Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years
Ofatumumab is approved for the treatment of relapsing multiple sclerosis (RMS). Ongoing safety reporting is crucial to understand its long-term benefit-risk profile. Report the safety and tolerability of ofatumumab in RMS after extended treatment up to 3.5 years. Patients completing ASCLEPIOS I/II (...
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| Vydáno v: | Multiple sclerosis Ročník 28; číslo 10; s. 1576 |
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| Médium: | Journal Article |
| Jazyk: | angličtina |
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England
01.09.2022
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| ISSN: | 1477-0970, 1477-0970 |
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| Abstract | Ofatumumab is approved for the treatment of relapsing multiple sclerosis (RMS). Ongoing safety reporting is crucial to understand its long-term benefit-risk profile.
Report the safety and tolerability of ofatumumab in RMS after extended treatment up to 3.5 years.
Patients completing ASCLEPIOS I/II (phase 3), APLIOS, or APOLITOS (phase 2) trials could enter ALITHIOS, a phase 3b, open-label, long-term safety study. We analyzed cumulative data of continuous ofatumumab treatment and of patients newly switched from teriflunomide.
The safety population had 1969 patients: 1292 continuously treated with ofatumumab (median time-at-risk 35.5 months, 3253 patient-years) and 677 newly switched (median time-at-risk 18.3 months, 986 patient-years). A total of 1650 patients (83.8%) had ⩾1 adverse events and 191 (9.7%) had ⩾1 serious adverse events. No opportunistic infections or progressive multifocal leukoencephalopathy events were identified; the risk of malignancies was low. Mean serum immunoglobulin (Ig) G levels remained stable. Mean IgM levels decreased but remained above the lower limit of normal in most. Serious infection incidence was low; decreased Ig levels were not associated with serious infections.
In patients with up to 3.5 years' exposure, ofatumumab was well tolerated, with no new safety risks identified. These findings, with its established effectiveness, support a favorable benefit-risk profile of ofatumumab in RMS. |
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| AbstractList | Ofatumumab is approved for the treatment of relapsing multiple sclerosis (RMS). Ongoing safety reporting is crucial to understand its long-term benefit-risk profile.
Report the safety and tolerability of ofatumumab in RMS after extended treatment up to 3.5 years.
Patients completing ASCLEPIOS I/II (phase 3), APLIOS, or APOLITOS (phase 2) trials could enter ALITHIOS, a phase 3b, open-label, long-term safety study. We analyzed cumulative data of continuous ofatumumab treatment and of patients newly switched from teriflunomide.
The safety population had 1969 patients: 1292 continuously treated with ofatumumab (median time-at-risk 35.5 months, 3253 patient-years) and 677 newly switched (median time-at-risk 18.3 months, 986 patient-years). A total of 1650 patients (83.8%) had ⩾1 adverse events and 191 (9.7%) had ⩾1 serious adverse events. No opportunistic infections or progressive multifocal leukoencephalopathy events were identified; the risk of malignancies was low. Mean serum immunoglobulin (Ig) G levels remained stable. Mean IgM levels decreased but remained above the lower limit of normal in most. Serious infection incidence was low; decreased Ig levels were not associated with serious infections.
In patients with up to 3.5 years' exposure, ofatumumab was well tolerated, with no new safety risks identified. These findings, with its established effectiveness, support a favorable benefit-risk profile of ofatumumab in RMS. Ofatumumab is approved for the treatment of relapsing multiple sclerosis (RMS). Ongoing safety reporting is crucial to understand its long-term benefit-risk profile.BACKGROUNDOfatumumab is approved for the treatment of relapsing multiple sclerosis (RMS). Ongoing safety reporting is crucial to understand its long-term benefit-risk profile.Report the safety and tolerability of ofatumumab in RMS after extended treatment up to 3.5 years.OBJECTIVEReport the safety and tolerability of ofatumumab in RMS after extended treatment up to 3.5 years.Patients completing ASCLEPIOS I/II (phase 3), APLIOS, or APOLITOS (phase 2) trials could enter ALITHIOS, a phase 3b, open-label, long-term safety study. We analyzed cumulative data of continuous ofatumumab treatment and of patients newly switched from teriflunomide.METHODSPatients completing ASCLEPIOS I/II (phase 3), APLIOS, or APOLITOS (phase 2) trials could enter ALITHIOS, a phase 3b, open-label, long-term safety study. We analyzed cumulative data of continuous ofatumumab treatment and of patients newly switched from teriflunomide.The safety population had 1969 patients: 1292 continuously treated with ofatumumab (median time-at-risk 35.5 months, 3253 patient-years) and 677 newly switched (median time-at-risk 18.3 months, 986 patient-years). A total of 1650 patients (83.8%) had ⩾1 adverse events and 191 (9.7%) had ⩾1 serious adverse events. No opportunistic infections or progressive multifocal leukoencephalopathy events were identified; the risk of malignancies was low. Mean