010 Real-world experience with ocrelizumab in the MSBase registry – Australian RRMS cohort

Butzkueven, Helmut; Spelman, Tim; Kalinčík, Tomáš; Buzzard, Katherine; Walt, Anneke van der; Lechner-Scott, J.; Hodgkinson, Suzanne; Butler, Ernest; Macdonell, Richard; Slee, Mark; Marcel, Bruno

doi:10.1136/bmjno-2021-anzan.10

Cited by 3 publications

(6 citation statements)

References 2 publications

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“…The low rates of patients discontinuing OCR due to AEs suggest favorable long-term tolerability, which together with its sustained efficacy, contributes to the high persistence observed in real-world cohorts. [15][16][17][18] Fatality rates in the clinical trials remained below those observed in postmarketing settings, as well as the expected fatality rates (0.37-0.90 per 100 PY) observed in real-world MS cohorts. 18,19 It should be noted that postmarketing patients tend to have older age, longer disease duration, higher proportion of progressive MS, and a greater number of previous disease-modifying treatments (DMTs) and comorbidities.…”

Section: Discussionmentioning

confidence: 99%

“…18,19 It should be noted that postmarketing patients tend to have older age, longer disease duration, higher proportion of progressive MS, and a greater number of previous disease-modifying treatments (DMTs) and comorbidities. 15 Whereas IRRs were among the most frequently reported AEs with OCR, most patients did not experience IRRs, and the majority were mild to moderate, decreased with the number of infusions, and were effectively managed through administering premedication, adjustment to infusion rates, and symptomatic treatment. An appropriate premedication protocol with mandatory methylprednisolone and antihistamines, as well as an optional analgesic, was followed.…”

Section: Discussionmentioning

confidence: 99%

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Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis

et al. 2021

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ObjectiveTo report safety of ocrelizumab (OCR) up to 7 years in patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) enrolled in clinical trials or treated in real-world postmarketing settings.MethodsSafety analyses are based on integrated clinical and laboratory data for all patients who received OCR in 11 clinical trials, including the controlled treatment and open-label extension (OLE) periods of the phase 2 and 3 trials, plus the phase 3b trials VELOCE, CHORDS, CASTING, OBOE, ENSEMBLE, CONSONANCE, and LIBERTO. For selected adverse events (AEs), additional postmarketing data were used. Incidence rates of serious infections (SIs) and malignancies were contextualized using multiple epidemiologic sources.ResultsAt data cut-off (January 2020), 5,680 patients with multiple sclerosis (MS) received OCR (18,218 patient years [PY] of exposure) in clinical trials. Rates per 100 PY (95% CI) of AEs (248; 246–251), serious AEs (7.3; 7.0–7.7), infusion-related reactions (25.9; 25.1–26.6), and infections (76.2; 74.9–77.4) were similar to those within the controlled treatment period of the phase 3 trials. Rates of the most common serious AEs, including SIs (2.01; 1.81–2.23) and malignancies (0.46; 0.37–0.57), were consistent with the ranges reported in epidemiologic data.ConclusionContinuous administration of OCR for up to 7 years in clinical trials, as well as its broader use for more than 3 years in the real-world setting, are associated with a favorable and manageable safety profile, without emerging safety concerns in a heterogeneous MS population.Classification of evidenceThis analysis provides Class III evidence that long-term, continuous treatment with OCR has a consistent and favorable safety profile in patients with RMS and PPMS. This study is rated Class III because of the use of OLE data and historical controls.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis

et al. 2021

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“…Compared to a recent smaller US cohort ( 17 ), patients with RMS in CONFIDENCE had similar mean EDSS and fewer patients in CONFIDENCE were treated with first-line ocrelizumab. With respect to ocrelizumab treated patients documented in the global MSBase registry ( 2 ), CONFIDENCE populations had similar age profiles. Patients with RMS tended to have a higher EDSS and proportions of patients without prior therapy were similar.…”

Section: Discussionmentioning

confidence: 99%

“…Ocrelizumab (Ocrevus®) is a monoclonal antibody that specifically binds to CD20, modulating the immunopathogenesis of MS by depleting CD20 + B-cells. As the first anti-CD20 monoclonal antibody approved for the treatment of RMS and PPMS, ocrelizumab remains the only approved treatment for PPMS to date ( 2 , 3 ). Pivotal trial data shows that treatment with ocrelizumab has significant effects on slowing disease progression, annualized relapse rate and magnetic resonance imagery outcomes, with no signal of a higher rate of serious infections, compared with interferon in patients with RMS and placebo in patients with PPMS ( 4 , 5 ).…”

