MycarinG-Studie für rozanolixizumab
- Daten zum Wechsel von IV-Komplementhemmern zu subkutanem zilucoplan
- Einblicke in die Reduzierung von Kortikosteroid und Änderungen in der immunsuppressiven Therapie
Die Präsentationen betonen die Führungsrolle von UCB in der neuromuskulären Forschung und das Engagement, den gMG-Behandlungsfortschritt voranzutreiben. UCB wird auch eine industriegesponserte Sitzung zu Behandlungsmöglichkeiten von gMG ausrichten.
- Presentation of 14 abstracts showcasing new data for UCB's gMG treatments
- Long-term safety and efficacy data for ZILBRYSQ® and RYSTIGGO®
- 120-week interim analysis results from the RAISE-XT trial for zilucoplan
- Post hoc analyses from the Phase 3 MycarinG trial for rozanolixizumab
- Data on switching to subcutaneous zilucoplan from IV complement inhibitors
- Insights on corticosteroid sparing and changes in immunosuppressant therapy
- None.
- UCB will contribute 14 presentations, including an oral presentation, selected to feature across the AANEM and MGFA meeting, emphasizing UCB's leadership in neuromuscular research
- Presentations showcase new data for UCB's gMG treatments, including post hoc analyses highlighting the long-term safety and efficacy of ZILBRYSQ® (zilucoplan)1 and RYSTIGGO® (rozanolixizumab-noli) 2
A total of 14 abstracts, including one oral presentation, will feature data from studies of UCB's recently approved medicines for the treatment of gMG, RYSTIGGO® and ZILBRYSQ®, along with findings from real-world studies of clinical outcomes and patient experience in gMG.
"At UCB, we are committed to transforming the lives of those living with generalized myasthenia gravis through ongoing innovation and comprehensive clinical research," commented Manuela Maronati, Global Asset Head, Neuroimmunology & Rare. "Our presentations at the 2024 AANEM Annual Meeting and MGFA Scientific Session underscore our dedication to advancing understanding and treatment of this challenging condition. We are particularly excited to share insights from our RAISE-XT and MycarinG studies, which reflect significant progress in the management of generalized myasthenia gravis."
Key UCB scientific and real-world data to be presented at AANEM and the MGFA Scientific Session include:
- An oral presentation focusing on UCB's innovative work on enhancing global education standards for myasthenia gravis.3
- Phase 3b study results on switching to subcutaneous zilucoplan from IV complement component 5 inhibitors in myasthenia gravis.4
- Data from the RAISE-XT trial for zilucoplan - including an interim analysis of long-term safety and efficacy over a period of up to 120 weeks, compliance to daily self-administered subcutaneous zilucoplan, and a post-hoc analysis of corticosteroid sparing and non-steroidal immunosuppressant therapy changes up to 120 weeks - offering new insights into the management potential for generalized myasthenia gravis in a clinical setting.5,6,7
- For rozanolixizumab, post hoc analyses from the Phase 3 MycarinG trial in patients with generalized myasthenia gravis describe the impact of treatment on specific muscle group weaknesses, evaluate rozanolixizumab in those aged 65 years and older, and highlight its use for individualized treatment regimens.8,9,10
UCB will also host an industry-sponsored therapeutic update session on an expert-led discussion on generalized myasthenia gravis treatment choices on October 16, 2024.
"At this year's AANEM Annual Meeting and MGFA Scientific Session, we are proud to share data from UCB's innovative work, which is advancing the standard of education for generalized myasthenia gravis globally. This program not only underscores our dedication to empowering healthcare professionals with knowledge and tools but also highlights our ongoing commitment to addressing the complex challenges faced by the MG community," commented Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, UCB.