serum immunoglobulin (Ig) G levels remained stable. Mean IgM levels decreased but remained above the lower limit of normal in most. Serious infection incidence was low; decreased Ig levels were not associated with serious infections.RESULTSThe safety population had 1969 patients: 1292 continuously treated with ofatumumab (median time-at-risk 35.5 months, 3253 patient-years) and 677 newly switched (median time-at-risk 18.3 months, 986 patient-years). A total of 1650 patients (83.8%) had ⩾1 adverse events and 191 (9.7%) had ⩾1 serious adverse events. No opportunistic infections or progressive multifocal leukoencephalopathy events were identified; the risk of malignancies was low. Mean serum immunoglobulin (Ig) G levels remained stable. Mean IgM levels decreased but remained above the lower limit of normal in most. Serious infection incidence was low; decreased Ig levels were not associated with serious infections.In patients with up to 3.5 years' exposure, ofatumumab was well tolerated, with no new safety risks identified. These findings, with its established effectiveness, support a favorable benefit-risk profile of ofatumumab in RMS.CONCLUSIONIn patients with up to 3.5 years' exposure, ofatumumab was well tolerated, with no new safety risks identified. These findings, with its established effectiveness, support a favorable benefit-risk profile of ofatumumab in RMS. |
| Author | Häring, Dieter A Saccà, Francesco Stoneman, Dee Jehl, Valentine Kieseier, Bernd C Hauser, Stephen L Mancione, Linda Pingili, Ratnakar Kappos, Ludwig Zielman, Ronald Cross, Anne H Das Gupta, Ayan Nicholas, Jacqueline Giacomini, Paul S Winthrop, Kevin Willi, Roman Wiendl, Heinz Bagger, Morten Meuth, Sven G Su, Wendy |
| Author_xml | – sequence: 1 givenname: Stephen L orcidid: 0000-0002-4932-4001 surname: Hauser fullname: Hauser, Stephen L organization: UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA – sequence: 2 givenname: Anne H orcidid: 0000-0003-0829-7569 surname: Cross fullname: Cross, Anne H organization: Washington University School of Medicine, St Louis, MO, USA – sequence: 3 givenname: Kevin surname: Winthrop fullname: Winthrop, Kevin organization: Oregon Health & Sciences University, Portland, OR, USA – sequence: 4 givenname: Heinz orcidid: 0000-0003-4310-3432 surname: Wiendl fullname: Wiendl, Heinz organization: Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany – sequence: 5 givenname: Jacqueline surname: Nicholas fullname: Nicholas, Jacqueline organization: OhioHealth Multiple Sclerosis Center, Riverside Methodist Hospital, Columbus, OH, USA – sequence: 6 givenname: Sven G surname: Meuth fullname: Meuth, Sven G organization: Department of Neurology, University Hospital Düsseldorf, Düsseldorf, Germany – sequence: 7 givenname: Paul S orcidid: 0000-0002-1346-3042 surname: Giacomini fullname: Giacomini, Paul S organization: Department of Neurology and Neurosurgery, Montreal Neurological Institute, McGill University, Montreal, QC, Canada – sequence: 8 givenname: Francesco orcidid: 0000-0002-1323-6317 surname: Saccà fullname: Saccà, Francesco organization: Department of Neurosciences, Odontostomatological and Reproductive Sciences, University Federico II, Naples, Italy – sequence: 9 givenname: Linda surname: Mancione fullname: Mancione, Linda organization: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA – sequence: 10 givenname: Ronald surname: Zielman fullname: Zielman, Ronald organization: Novartis Pharma BV, Amsterdam, the Netherlands – sequence: 11 givenname: Morten surname: Bagger fullname: Bagger, Morten organization: Novartis Pharma AG, Basel, Switzerland – sequence: 12 givenname: Ayan surname: Das Gupta fullname: Das Gupta, Ayan organization: Novartis Healthcare Pvt. Ltd, Hyderabad, Telangana, India – sequence: 13 givenname: Dieter A surname: Häring fullname: Häring, Dieter A organization: Novartis Pharma AG, Basel, Switzerland – sequence: 14 givenname: Valentine surname: Jehl fullname: Jehl, Valentine organization: Novartis Pharma AG, Basel, Switzerland – sequence: 15 givenname: Bernd C surname: Kieseier fullname: Kieseier, Bernd C organization: Novartis Pharma AG, Basel, Switzerland and Department of Neurology, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany – sequence: 16 givenname: Ratnakar surname: Pingili fullname: Pingili, Ratnakar organization: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA – sequence: 17 givenname: Dee surname: Stoneman fullname: Stoneman, Dee organization: Novartis Pharma AG, Basel, Switzerland – sequence: 18 givenname: Wendy surname: Su fullname: Su, Wendy organization: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA – sequence: 19 givenname: Roman orcidid: 0000-0001-9612-9877 surname: Willi fullname: Willi, Roman organization: Novartis Pharma AG, Basel, Switzerland – sequence: 20 givenname: Ludwig orcidid: 0000-0003-4175-5509 surname: Kappos fullname: Kappos, Ludwig organization: Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB) and MS Center, Departments of Head, Spine and Neuromedicine, Clinical Research, Biomedicine, Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland |
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| Title | Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years |
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