Switching to subcutaneous zilucoplan from intravenous complement component 5 inhibitors in generalised myasthenia gravis: a phase IIIb, open-label study
Experiences of patients with myasthenia gravis who switched their treatments from intravenous infusions of ravulizumab or eculizumab to self-administered daily injections of zilucoplan: effects on symptoms, safety, and patient preference Myasthenia gravis (MG) is a chronic autoimmune disease. Comple...
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| Published in | Therapeutic advances in neurological disorders Vol. 18; p. 17562864251347283 |
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| Main Authors | , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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England
SAGE Publications
01.01.2025
SAGE Publishing |
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| Online Access | Get full text |
| ISSN | 1756-2864 1756-2856 1756-2864 |
| DOI | 10.1177/17562864251347283 |
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| Abstract | Experiences of patients with myasthenia gravis who switched their treatments from intravenous infusions of ravulizumab or eculizumab to self-administered daily injections of zilucoplan: effects on symptoms, safety, and patient preference
Myasthenia gravis (MG) is a chronic autoimmune disease. Complement, part of the immune system, is overactive in MG. This damages the connections between muscles and nerves, causing muscle weakness. Symptoms can be reduced by blocking complement activity. Ravulizumab and eculizumab are complement inhibitors that are given as intravenous (into a vein) infusions by a healthcare professional in a hospital or clinic. Zilucoplan is another type of complement inhibitor, which patients can inject subcutaneously (under the skin) themselves. This study followed patients with MG who wanted to switch from ravulizumab or eculizumab to zilucoplan. Side effects were recorded throughout the study. Patients’ symptoms were measured to see if there was any change since switching treatment. All 26 patients who enrolled in the study had stable symptoms with their current treatment (which was ravulizumab in 10 patients, and eculizumab in 16 patients). Once enrolled, patients switched to daily zilucoplan for 12 weeks. Their main reasons for wanting to switch treatment were challenges with intravenous infusions, including travelling to hospital and long infusion times. Some patients also felt their current treatment was wearing off. After 12 weeks of zilucoplan treatment, symptoms across the group as a whole had improved. Symptoms had either improved or stayed the same in approximately 75% of patients. Symptom improvements were greatest in patients who switched from ravulizumab to zilucoplan. At the end of the study, 76.9% (20 out of 26) patients said they preferred injections with zilucoplan to intravenous infusions of their previous treatment. Side effects occurred in 73.1% of patients, which were mostly mild. Although the study was short and limited to a small number of patients, the results suggest that switching to zilucoplan is an option for patients with MG who would prefer self-injections to intravenous infusions. Longer-term studies are needed to confirm these findings. |
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| AbstractList | Background: Zilucoplan, a peptide complement component 5 (C5) inhibitor, is self-administered as a subcutaneous (SC) injection, which offers an alternative to intravenous infusion of antibody-based complement C5 inhibitors. Objective: To evaluate subcutaneous zilucoplan in adults with acetylcholine receptor autoantibody-positive generalised myasthenia gravis (gMG) who switched from intravenous complement C5 inhibitors to zilucoplan. Design: MG0017 (NCT05514873) was a phase IIIb, open-label, single-arm study. Methods: Eligible patients had clinically stable gMG on an intravenous complement C5 inhibitor and were willing to switch to zilucoplan. Patients received a 12-week treatment period of daily subcutaneous zilucoplan 0.3 mg/kg. Incidence of treatment-emergent adverse events (TEAEs) was the primary endpoint. Change from baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 12 was a secondary