Humira, Enbrel, Similar Drugs May Increase Risks of Inflammatory Central Nervous System Events: Study

Side effects of Humira, Enbrel or other similar rheumatoid arthritis drugs may increase the risk of developing central nervous system conditions, such as optic neuritis and multiple sclerosis, according to the findings of new research.

In a study published this week in the medical journal JAMA Neurology, researchers from the Mayo Clinic found that individuals taking medications that are part of a class of drugs known as tumor necrosis factor (TNF) inhibitors had a three-fold risk of developing central nervous system (CNS) events, including multiple sclerosis.

TNF inhibitors are common therapies for certain autoimmune diseases, including rheumatoid arthritis, juvenile arthritis, psoriatic arthritis, ulcertaitve colitis, Chrohn’s disease and others. Some of the best selling drugs in the U.S. are part of this class, including Humira, Enbrel, Remicade, Cimzia and Simponi, generating sales that are projected to reach more than $40 billion a year by 2026.

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A link between TNF inhibitor exposure and inflammatory CNS has been observed in the past, but was poorly understood. Therefore, researchers set out to investigate the link and potential side effects associated with the medications.

Researchers conducted a case-controlled study involving 212 patients with inflammatory CNS events. Patients were treated at three Mayo Clinic locations in Rochester, Minnesota; Scottsdale, Arizona; and Jacksonville, Florida between January 1, 2003, and February 20, 2019.

Patients were included if they had a diagnosed autoimmune disease and were prescribed TNF inhibitors for rheumatoid arthritis, psoriasis, Crohn disease, and ulcerative colitis and matched with a control.

According to the findings, those who took TNF inhibitors had three times the risk of developing a CNS event. However, if the patient had the autoimmune disease rheumatoid arthritis, their risk increased to five-fold.

Taking TNF inhibitors was linked to an increased risk of an inflammatory CNS event. Patients in both the autoimmune disease group and the control group developed CNS events if they were taking the TNF inhibitor. Roughly 60% of patients in the autoimmune group and 40% in the control group developed a CNS event.

The data indicates the association was similar for both inflammatory demyelinating and non-demyelinating central nervous system events.

The body makes a substance called tumor necrosis factor and keeps it at a steady level, but when a person has autoimmune disease the body stops regulating it. This can lead to inflammation, pain, swelling or feeling ill.

TNF drug are designed to help stop inflammation and contain antibodies made in a lab from human or animal tissue. They are injected into the body to help block inflammation.

CNS events which occurred after taking drugs like Humira, included multiple sclerosis, optic neuritis, transverse myelitis, and neuromyelitis optica spectrum disorder. There were also reports of non-demyelinating CNS events like neurosarcoidosis and CNS vasculitis.

Prior studies have shown drugs like Humira were linked to increased risk of nerve damage to the eye, known as peripheral neuropathy. Another study, published by the Institute for Safe Medication Practices, indicated drugs like Humira and Enbrel caused more injuries to patients than any other drug in 2014.

Researchers hypothesize TNF inhibitors may worsen an immune response that is already abnormal, thus triggering a CNS event in patients with certain types of autoimmune diseases.

The study does not prove a direct cause and effect, but simply strengthens a link that was already seen. It may be that some autoimmune diseases are more severe and taking TNF inhibitors can lead to this result.

“In this study population, TNF inhibitor exposure in patients with autoimmune diseases appeared to be associated with an increased risk of both inflammatory demyelinating and nondemyelinating CNS events,” the researchers wrote. “Further research is needed to explore whether this association indicates de novo inflammation or exacerbation of already aberrant inflammatory pathways.”

3 Comments

  • BrandyDecember 1, 2022 at 12:21 pm

    I was on Humira for Crohn's disease and over 19 months started having chest pains, fatigue, numbness in my arms, muscle myalgia, rashes, and shortness of breath. I eventually lost my ability to walk and had severe mental disturbances and suicidal thoughts. Finally, a doctor diagnosed my Humira as the problem. I'm still in shock that the prescribing doctor did not recognize this adverse reaction an[Show More]I was on Humira for Crohn's disease and over 19 months started having chest pains, fatigue, numbness in my arms, muscle myalgia, rashes, and shortness of breath. I eventually lost my ability to walk and had severe mental disturbances and suicidal thoughts. Finally, a doctor diagnosed my Humira as the problem. I'm still in shock that the prescribing doctor did not recognize this adverse reaction and over a year later, I'm still rehabbing and have been told much of the damage to my body may be permanent. I started a podcast and a blog to try and help people going through this and to keep researching and bringing to light what these TNF inhibitors can do to you.

  • CrystalNovember 7, 2022 at 4:11 pm

    I am so sorry about your husband. I have been having most of the same problems that you've had since 2020 and the more I complained about crippling pain , tiredness, my mind not functioning properly, weakness, sore throat all the time , low grade fever and depression no one would listen and the doctors deamed crazy and refuse to treat me . I am being sent to one and another doctor. Now am be[Show More]I am so sorry about your husband. I have been having most of the same problems that you've had since 2020 and the more I complained about crippling pain , tiredness, my mind not functioning properly, weakness, sore throat all the time , low grade fever and depression no one would listen and the doctors deamed crazy and refuse to treat me . I am being sent to one and another doctor. Now am being told that a doctor wrote something about me in my file and they refuse to see me and I have no were to go , have no money . I know this isn't all in my head ; can someone help me . I've lost my life over these problems.

  • LindaAugust 6, 2022 at 1:45 pm

    My now 55 year-old husband has suffered with psoriasis since his twenties. It became uncomfortable for him personally (he was a coach and the kids would ask him what is that?" which was embarrassing for him and prompted him to receive treatment. Below is a chronological outline of what has happened since he began treatment: • was treated for psoriasis by his dermatologist back in 2012 startin[Show More]My now 55 year-old husband has suffered with psoriasis since his twenties. It became uncomfortable for him personally (he was a coach and the kids would ask him what is that?" which was embarrassing for him and prompted him to receive treatment. Below is a chronological outline of what has happened since he began treatment: • was treated for psoriasis by his dermatologist back in 2012 starting first with methotrexate which he took intermittently. • Summer 2013 started to take bi-monthly injections of Enbrel. • Summer 2016 started daily Otezla pills. • Spring 2017, diagnosed and treated for right eye cataract • Spring 2018, started on injections of Humira, off in winter due to Headaches, short temper, forgetfulness, fainted summer 2018; fainted fall 2018 at end of Bills game. ********************************Possible Diagnosis of MS******************************* • 1st Quarter of 2019, Diagnosis confirmed by Sacred Heart. This neurologist said the “spots” were not in the typical place he normally sees MS. Diagnosed relapsing/remitting MS. No other confirming tests were done other than an MRI of the brain. • Spring 2019, started on Gilenya which caused drastic weight loss • Summer 2019, saw USF Neurology, stopped Gilenya, prescribed Tecfidera • First quarter 2020, had to go off Tecfidera because of increased lymphocyte levels. • Diagnosed with kidney cancer which was treated with resection (partial nephrectomy) only. No chemo or radiation needed. • Prescribed Aubagio summer of 2020; Off Aubagio Summer of 2021 • Started Tysabri Fall 2021, diarrhea for 6 weeks. Now he experiences difficulty walking with the need for cane/walker, lose of balance, steady downhill progression, loss of consortium, depression, as well as other issues. We have gone to our internist, as well as a RA specialist, and no one can say why his condition has declined to this point. We now believe that the medication he was treated with for psoriasis caused this decline. Can you help?

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