UCB presentations during AANEM and MGFA 2024
Lead author | Abstract title | Presentation Details |
James Howard | Long-term safety and efficacy of zilucoplan in generalized myasthenia gravis: 120-week interim analysis of RAISE-XT | MGFA and AANEM |
Miriam Freimer | Corticosteroid dose tapering during treatment with zilucoplan in patients with generalized myasthenia gravis: 120-week follow-up of RAISE-XT | MGFA and AANEM |
Michael Weiss | Concomitant intravenous immunoglobulin or plasma exchange has no effect on complement inhibition by zilucoplan | MGFA and AANEM |
James Howard | Efficacy of zilucoplan in patients with generalized myasthenia gravis without prior immunoglobulin or plasma exchange treatment in the RAISE study | MGFA and AANEM |
Katherine Ruzhansky | Compliance to daily self-administered subcutaneous zilucoplan in patients with generalized myasthenia gravis: a post hoc analysis of the RAISE-XT study | AANEM |
Miriam Freimer | Switching to subcutaneous zilucoplan from IV complement component 5 inhibitors in myasthenia gravis: A Phase 3b study | MGFA |
Tuan Vu | Non-steroidal immunosuppressant therapy changes during treatment with zilucoplan in patients with generalized myasthenia gravis: 120-week follow-up of RAISE-XT | MGFA |
Tuan Vu | Rozanolixizumab in patients aged ≥65 years with generalized myasthenia gravis: a post hoc analysis of the Phase 3 MycarinG study | MGFA |
Gandhi Mehta | Self-administration of subcutaneous rozanolixizumab in patients with generalized myasthenia gravis: Clinical study design | MGFA and AANEM |
Robert Pascuzzi | Effect of rozanolixizumab on myasthenia gravis–specific outcome subdomain scores: post hoc analyses from the Phase 3 MycarinG study | MGFA |
Ali A. Habib | Rozanolixizumab treatment patterns in patients with generalized myasthenia gravis: post hoc analysis | MGFA |
James Howard | Developing needs-driven medical education for healthcare professionals in myasthenia gravis | MGFA |
Judith Thompson | Social Determinants of Health are Associated with Delayed Diagnosis in Myasthenia Gravis | AANEM |
Judith Thompson | Evidence of Misdiagnosis in Administrative Claims Data for Individuals with Myasthenia Gravis | AANEM |
Additionally, for registered healthcare professionals, UCB has arranged a program of sponsored scientific and therapeutic updates. Visit us at our booth for more information.
UCB
For further information, contact UCB:
Daphne Teo
T +1 (770) 880-7655
daphne.teo@ucb.com
Global Communications
Nick Francis
T: +44 7769 307745
nick.francis@ucb.com
Corporate Communications, Media Relations
Laurent Schots
T +32.2.559.92.64
Laurent.schots@ucb.com
Investor Relations
Antje Witte
T +32.2.559.94.14
antje.witte@ucb.com
IMPORTANT SAFETY INFORMATION ABOUT RYSTIGGO® (rozanolixizumab-noli) in the US2
INDICATION:
RYSTIGGO (rozanolixizumab-noli) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Infections: RYSTIGGO may increase the risk of infection. 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
Immunization with vaccines during RYSTIGGO treatment has not been studied. The safety of immunization with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because RYSTIGGO causes a reduction in 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.
Aseptic Meningitis: 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: Hypersensitivity reactions, including angioedema and rash, were observed in patients treated with RYSTIGGO. Management of hypersensitivity reactions depends on the type and severity of the reaction. Monitor patients during treatment with RYSTIGGO and for 15 minutes after for clinical signs and symptoms of hypersensitivity reactions. If a reaction occurs, institute appropriate measures if needed.
ADVERSE REACTIONS
In a placebo-controlled study, the most common adverse reactions (reported in at least
Please see the full Prescribing Information for additional Important Safety Information.
IMPORTANT SAFETY INFORMATION ABOUT ZILBRYSQ® (zilucoplan) in the US1
INDICATION:
ZILBRYSQ is a complement inhibitor indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors; ZILBRYSQ is a complement inhibitor. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.
- Complete or update meningococcal vaccination (for serogroups A, C, W, and Y, and serogroup B) at least 2 weeks prior to administering the first dose of ZILBRYSQ, unless the risk of delaying therapy outweighs the risk of developing a meningococcal infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccinations in patients receiving a complement inhibitor.