endpoint. Treatment preference (Week 12) and treatment satisfaction (9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9)) were both exploratory endpoints. Assessments by prior intravenous complement C5 inhibitor were conducted post hoc. Results: Twenty-six patients enrolled and received zilucoplan; 16 switched from eculizumab and 10 from ravulizumab. TEAEs occurred in 19/26 (73.1%) patients and were mostly mild in severity. At Week 12, least squares (LS) mean (95% confidence interval) MG-ADL scores improved from baseline by −1.15 (−2.11, −0.19), p = 0.0217 and Quantitative MG (QMG) scores by −1.24 (−2.64, 0.16), p = 0.0802. Clinically meaningful improvement from baseline in mean MG-ADL and QMG scores was observed at Week 12 among patients who switched from ravulizumab (−2.41 (−4.52, −0.30; p = 0.0307) and −3.52 (−6.14, −0.90; p = 0.0149), respectively). At Week 12, 76.9% ( n = 20) patients preferred subcutaneous injection compared with intravenous infusion. Mean (standard deviation) changes from baseline in the TSQM-9 Global Satisfaction, Effectiveness and Convenience subscores at Week 12 were +19.410 (27.429), +13.889 (21.534) and +21.739 (19.955), respectively. Complement inhibition increased from baseline and was complete (>95%) by Week 2 and maintained to Week 12. Conclusion: Zilucoplan demonstrated a favourable safety profile. gMG symptoms improved during zilucoplan treatment; this was clinically meaningful for those switching from ravulizumab. Trial registration: ClinicalTrials.gov (NCT05514873); 22 August 2022. https://clinicaltrials.gov/study/NCT05514873 Experiences of patients with myasthenia gravis who switched their treatments from intravenous infusions of ravulizumab or eculizumab to self-administered daily injections of zilucoplan: effects on symptoms, safety, and patient preference Myasthenia gravis (MG) is a chronic autoimmune disease. Complement, part of the immune system, is overactive in MG. This damages the connections between muscles and nerves, causing muscle weakness. Symptoms can be reduced by blocking complement activity. Ravulizumab and eculizumab are complement inhibitors that are given as intravenous (into a vein) infusions by a healthcare professional in a hospital or clinic. Zilucoplan is another type of complement inhibitor, which patients can inject subcutaneously (under the skin) themselves. This study followed patients with MG who wanted to switch from ravulizumab or eculizumab to zilucoplan. Side effects were recorded throughout the study. Patients’ symptoms were measured to see if there was any change since switching treatment. All 26 patients who enrolled in the study had stable symptoms with their current treatment (which was ravulizumab in 10 patients, and eculizumab in 16 patients). Once enrolled, patients switched to daily zilucoplan for 12 weeks. Their main reasons for wanting to switch treatment were challenges with intravenous infusions, including travelling to hospital and long infusion times. Some patients also felt their current treatment was wearing off. After 12 weeks of zilucoplan treatment, symptoms across the group as a whole had improved. Symptoms had either improved or stayed the same in approximately 75% of patients. Symptom improvements were greatest in patients who switched from ravulizumab to zilucoplan. At the end of the study, 76.9% (20 out of 26) patients said they preferred injections with zilucoplan to intravenous infusions of their previous treatment. Side effects occurred in 73.1% of patients, which were mostly mild. Although the study was short and limited to a small number of patients, the results suggest that switching to zilucoplan is an option for patients with MG who would prefer self-injections to intravenous infusions. Longer-term studies are needed to confirm these findings. Zilucoplan, a peptide complement component 5 (C5) inhibitor, is self-administered as a subcutaneous (SC) injection, which offers an alternative to intravenous infusion of antibody-based complement C5 inhibitors. To evaluate subcutaneous zilucoplan in adults with acetylcholine receptor autoantibody-positive generalised myasthenia gravis (gMG) who switched from intravenous complement C5 inhibitors to zilucoplan. MG0017 (NCT05514873) was a phase