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Page 1
Teriflunomide and Time to Clinical Multiple Sclerosis in Patients With Radiologically Isolated Syndrome: The TERIS Randomized Clinical Trial.
Lebrun-Frénay C, Siva A, Sormani MP, Landes-Chateau C, Mondot L, Bovis F, Vermersch P, Papeix C, Thouvenot E, Labauge P, Durand-Dubief F, Efendi H, Le Page E, Terzi M, Derache N, Bourre B, Hoepner R, Karabudak R, De Seze J, Ciron J, Clavelou P, Wiertlewski S, Turan OF, Yucear N, Cohen M, Azevedo C, Kantarci OH, Okuda DT, Pelletier D; TERIS Study Group. Lebrun-Frénay C, et al. JAMA Neurol. 2023 Oct 1;80(10):1080-1088. doi: 10.1001/jamaneurol.2023.2815. JAMA Neurol. 2023. PMID: 37603328 Free PMC article. Clinical Trial.
Eighty-nine participants (mean [SD] age, 37.8 [12.1] years; 63 female [70.8%]) were enrolled (placebo, 45 [50.6%]; teriflunomide, 44 [49.4%]). Eighteen participants (placebo, 9 [50.0%]; teriflunomide, 9 [50.0%]) discontinued the study, resulting in a dropout rate of …
Eighty-nine participants (mean [SD] age, 37.8 [12.1] years; 63 female [70.8%]) were enrolled (placebo, 45 [50.6%]; teriflunomide, 44 …
Ofatumumab versus Teriflunomide in Multiple Sclerosis.
Hauser SL, Bar-Or A, Cohen JA, Comi G, Correale J, Coyle PK, Cross AH, de Seze J, Leppert D, Montalban X, Selmaj K, Wiendl H, Kerloeguen C, Willi R, Li B, Kakarieka A, Tomic D, Goodyear A, Pingili R, Häring DA, Ramanathan K, Merschhemke M, Kappos L; ASCLEPIOS I and ASCLEPIOS II Trial Groups. Hauser SL, et al. N Engl J Med. 2020 Aug 6;383(6):546-557. doi: 10.1056/NEJMoa1917246. N Engl J Med. 2020. PMID: 32757523 Clinical Trial.
BACKGROUND: Ofatumumab, a subcutaneous anti-CD20 monoclonal antibody, selectively depletes B cells. Teriflunomide, an oral inhibitor of pyrimidine synthesis, reduces T-cell and B-cell activation. ...RESULTS: Overall, 946 patients were assigned to receive ofatumumab and 936 …
BACKGROUND: Ofatumumab, a subcutaneous anti-CD20 monoclonal antibody, selectively depletes B cells. Teriflunomide, an oral inhibitor …
Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis.
Steinman L, Fox E, Hartung HP, Alvarez E, Qian P, Wray S, Robertson D, Huang D, Selmaj K, Wynn D, Cutter G, Mok K, Hsu Y, Xu Y, Weiss MS, Bosco JA, Power SA, Lee L, Miskin HP, Cree BAC; ULTIMATE I and ULTIMATE II Investigators. Steinman L, et al. N Engl J Med. 2022 Aug 25;387(8):704-714. doi: 10.1056/NEJMoa2201904. N Engl J Med. 2022. PMID: 36001711 Clinical Trial.
In the pooled analysis of the two trials, 5.2% of the participants in the ublituximab group and 5.9% in the teriflunomide group had worsening of disability at 12 weeks (hazard ratio, 0.84; 95% CI, 0.50 to 1.41; P = 0.51). ...Serious infections occurred in 5.0% in the ublit …
In the pooled analysis of the two trials, 5.2% of the participants in the ublituximab group and 5.9% in the teriflunomide group had w …
Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II.
Gärtner J, Hauser SL, Bar-Or A, Montalban X, Cohen JA, Cross AH, Deiva K, Ganjgahi H, Häring DA, Li B, Pingili R, Ramanathan K, Su W, Willi R, Kieseier B, Kappos L. Gärtner J, et al. Mult Scler. 2022 Sep;28(10):1562-1575. doi: 10.1177/13524585221078825. Epub 2022 Mar 10. Mult Scler. 2022. PMID: 35266417 Free PMC article. Clinical Trial.
BACKGROUND: In the phase III ASCLEPIOS I and II trials, participants with relapsing multiple sclerosis receiving ofatumumab had significantly better clinical and magnetic resonance imaging (MRI) outcomes than those receiving teriflunomide. OBJECTIVES: To assess the efficac …
BACKGROUND: In the phase III ASCLEPIOS I and II trials, participants with relapsing multiple sclerosis receiving ofatumumab had significantl …
Efficacy and safety of four-year ofatumumab treatment in relapsing multiple sclerosis: The ALITHIOS open-label extension.
Hauser SL, Zielman R, Das Gupta A, Xi J, Stoneman D, Karlsson G, Robertson D, Cohen JA, Kappos L. Hauser SL, et al. Mult Scler. 2023 Oct;29(11-12):1452-1464. doi: 10.1177/13524585231195346. Epub 2023 Sep 11. Mult Scler. 2023. PMID: 37691530 Free PMC article. Clinical Trial.
BACKGROUND: Ofatumumab has demonstrated superior efficacy and favorable safety for up to 2.5 years versus teriflunomide in relapsing multiple sclerosis (RMS). OBJECTIVE: Further characterize efficacy and safety of ofatumumab in RMS. METHODS: Efficacy set: patients randomiz …
BACKGROUND: Ofatumumab has demonstrated superior efficacy and favorable safety for up to 2.5 years versus teriflunomide in relapsing …
Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial.