- Persons receiving ZILBRYSQ are at increased risk for invasive disease caused by N. meningitidis, even if they develop antibodies following vaccination. Monitor patients for signs of 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.
CONTRAINDICATIONS
ZILBRYSQ is contraindicated in patients with unresolved Neisseria meningitidis infection.
WARNINGS AND PRECAUTIONS
Serious Meningococcal Infections
Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors; ZILBRYSQ is a complement inhibitor. The use of ZILBRYSQ increases a patient's susceptibility to serious and life-threatening meningococcal infections (septicemia and/or meningitis) caused by any serogroup, including non-groupable strains.
Complete or update meningococcal vaccination (for both serogroups A, C, W, and Y [MenACWY] and serogroup B [MenB]) at least 2 weeks prior to administering the first dose of ZILBRYSQ, according to current ACIP recommendations for meningococcal vaccinations in patients receiving a complement inhibitor.
If urgent ZILBRYSQ therapy is indicated in a patient who is not up to date with both MenACWY and MenB vaccines according to ACIP recommendations, administer meningococcal vaccine(s) as soon as possible and provide the patient with antibacterial drug prophylaxis.
Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Withhold administration of ZILBRYSQ in patients who are undergoing treatment for meningococcal infection until the infection is resolved.
ZILBRYSQ REMS
Due to the risk of meningococcal infections, ZILBRYSQ is available only through a restricted program under a REMS called ZILBRYSQ REMS.
Under the ZILBRYSQ REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccines. Additional information on the REMS requirements is available at www.ZILBRYSQREMS.com or 1-877-414-8353.
Other Infections
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 and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines. Persons receiving ZILBRYSQ are at increased risk for infections due to these bacteria, even after vaccination.
Pancreatitis And Other Pancreatic Conditions
Pancreatitis and pancreatic cysts have been reported in patients treated with ZILBRYSQ. Patients should be informed of this risk before starting ZILBRYSQ. Obtain lipase and amylase levels at baseline before starting treatment with ZILBRYSQ. Discontinue ZILBRYSQ in patients with suspected pancreatitis and initiate appropriate management until pancreatitis is ruled out or has resolved.
ADVERSE REACTIONS
In a placebo-controlled study, the most common adverse reactions (reported in at least
Please see the full Prescribing Information for additional Important Safety Information.
About UCB
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References
1 ZILBRYSQ® US PI. https://www.ucb.com/sites/default/files/2024-01/Zilbrysq_PI_27oct2023.pdf. (Accessed: October 2024).
2 RYSTIGGO® US PI. https://www.ucb.com/sites/default/files/2023-08/Rystiggo_Prescribing_Information_USA.pdf. (Accessed: October 2024).
3 Howard J, et al. Developing needs-driven medical education for healthcare professionals in myasthenia gravis. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18;
4 Freimer M, et al. Switching to subcutaneous zilucoplan from IV complement component 5 inhibitors in myasthenia gravis: A Phase 3b study. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18;
5 Howard J, et al. Long-term safety and efficacy of zilucoplan in generalized myasthenia gravis: 120-week interim analysis of RAISE-XT. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18;
6 Ruzhansky K, et al. Compliance to daily self-administered subcutaneous zilucoplan in patients with generalized myasthenia gravis: a post hoc analysis of the RAISE-XT study. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18;
7 Freimer M, et al. Corticosteroid dose tapering during treatment with zilucoplan in patients with generalized myasthenia gravis: 120-week follow-up of RAISE-XT. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18;
8 Pascuzzi R, et al. Effect of rozanolixizumab on myasthenia gravis–specific outcome subdomain scores: post hoc analyses from the phase 3 MycarinG study. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18;
9 Vu T, et al. Rozanolixizumab in patients aged ≥65 years with generalized myasthenia gravis: a post hoc analysis of the Phase 3 MycarinG study. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18;
10 Ali A. Habib, et al. Rozanolixizumab treatment patterns in patients with generalized myasthenia gravis: post hoc analysis. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18;
RYSTIGGO® and ZILBRYSQ® are registered trademarks of the UCB Group of Companies.
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FAQ
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