Chronic Diarrhea Associated with High Teriflunomide Blood Concentration

Duquette, André; Frenette, Anne Julie; Doré, Monique

doi:10.1007/s40744-016-0025-3

Cited by 13 publications

(9 citation statements)

References 18 publications

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“…In addition, both celiac disease as well as autoimmune thyroiditis and a host of other autoimmune conditions are associated with lymphocytic colitis. 4 Although there have been cases of lymphocytic colitis associated with leflunomide use, 1 it has not been associated with teriflunomide to date.…”

Section: Discussionmentioning

confidence: 99%

“…Teriflunomide is an active form of leflunomide, a drug that is used to treat rheumatoid arthritis. 1 Previous studies have reported gastrointestinal symptoms as a potential adverse effect of teriflunomide, but these symptoms are usually self-limiting and will be alleviated when the drug is eliminated, either through time or washout with cholestyramine. 2…”

Section: Introductionmentioning

confidence: 99%

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Lymphocytic colitis in the setting of teriflunomide use for relapsing multiple sclerosis

Son

McEwan

Ubaidat³

et al. 2020

Mult Scler

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Teriflunomide is an oral monotherapy used to treat relapsing multiple sclerosis. Although teriflunomide may be associated with gastrointestinal symptoms, these events are mild and self-limiting. We present a 39-year-old female who developed severe diarrhea and lost 20 pounds within 3 weeks of starting teriflunomide. Despite discontinuing teriflunomide and undergoing cholestyramine washout, her symptoms persisted. Celiac disease on genetic testing was positive, but no anti-transglutaminase and anti-endomysial antibodies were detected. She underwent colonoscopy and biopsy was consistent with lymphocytic colitis. Remission was achieved within days of starting budenoside. Our case describes a rare, but serious, gastrointestinal adverse event of teriflunomide.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Lymphocytic colitis in the setting of teriflunomide use for relapsing multiple sclerosis

Son

McEwan

Ubaidat³

et al. 2020

Mult Scler

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“…Finally, Duquette et al . also described a case of histologically acute and subacute colitis related to high teriflunomide blood concentration after 2 years of treatment 5 …”

Section: Figurementioning

confidence: 98%

“…A recent manuscript proposed the possibility of teriflunomide promoting a lymphocytic colitis pattern [4]. Finally, Duquette et al also described a case of histologically acute and subacute colitis related to high teriflunomide blood concentration after 2 years of treatment [5].…”

Section: Item Of Correspondencementioning

confidence: 99%

Teriflunomide, a potential novel cause of chronic active colitis

et al. 2020

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“…While leflunomide is widely used in treating RA, either as a monotherapy or in combination with methotrexate [18], the class of DHODH inhibitors to which both leflunomide and teriflunomide belong have been the subject of numerous safety concerns since their approval by the FDA. Postmarket surveillance includes reports of a variety of drug-related adverse reactions, including elevated liver enzymes and hepatotoxicity, peripheral neuropathy, vasculitis, hypertension, alopecia, pruritus, nausea, and diarrhea [16,[19][20][21][22][23][24][25][26][27][28]. In one prospective study evaluating leflunomide treatment in 136 RA patients, 65% of patients experienced at least that inhibitors of DHODH show immunomodulatory activity, which is most pronounced on T cells [3][4][5][6][7][8], with T helper (Th) 1 and Th17 cells acting as important contributors to the inflammatory processes of RA [9].…”

Section: Key Pointsmentioning

confidence: 99%

The Selective Oral Immunomodulator Vidofludimus in Patients with Active Rheumatoid Arthritis: Safety Results from the COMPONENT Study

Muehler¹,

Kohlhof²,

Groeppel³

et al. 2019

Drugs R D

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Introduction The dihydroorotate dehydrogenase (DHODH) inhibitors leflunomide and teriflunomide are immunomodulatory agents approved to treat rheumatoid arthritis (RA) and multiple sclerosis, respectively, and are actively being investigated as therapeutic agents for other immune-related diseases; however, both structurally related compounds have a number of potentially serious adverse effects. Vidofludimus, a new selective second-generation DHODH inhibitor, is chemically distinct from leflunomide/teriflunomide and appears to exhibit a distinct safety profile. Objective The aim of the COMPONENT study was to assess the efficacy, safety, and pharmacokinetics of vidofludimus in the treatment of patients with active RA on a background therapy of methotrexate. This report focuses solely on the safety results of the COMPONENT trial. Methods Patients received once-daily oral vidofludimus (N = 122) or placebo (N = 119) along with their standard of care methotrexate treatment for 13 weeks. Efficacy endpoints were assessed. Safety parameters were monitored throughout treatment and at follow-up. Plasma concentrations of vidofludimus were measured. Results The primary efficacy endpoint, American College of Rheumatology 20 (ACR 20) responder rate at 13 weeks, demonstrated numerical superiority in the treatment group compared with placebo; however, it did not reach statistical significance. Nonetheless, the COMPONENT study yielded important safety and pharmacokinetic data that could provide important information regarding the use of vidofludimus in other clinical trials, not only for RA but also for other autoimmune diseases. A safety profile for vidofludimus similar to placebo was obtained in this RA patient population. This includes similar rates of the adverse events of diarrhea, alopecia, neutropenia, and elevated liver enzymes, all of which are known drug-related adverse events reported for leflunomide and teriflunomide. A potential pharmacokinetic interaction between vidofludimus and methotrexate was observed. Conclusions Vidofludimus demonstrated a positive safety profile, making it a promising candidate for the treatment of a variety of immune-related diseases. Trial Registrations ClinicalTrials.gov identifier: NCT01010581.

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Chronic Diarrhea Associated with High Teriflunomide Blood Concentration

Cited by 13 publications

References 18 publications

Lymphocytic colitis in the setting of teriflunomide use for relapsing multiple sclerosis

Lymphocytic colitis in the setting of teriflunomide use for relapsing multiple sclerosis

Teriflunomide, a potential novel cause of chronic active colitis

The Selective Oral Immunomodulator Vidofludimus in Patients with Active Rheumatoid Arthritis: Safety Results from the COMPONENT Study

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