Section: Introductionmentioning

confidence: 99%

Safety, Adherence and Persistence in a Real-World Cohort of German MS Patients Newly Treated With Ocrelizumab: First Insights From the CONFIDENCE Study

et al. 2022

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BackgroundReal-world relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS) populations may be more diverse than in clinical trials. Here, we present a first analysis of safety, adherence and persistence data from a real-world cohort of patients newly treated with ocrelizumab.MethodsCONFIDENCE (ML39632, EUPAS22951) is an ongoing multicenter, non-interventional post authorization safety study assessing patients with RMS or PPMS newly treated with ocrelizumab or other disease-modifying therapies for up to 10 years. For this analysis, patients newly treated with ocrelizumab were analyzed in subgroups by MS phenotype and age over a mean ~1 year of exposure totaling 2,329 patient years [PY]).ResultsAt data cutoff (14 October 2020), 1,702 patients with RMS and 398 patients with PPMS were treated with ≥1 dose of ocrelizumab. At baseline, the mean ages (SD) of patients with RMS and PPMS were 41.59 (11.24) and 50.95 (9.88) years and the mean EDSS (Expanded Disability Status Scale) was 3.18 (1.87) and 4.41 (1.59), respectively. The most common adverse events (AEs) and serious AEs across both phenotypes were infections and infestations, with infection SAE rates of 2.8 events/100 PY and 1.5 events/100 PY in patients with RMS and PPMS, respectively. Across all phenotypes, ocrelizumab persistence was 92% at 24 months; median time between doses was ~6 months.ConclusionsThe ocrelizumab safety profile observed in the CONFIDENCE real-world MS population was consistent to the one observed in pivotal clinical trials. High treatment persistence and adherence were observed.Trial RegistrationML39632, EUPAS22951

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“…Approximately one-third of patients in the pivotal CLARITY trial switched to cladribine tablets from interferon-beta or glatiramer acetate 3 ; however, neither DMF nor teriflunomide treated patients were enrolled as these treatments were approved after the completion of CLARITY. Real-world cohorts published recently report on patients switching from all first-line treatments, including DMF and teriflunomide, however, in a descriptive manner, 17 , 18 or in very small numbers. 19 …”

Section: Discussionmentioning

confidence: 99%

Oral Cladribine in Patients who Change From First-Line Disease Modifying Treatments for Multiple Sclerosis: Protocol of a Prospective Effectiveness and Safety Study (CLAD CROSS)

Tsivgoulis

Deftereos²,

Gobbi

et al. 2022

J Cent Nerv Syst Dis

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Background Recently, the number of available disease modifying therapies for multiple sclerosis (MS) has increased. However, a proportion of patients treated with these agents continue to experience relapses and disease progression. Cladribine tablets, approved in 2017 for highly active relapsing MS, comprise a sparsely administered oral treatment which exerts its therapeutic effect through a reduction and subsequent repletion of the lymphocyte population. Purpose/Study Sample Here we describe the design of CLAD CROSS, a prospective, non-interventional, multicenter, Phase IV study in patients with a confirmed diagnosis of RRMS who switch from first-line disease modifying drugs (DMDs) to treatment with cladribine tablets in routine clinical practice. 242 adult patients will be recruited in 61 sites (6 countries) over 30 months and will be followed up for 2 years following prescription of cladribine tablets per the decision of the treating physicians. Research Design The primary endpoint is the change in annualized relapse rate (ARR) between the 12-month pre-baseline period and over the 12-month period before end of study. Secondary endpoints are the percentage of patients with 6-month disability progression or improvement at the end of the study, measured by the Expanded Disability Status Scale, Timed 25 Foot Walk and 9-Hole Peg Test scales and quality of life, treatment satisfaction, and healthcare resource utilization, measured through the MSIS-29, TSQM 1.4, and EQ-5D-3L scales, respectively. MRI lesions will be compared in the exploratory setting between the 12-month pre-baseline period, baseline, and at years 1 and 2. Adverse events will be monitored throughout the study. Interim analyses are pre-planned when 30% and 60% of patients will complete the 12-month follow-up visit. Conclusions CLAD CROSS will provide efficacy data on cladribine tablets, used as a follow-up treatment to first-line DMDs in the real-world setting, will further establish its safety profile and will collect information to support pharmacoeconomic studies.

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010 Real-world experience with ocrelizumab in the MSBase registry – Australian RRMS cohort

Cited by 3 publications

References 2 publications

Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis

Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis

Safety, Adherence and Persistence in a Real-World Cohort of German MS Patients Newly Treated With Ocrelizumab: First Insights From the CONFIDENCE Study

Oral Cladribine in Patients who Change From First-Line Disease Modifying Treatments for Multiple Sclerosis: Protocol of a Prospective Effectiveness and Safety Study (CLAD CROSS)

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