Kappos L, Fox RJ, Burcklen M, Freedman MS, Havrdová EK, Hennessy B, Hohlfeld R, Lublin F, Montalban X, Pozzilli C, Scherz T, D'Ambrosio D, Linscheid P, Vaclavkova A, Pirozek-Lawniczek M, Kracker H, Sprenger T. Kappos L, et al. JAMA Neurol. 2021 May 1;78(5):558-567. doi: 10.1001/jamaneurol.2021.0405. JAMA Neurol. 2021. PMID: 33779698 Free PMC article. Clinical Trial.
IMPORTANCE: To our knowledge, the Oral Ponesimod Versus Teriflunomide In Relapsing Multiple Sclerosis (OPTIMUM) trial is the first phase 3 study comparing 2 oral disease-modifying therapies for relapsing multiple sclerosis (RMS). OBJECTIVE: To compare the efficacy of pones …
IMPORTANCE: To our knowledge, the Oral Ponesimod Versus Teriflunomide In Relapsing Multiple Sclerosis (OPTIMUM) trial is the first ph …
Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years.
Hauser SL, Cross AH, Winthrop K, Wiendl H, Nicholas J, Meuth SG, Giacomini PS, Saccà F, Mancione L, Zielman R, Bagger M, Das Gupta A, Häring DA, Jehl V, Kieseier BC, Pingili R, Stoneman D, Su W, Willi R, Kappos L. Hauser SL, et al. Mult Scler. 2022 Sep;28(10):1576-1590. doi: 10.1177/13524585221079731. Epub 2022 Mar 1. Mult Scler. 2022. PMID: 35229668 Free PMC article. Clinical Trial.
We analyzed cumulative data of continuous ofatumumab treatment and of patients newly switched from teriflunomide. RESULTS: The safety population had 1969 patients: 1292 continuously treated with ofatumumab (median time-at-risk 35.5 months, 3253 patient-years) and 677 newly …
We analyzed cumulative data of continuous ofatumumab treatment and of patients newly switched from teriflunomide. RESULTS: The safety …
Teriflunomide in pediatric patients with relapsing multiple sclerosis: Open-label extension of TERIKIDS.
Chitnis T, Banwell B, Kappos L, Arnold DL, Gücüyener K, Deiva K, Saubadu S, Hu W, Benamor M, Le-Halpere A, Truffinet P, Tardieu M. Chitnis T, et al. Mult Scler. 2024 Jun;30(7):833-842. doi: 10.1177/13524585241242050. Epub 2024 Apr 15. Mult Scler. 2024. PMID: 38619037 Free PMC article. Clinical Trial.
BACKGROUND: The double-blind TERIKIDS study demonstrated the efficacy and safety of teriflunomide. OBJECTIVE: To evaluate the efficacy, safety, and tolerability of continuous teriflunomide treatment in the TERIKIDS open-label extension. ...There was a trend toward r …
BACKGROUND: The double-blind TERIKIDS study demonstrated the efficacy and safety of teriflunomide. OBJECTIVE: To evaluate the efficac …
Safety and efficacy of evobrutinib in relapsing multiple sclerosis (evolutionRMS1 and evolutionRMS2): two multicentre, randomised, double-blind, active-controlled, phase 3 trials.
Montalban X, Vermersch P, Arnold DL, Bar-Or A, Cree BAC, Cross AH, Kubala Havrdova E, Kappos L, Stuve O, Wiendl H, Wolinsky JS, Dahlke F, Le Bolay C, Shen Loo L, Gopalakrishnan S, Hyvert Y, Javor A, Guehring H, Tenenbaum N, Tomic D; evolutionRMS investigators. Montalban X, et al. Lancet Neurol. 2024 Nov;23(11):1119-1132. doi: 10.1016/S1474-4422(24)00328-4. Epub 2024 Sep 19. Lancet Neurol. 2024. PMID: 39307151 Clinical Trial.
Serious TEAE incidence rates were higher with evobrutinib than teriflunomide (86 [7.5%] vs 64 [5.6%]). Liver enzyme elevations at least 5 upper limit of normal were more common with evobrutinib than with teriflunomide, particularly in the first 12 weeks (55 [5.0%] v …
Serious TEAE incidence rates were higher with evobrutinib than teriflunomide (86 [7.5%] vs 64 [5.6%]). Liver enzyme elevations at lea …
Long-term safety and efficacy of teriflunomide: Nine-year follow-up of the randomized TEMSO study.
O'Connor P, Comi G, Freedman MS, Miller AE, Kappos L, Bouchard JP, Lebrun-Frenay C, Mares J, Benamor M, Thangavelu K, Liang J, Truffinet P, Lawson VJ, Wolinsky JS; Teriflunomide Multiple Sclerosis Oral (TEMSO) Trial Group and the MRI-AC in Houston, Texas. O'Connor P, et al. Neurology. 2016 Mar 8;86(10):920-30. doi: 10.1212/WNL.0000000000002441. Epub 2016 Feb 10. Neurology. 2016. PMID: 26865517 Free PMC article. Clinical Trial.
METHODS: A total of 742 patients entered the extension. Teriflunomide-treated patients continued the original dose; those previously receiving placebo were randomized 1:1 to teriflunomide 14 mg or 7 mg. ...CLASSIFICATION OF EVIDENCE: This study provides Class III ev …
METHODS: A total of 742 patients entered the extension. Teriflunomide-treated patients continued the original dose; those previously …
64 results