IIIb, open-label, single-arm study. Eligible patients had clinically stable gMG on an intravenous complement C5 inhibitor and were willing to switch to zilucoplan. Patients received a 12-week treatment period of daily subcutaneous zilucoplan 0.3 mg/kg. Incidence of treatment-emergent adverse events (TEAEs) was the primary endpoint. Change from baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 12 was a secondary endpoint. Treatment preference (Week 12) and treatment satisfaction (9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9)) were both exploratory endpoints. Assessments by prior intravenous complement C5 inhibitor were conducted post hoc. Twenty-six patients enrolled and received zilucoplan; 16 switched from eculizumab and 10 from ravulizumab. TEAEs occurred in 19/26 (73.1%) patients and were mostly mild in severity. At Week 12, least squares (LS) mean (95% confidence interval) MG-ADL scores improved from baseline by -1.15 (-2.11, -0.19), = 0.0217 and Quantitative MG (QMG) scores by -1.24 (-2.64, 0.16), = 0.0802. Clinically meaningful improvement from baseline in mean MG-ADL and QMG scores was observed at Week 12 among patients who switched from ravulizumab (-2.41 (-4.52, -0.30; = 0.0307) and -3.52 (-6.14, -0.90; = 0.0149), respectively). At Week 12, 76.9% ( = 20) patients preferred subcutaneous injection compared with intravenous infusion. Mean (standard deviation) changes from baseline in the TSQM-9 Global Satisfaction, Effectiveness and Convenience subscores at Week 12 were +19.410 (27.429), +13.889 (21.534) and +21.739 (19.955), respectively. Complement inhibition increased from baseline and was complete (>95%) by Week 2 and maintained to Week 12. Zilucoplan demonstrated a favourable safety profile. gMG symptoms improved during zilucoplan treatment; this was clinically meaningful for those switching from ravulizumab. ClinicalTrials.gov (NCT05514873); 22 August 2022. https://clinicaltrials.gov/study/NCT05514873. Zilucoplan, a peptide complement component 5 (C5) inhibitor, is self-administered as a subcutaneous (SC) injection, which offers an alternative to intravenous infusion of antibody-based complement C5 inhibitors.BackgroundZilucoplan, a peptide complement component 5 (C5) inhibitor, is self-administered as a subcutaneous (SC) injection, which offers an alternative to intravenous infusion of antibody-based complement C5 inhibitors.To evaluate subcutaneous zilucoplan in adults with acetylcholine receptor autoantibody-positive generalised myasthenia gravis (gMG) who switched from intravenous complement C5 inhibitors to zilucoplan.ObjectiveTo evaluate subcutaneous zilucoplan in adults with acetylcholine receptor autoantibody-positive generalised myasthenia gravis (gMG) who switched from intravenous complement C5 inhibitors to zilucoplan.MG0017 (NCT05514873) was a phase IIIb, open-label, single-arm study.DesignMG0017 (NCT05514873) was a phase IIIb, open-label, single-arm study.Eligible patients had clinically stable gMG on an intravenous complement C5 inhibitor and were willing to switch to zilucoplan. Patients received a 12-week treatment period of daily subcutaneous zilucoplan 0.3 mg/kg. Incidence of treatment-emergent adverse events (TEAEs) was the primary endpoint. Change from baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 12 was a secondary endpoint. Treatment preference (Week 12) and treatment satisfaction (9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9)) were both exploratory endpoints. Assessments by prior intravenous complement C5 inhibitor were conducted post hoc.MethodsEligible patients had clinically stable gMG on an intravenous complement C5 inhibitor and were willing to switch to zilucoplan. Patients received a 12-week treatment period of daily subcutaneous zilucoplan 0.3 mg/kg. Incidence of treatment-emergent adverse events (TEAEs) was the primary endpoint. Change from baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 12 was a secondary endpoint. Treatment preference (Week 12) and treatment satisfaction (9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9)) were both exploratory endpoints. Assessments by prior intravenous complement C5 inhibitor were conducted post hoc.Twenty-six patients enrolled and received zilucoplan; 16 switched from