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"Bhatt, Alit"
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Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results
Background:
Multiple sclerosis (MS) is a chronic disease that may require decades of ongoing treatment. Therefore, the long-term safety and efficacy of disease-modifying therapies is an important consideration.
Methods:
The LONGTERMS study evaluated the safety and efficacy of fingolimod in patients with relapsing MS (RMS) with up to 14 years of exposure. This phase IIIb, open-label extension study included patients aged ⩾ 18 years with confirmed RMS diagnosis who completed previous phase II/III/IIIb core/extension studies of fingolimod. Patients received fingolimod 0.5 mg orally once daily; safety and efficacy (clinical and magnetic resonance imaging) were the main outcomes.
Results:
Of 4086 patients from the core studies who entered LONGTERMS, 3480 (85.2%) completed the study. The median age (range) was 38 (17–65) years and median fingolimod exposure was 944.5 (range 75–4777) days. Overall, 85.5% of patients experienced at least one adverse event (AE); most common AEs (⩾10%) were viral upper respiratory tract infection (17.3%), headache (13.3%), hypertension (11.0%) and lymphopenia (10.7%). Among patients with serious AEs (12.6%), basal cell carcinoma and MS relapse (0.9% each) were most frequently reported. The aggregate annualized relapse rate decreased from 0.22 (in years 0–2) to 0.17 (years 0–10); 45.5% of patients remained relapse free after 10 years. At year 10, 63.2% of patients were free from 6-month confirmed disability worsening.
Conclusion:
This long-term observational study of patients treated for up to 14 years with fingolimod confirmed its established safety profile with no new safety concerns. Patients with RMS receiving fingolimod had sustained low levels of disease activity and progression.
Trial Registration:
ClinicalTrials.gov identifier: NCT01201356.
Journal Article
THUR 173 Longterms: 10-year experience of fingolimod in RRMS patients
ObjectivesPresent results for up to 10 years of fingolimod treatment in RRMS patients.MethodsLONGTERMS is an open-label, single-arm, extension study evaluating the long-term safety, tolerability and efficacy of fingolimod in patients who previously participated in earlier fingolimod studies. Key efficacy measures: annualised relapse rate (ARR), proportion of patients free of 6 month confirmed disability progression (6 m-CDP), annualised rate of new or newly enlarging T2 lesions (ARneT2), and annualised rate of brain atrophy (ARBA). Safety analyses: adverse events (AEs) and serious AEs (SAEs) frequencies.Results3168 patients were included in the analysis. ARR decreased with longer exposure from 0.26 (Month [M] 0–12) to 0.20 (M0–60) and 0.19 (M0–120). Most patients remained free from 6 m-CDP at M60 (79.3%) and M120 (68.1%). ARneT2 decreased from 1.31 (M0–12) to 0.90 (M0–60), and 0.71 (M0–120). Change in brain volume was stable throughout the study (−0.37 [M12], −0.33 [M60] and −0.32 [M120]). Long-term exposure did not raise new safety concerns. No increase in frequencies of AEs or SAEs per year was observed over long-term fingolimod treatment.ConclusionsLong-term follow-up confirmed the established safety profile of fingolimod. Treatment was associated with a sustained low level of disease activity as expressed by clinical and MRI outcomes.DisclaimerPreviously presented at ECTRIMS 2017
Journal Article
3003 Prognostic value of on-treatment serum neurofilament light chain for neT2 lesions relapsing MS patients: pooled analysis of ASCLEPIOS I/II
ObjectivesTo evaluate the prognostic value of 3- and 12-month on-treatment serum neurofilament light chain (sNfL) levels for future disease activity in with relapsing multiple sclerosis[pwRMS]MethodsA baseline sNfL cut-off was predefined by the median sNfL value across the ofatumumab ASCLEPIOS I/II Phase 3 clinical trials and participants were stratified into high (≥baseline median [≥9.3 pg/mL]) and low (
Journal Article
3544 Long-term ofatumumab treatment over 6 years did not increase the risk of serious infections
BackgroundThis study evaluated the yearly risk of developing serious infections (SIs) with ofatumumab (OMB) treatment over a period of 6 years (cutoff date: 25-Sep-2023) in pwRMS.MethodsParticipants who received at least one dose of OMB in ASCLEPIOS I/II, APLIOS, APOLITOS or ALITHIOS were included, and data from OMB first dose analysed. SIs (infections classified by the investigator as serious adverse events under the System Organ Class of Infections and infestations) were analysed by risk categories including respiratory tract infections (RTls) (excluding COVID-19), COVID-19, appendicitis, urinary tract infections (UTls), herpes viral infections and others. Annualised rate of SIs for each year was estimated by negative binomial regression model, with cumulative infection count in each patient in the year as the response variable, year as a factor and time at risk in the year as an offset variable.ResultsOf 1969 participants included in the analysis (cumulative exposure, 8042.7 PYs), 115 participants (5.84%) had 130 SIs over 6 years. Most commonly reported SIs were COVID-19 (n=49; 2.49%), UTI (n=16; 0.81%), lower RTI (n=16; 0.81%), and appendicitis (n=15; 0.76%). The annualised rates (95% Cl) of SIs excluding COVID-19 were low throughout 6 years of treatment (Year 1, 0.013 [0.008–0.021); Year 2, 0.010 [0.006–0.017); Year 3, 0.011 [0.006–0.018]; Year 4, 0.006 [0.003–0.013]; Year 5, 0.007 [0.003–0.017]; and Year 6, 0.010 [0.004–0.025)).ConclusionThe results show that long-term use of ofatumumab did not increase the risk of SIs over 6 years, supporting the favourable long-term safety profile of ofatumumab in pwRMS.
Journal Article
3549 Continuous ofatumumab treatment up to 7 years shows a consistent safety profile and delays disability progression in people with RMS
Background/ObjectivesPreviously reported data up to 6 years of ofatumumab treatment demonstrated a favourable safety profile and sustained efficacy. Here we describe long-term safety of ofatumumab and assess disability outcomes (up to 7 years) of early initiation of ofatumumab treatment versus delayed treatment (after switching from teriflunomide) in people with relapsing multiple sclerosis (pwRMS).MethodsSafety analyses include participants who received ≥1 dose of ofatumumab in ASCLEPIOS I/II, APOLITOS, APLIOS, or ALITHIOS. Efficacy analyses evaluate cumulative data up to 7 years (cutoff: 25-Sep-2024) from pwRMS randomized to ofatumumab or teriflunomide in ASCLEPIOS I/II, regardless of whether they entered the ALITHIOS open-label extension phase. Event rates of 3/6-month (m) confirmed disability worsening (3/6mCDW), progression independent of relapse activity (3/6mPIRA; CDW events without prior confirmed relapses), and relapse-associated disability worsening (3/6mRAW; disability onset <90 days from relapse) will be assessed.ResultsExposure-adjusted incidence rates of adverse events (AEs), serious AEs, serious infections, and malignancies remained low and consistent, with no increased risk over 6 years. Previously reported 6-year data (cutoff: 25-Sep-2023) showed Kaplan-Meier cumulative event rates were numerically lower in pwRMS receiving continuous ofatumumab in ASCLEPIOS I/II and ALITHIOS (OMB-OMB) versus delayed treatment (TER-OMB) for 6mCDW (21.1% vs 24.8%, p=0.063), 6mPIRA (15.5% vs 16.6%), and 6mRAW (5.2% vs 5.8%). Updated 7-year safety and efficacy data will be presented at the congress.ConclusionThese analyses will further support long-term safety and efficacy data for ofatumumab in pwRMS, including RDTN pwRMS, informing clinical decision-making.
Journal Article