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. 2019 Dec;33(6):689-694.
doi: 10.1111/fcp.12480. Epub 2019 May 29.

Is TNF inhibitor exposure a risk factor for amyotrophic lateral sclerosis?

Nadine Petitpain  1 , David Devos  2   3 , Haleh Bagheri  4 , Fanny Rocher  5 , Aurore Gouraud  6 , Kamel Masmoudi  7 , Antoine Coquerel  8
Affiliations

Is TNF inhibitor exposure a risk factor for amyotrophic lateral sclerosis?

Nadine Petitpain et al. Fundam Clin Pharmacol. 2019 Dec.

Abstract

TNFα modulation has been reported to be either beneficial or detrimental in amyotrophic lateral sclerosis (ALS) and therefore appears as a key issue. We analysed the relationship between TNFα inhibitor (TNFi) exposure and ALS. We performed descriptive analysis of ALS reports in patients treated with TNFi, registered in the French Pharmacovigilance Database (FPvD) and disproportionality analyses by the 'case'/'non-case' method in FPvD and worldwide database (Vigibase® ). The 8 retrieved ALS cases from the FPvD were 5 with limb-onset and 3 with bulbar-onset forms, in patients aged 43-75 years old, mainly treated for inflammatory rheumatism. The time to onset of the first symptoms ranged from 12 to 108 months, and the cumulative TNFi exposure before the diagnosis ranged from 12 to 120 months. TNFi was discontinued and thereafter survival ranged between 12 and 20 months. Disproportionality analyses showed significant associations between TNFi exposure and ALS in the FPvD and Vigibase® (160 ALS cases), regardless comparators. A putative association between TNFi and ALS must be interpreted cautiously, but TNFi could act as a predisposing or risk factor. TNFi should therefore be avoided in patients with a known risk of ALS and discontinued in the case of neurological signs of ALS.

Keywords: TNF inhibitors; amyotrophic lateral sclerosis; pharmacovigilance.

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References

    1. Brown R.H., Al-Chalabi A. Amyotrophic lateral sclerosis. N. Engl. J. Med. (2017) 377 162-172.
    1. Loustau V., Foltz V., Poulain C., Rozenberg S., Bruneteau G. Diagnosis of amyotrophic lateral sclerosis in a patient treated with TNFα blockers for ankylosing spondylitis: fortuitus association or new side effect of TNFα blockers? Joint Bone Spine (2009) 76 213-214.
    1. Khalid S.I., Ampie L., Kelly R., Ladha S.S., Dardis C. Immune modulation in the treatment of amyotrophic lateral sclerosis: a review of clinical trials. Front. Neurol. (2017) 8 11.
    1. Rothman K.J., Lanes S., Sacks S.T. The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol. Drug Saf. (2004) 13 519-523.
    1. Saliba L., Moulis G., Abou Taam M. et al. Tumor necrosis factor inhibitors added to nonbiological immunosuppressants vs. nonbiological immunosuppressants alone: a different signal of cancer risk according to the condition. A disproportionality analysis in a nationwide pharmacovigilance database. Fundam. Clin. Pharmacol. (2016) 30 162-171.

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