eculizumab and 10 from ravulizumab. TEAEs occurred in 19/26 (73.1%) patients and were mostly mild in severity. At Week 12, least squares (LS) mean (95% confidence interval) MG-ADL scores improved from baseline by -1.15 (-2.11, -0.19), p = 0.0217 and Quantitative MG (QMG) scores by -1.24 (-2.64, 0.16), p = 0.0802. Clinically meaningful improvement from baseline in mean MG-ADL and QMG scores was observed at Week 12 among patients who switched from ravulizumab (-2.41 (-4.52, -0.30; p = 0.0307) and -3.52 (-6.14, -0.90; p = 0.0149), respectively). At Week 12, 76.9% (n = 20) patients preferred subcutaneous injection compared with intravenous infusion. Mean (standard deviation) changes from baseline in the TSQM-9 Global Satisfaction, Effectiveness and Convenience subscores at Week 12 were +19.410 (27.429), +13.889 (21.534) and +21.739 (19.955), respectively. Complement inhibition increased from baseline and was complete (>95%) by Week 2 and maintained to Week 12.ResultsTwenty-six patients enrolled and received zilucoplan; 16 switched from eculizumab and 10 from ravulizumab. TEAEs occurred in 19/26 (73.1%) patients and were mostly mild in severity. At Week 12, least squares (LS) mean (95% confidence interval) MG-ADL scores improved from baseline by -1.15 (-2.11, -0.19), p = 0.0217 and Quantitative MG (QMG) scores by -1.24 (-2.64, 0.16), p = 0.0802. Clinically meaningful improvement from baseline in mean MG-ADL and QMG scores was observed at Week 12 among patients who switched from ravulizumab (-2.41 (-4.52, -0.30; p = 0.0307) and -3.52 (-6.14, -0.90; p = 0.0149), respectively). At Week 12, 76.9% (n = 20) patients preferred subcutaneous injection compared with intravenous infusion. Mean (standard deviation) changes from baseline in the TSQM-9 Global Satisfaction, Effectiveness and Convenience subscores at Week 12 were +19.410 (27.429), +13.889 (21.534) and +21.739 (19.955), respectively. Complement inhibition increased from baseline and was complete (>95%) by Week 2 and maintained to Week 12.Zilucoplan demonstrated a favourable safety profile. gMG symptoms improved during zilucoplan treatment; this was clinically meaningful for those switching from ravulizumab.ConclusionZilucoplan demonstrated a favourable safety profile. gMG symptoms improved during zilucoplan treatment; this was clinically meaningful for those switching from ravulizumab.ClinicalTrials.gov (NCT05514873); 22 August 2022. https://clinicaltrials.gov/study/NCT05514873.Trial registrationClinicalTrials.gov (NCT05514873); 22 August 2022. https://clinicaltrials.gov/study/NCT05514873. |
| Author | Lavrov, Andreea Singh, Puneet Howard, James F. Desai, Urvi Boroojerdi, Babak Levine, Todd Khan, Shaida Govindarajan, Raghav Delicha, Eumorphia Maria Kang, Min K. Shieh, Perry B. Bloemers, Jos Macwan, Samir Khatri, Bhupendra Freimer, Miriam Weiss, Michael D. |
| Author_xml | – sequence: 1 givenname: Miriam surname: Freimer fullname: Freimer, Miriam organization: Department of Neurology, The Ohio State University Wexner Medical Center, 395 West 12th Avenue, 7th Floor, Columbus, OH 43210, USA – sequence: 2 givenname: Urvi surname: Desai fullname: Desai, Urvi organization: Atrium Health, Wake Forest University, Charlotte, NC, USA – sequence: 3 givenname: Raghav surname: Govindarajan fullname: Govindarajan, Raghav organization: HSHS St. Elizabeth’s Hospital, O’Fallon, IL, USA – sequence: 4 givenname: Min K. surname: Kang fullname: Kang, Min K. organization: Department of Neurology, University of California San Francisco, San Francisco, CA, USA – sequence: 5 givenname: Shaida surname: Khan fullname: Khan, Shaida organization: Department of Neurology, UT Southwestern Medical Center, Dallas, TX, USA – sequence: 6 givenname: Bhupendra surname: Khatri fullname: Khatri, Bhupendra organization: The Regional MS Center and Center for Neurological Disorders, Milwaukee, WI, USA – sequence: 7 givenname: Todd surname: Levine fullname: Levine, Todd organization: HonorHealth Neurology, Bob Bové Neuroscience Institute, Scottsdale, AZ, USA – sequence: 8 givenname: Samir surname: Macwan fullname: Macwan, Samir organization: Department of Neurology, Eisenhower Health, Rancho Mirage, CA, USA – sequence: 9 givenname: Perry B. surname: Shieh fullname: Shieh, Perry B. organization: