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Richard Melsheimer

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Recent Articles
1.
Branco A, Argolo W, Santos N, Hernandez G, Kakehasi A, Sobrado C, et al.
Arq Gastroenterol . 2024 May; 61:e23149. PMID: 38775584
Background: Monoclonal antibodies have proven efficacy in the management of several conditions and infliximab (IFX) is one of the most important drugs of the class. Some recent data have shown...
2.
OHalloran J, Ko E, Anstrom K, Kedar E, McCarthy M, Panettieri Jr R, et al.
JAMA . 2023 Jul; 330(4):328-339. PMID: 37428480
Importance: Immune dysregulation contributes to poorer outcomes in COVID-19. Objective: To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia. Design, Setting, And...
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OHalloran J, Kedar E, Anstrom K, McCarthy M, Ko E, Nunez P, et al.
medRxiv . 2022 Sep; PMID: 36172138
Background: Immune dysregulation contributes to poorer outcomes in severe Covid-19. Immunomodulators targeting various pathways have improved outcomes. We investigated whether infliximab provides benefit over standard of care. Methods: We conducted...
5.
Lin I, Melsheimer R, Bhak R, Lefebvre P, DerSarkissian M, Emond B, et al.
Curr Med Res Opin . 2022 Feb; 38(4):613-627. PMID: 35125053
Objective: To compare treatment patterns of United States (US) veterans stable on innovator infliximab (IFX) who switched to an IFX biosimilar (switchers) or remained on innovator IFX (continuers). Methods: US...
6.
Afzali A, Furtner D, Melsheimer R, Molloy P
Adv Ther . 2021 Mar; 38(5):2077-2093. PMID: 33745111
In the USA, an interchangeability designation provides biosimilar sponsors with a pathway for achieving what is standard for small-molecule generics: pharmacy-level auto-substitution for an innovator. No other major health authority...
7.
Fitzgerald T, Melsheimer R, Lafeuille M, Lefebvre P, Morrison L, Woodruff K, et al.
Biologics . 2021 Jan; 15:1-15. PMID: 33442230
Objective: To compare switching and discontinuation patterns of patients stable on originator infliximab (IFX) who switched to an IFX biosimilar (switchers) or remained on originator IFX (continuers) in the United...
8.
Melsheimer R, Geldhof A, Apaolaza I, Schaible T
Biologics . 2019 Aug; 13:139-178. PMID: 31440029
On August 24, 1998, Remicade (infliximab), the first tumor necrosis factor-α (TNF) inhibitor, received its initial marketing approval from the US Food and Drug Administration for the treatment of Crohn's...
9.
Philip G, Cornillie F, Adedokun J, Melsheimer R, Rutgeerts P, Colombel J, et al.
J Crohns Colitis . 2019 Mar; 13(10):1257-1264. PMID: 30847474
Background And Aims: In nonresponders to golimumab induction for ulcerative colitis, we assessed clinical response rates and golimumab serum concentrations when the 100-mg dose was used early in the course...
10.
Melsheimer R, Calmann M, DeRitis A, Philip V, Van Gog F, Doolittle L, et al.
BioDrugs . 2018 Aug; 32(5):405-414. PMID: 30143982
Biologics are produced from living organisms in complex, multi-stage manufacturing processes and contain inherent variability, which must be understood and controlled during manufacturing to avoid unexpected changes in key quality...