Department of Neurology and Pediatrics, University of California Los Angeles, Los Angeles, CA, USA – sequence: 10 givenname: Michael D. surname: Weiss fullname: Weiss, Michael D. organization: Department of Neurology, University of Washington Medical Center, Seattle, WA, USA – sequence: 11 givenname: Jos surname: Bloemers fullname: Bloemers, Jos organization: UCB, Brussels, Belgium – sequence: 12 givenname: Babak surname: Boroojerdi fullname: Boroojerdi, Babak organization: UCB, Monheim, Germany – sequence: 13 givenname: Eumorphia Maria surname: Delicha fullname: Delicha, Eumorphia Maria organization: UCB, Braine-l’Alleud, Belgium – sequence: 14 givenname: Andreea surname: Lavrov fullname: Lavrov, Andreea organization: UCB, Monheim, Germany – sequence: 15 givenname: Puneet surname: Singh fullname: Singh, Puneet organization: UCB, Slough, UK – sequence: 16 givenname: James F. orcidid: 0000-0002-7136-8617 surname: Howard fullname: Howard, James F. organization: Department of Neurology, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA |
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| Cites_doi | 10.1016/S1474-4422(15)00145-3 10.1016/j.jcf.2012.04.007 10.2147/PPA.S303279 10.3389/fimmu.2023.1213920 10.1056/EVIDoa2100066 10.1186/1477-7525-7-36 10.1111/j.1749-6632.1998.tb11015.x 10.1016/S1474-4422(17)30369-1 10.1080/13543784.2021.1897567 10.1002/mus.22140 10.1001/jamaneurol.2019.5125 10.57264/cer-2023-0171 10.1186/s41687-023-00594-8 10.1016/S1474-4422(23)00080-7 10.1212/WNL.0000000000205274 10.1177/17562864241243186 10.1038/s41572-019-0079-y 10.1002/mus.23988 10.1002/mus.25198 10.1212/WNL.52.7.1487 |
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| References_xml | – ident: e_1_3_4_2_2 doi: 10.1016/S1474-4422(15)00145-3 – volume-title: Compliance to daily self-administered subcutaneous zilucoplan in patients with generalized myasthenia gravis: a post hoc analysis of the RAISE-XT study year: 2024 ident: e_1_3_4_29_2 – ident: e_1_3_4_24_2 doi: 10.1016/j.jcf.2012.04.007 – ident: e_1_3_4_15_2 – ident: e_1_3_4_9_2 – ident: e_1_3_4_13_2 doi: 10.2147/PPA.S303279 – ident: e_1_3_4_10_2 doi: 10.3389/fimmu.2023.1213920 – ident: e_1_3_4_7_2 doi: 10.1056/EVIDoa2100066 – ident: e_1_3_4_23_2 doi: 10.1186/1477-7525-7-36 – ident: e_1_3_4_20_2 doi: 10.1111/j.1749-6632.1998.tb11015.x – ident: e_1_3_4_5_2 doi: 10.1016/S1474-4422(17)30369-1 – ident: e_1_3_4_25_2 – ident: e_1_3_4_4_2 doi: 10.1080/13543784.2021.1897567 – ident: e_1_3_4_17_2 doi: 10.1002/mus.22140 – ident: e_1_3_4_11_2 doi: 10.1001/jamaneurol.2019.5125 – ident: e_1_3_4_14_2 doi: 10.57264/cer-2023-0171 – ident: e_1_3_4_22_2 doi: 10.1186/s41687-023-00594-8 – ident: e_1_3_4_8_2 – ident: e_1_3_4_6_2 doi: 10.1016/S1474-4422(23)00080-7 – ident: e_1_3_4_16_2 – volume-title: Concomitant intravenous immunoglobulin or plasma exchange has no effect on complement inhibition by zilucoplan year: 2024 ident: e_1_3_4_26_2 – ident: e_1_3_4_28_2 doi: 10.1212/WNL.0000000000205274 – ident: e_1_3_4_12_2 doi: 10.1177/17562864241243186 – ident: e_1_3_4_3_2 doi: 10.1038/s41572-019-0079-y – ident: e_1_3_4_19_2 doi: 10.1002/mus.23988 – ident: e_1_3_4_27_2 – ident: e_1_3_4_21_2 doi: 10.1002/mus.25198 – ident: e_1_3_4_18_2 doi: 10.1212/WNL.52.7.1487 |
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| Snippet | Experiences of patients with myasthenia gravis who switched their treatments from intravenous infusions of ravulizumab or eculizumab to self-administered daily... Zilucoplan, a peptide complement component 5 (C5) inhibitor, is self-administered as a subcutaneous (SC) injection, which offers an alternative to intravenous... Background: Zilucoplan, a peptide complement component 5 (C5) inhibitor, is self-administered as a subcutaneous (SC) injection, which offers an alternative to... |
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| Title | Switching to subcutaneous zilucoplan from intravenous complement component 5 inhibitors in generalised myasthenia gravis: a phase IIIb, open-label study |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/40620733 https://www.proquest.com/docview/3227638455 https://pubmed.ncbi.nlm.nih.gov/PMC12228924 https://doaj.org/article/df1d4711d7b746c481c3ad02d94f50ee |
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