Case Study Examines Biosimilar for Crohn Disease Treatment

A patient with Crohn disease (CD) developed chronic inflammatory demyelinating polyneuropathy (CIDP) after being prescribed the biosimilar infliximab-dyyp (Inflectra; Pfizer), a tumor necrosis factor-α inhibitor (TNFi), according to the authors of a recently published case report in ACG Case Reports Journal. The patient’s symptoms improved when he was taken off the TNFi and given intravenous (IV) steroid injections and plasma exchange.

“Owing to the temporal relationship between the biosimilar infusions and the onset of symptoms, improvement after discontinuation, and both clinical and endoscopic remission of CD, it was suspected that [infliximab-dyyp] may be related to his presentation of CIDP,” the study authors wrote in the paper.

Investigators noted that CIPD is an autoimmune disease of the peripheral nervous system. The condition leads to progressive symmetrical polyradiculoneuropathy—proximal and distal weakness and sensory disfunction across the extremities. Inflammatory bowel disease (IBD), which includes CD and ulcerative colitis, and TNFis may be rare and independent risk factors for CIPD, according to the study authors.

TNFis are one of the main classes of treatments for IBD, rheumatoid arthritis, psoriasis, and other autoimmune disease. Common types of the drug include infliximab, adalimumab, and etanercept.

The patient in the case study is aged 67 years with a history of heavy tobacco use, nephrolithiasis, and monoclonal gammopathy of undetermined significance (MGUS). He was hospitalized for progressive bilateral motor and sensory deficits in the upper and lower extremities 9 months after his CD diagnosis. He was subsequently treated with 5 mg/kg of infliximab-dyyp every 8 weeks.

The patients then developed paresthesias in the distal upper, lower extremities, and trunk, with the paresthesias eventually worsening. The patient lost his grip strength and his ability to independently walk, rendering him to a wheelchair. After receiving a series of physical examinations and a neural biopsy—the latter showing signs of albuminocytologic dissociation— he was diagnosed with CIPD.

His strength began to return when taken off infliximab-dyyp and was given IV steroid injections and biweekly plasma exchange, which he continued to take in the outpatient setting. Although IBD and MGUS are considered risk factors for CIDP, they were not suggested to cause his sudden illness.

The patients is in clinical remission but continues to have some residual effects.

“Neurological symptoms often recur, and patients require treatment with steroids, intravenous immunoglobulin (IVIg), or plasma exchange. Despite adequate treatment, some patients continue to have a relapsing and remitting disease,” the study authors wrote in the article.

CIPD affects 2.81 in every 100,000 people. Neurological symptoms can start between 2 weeks and 32 months after beginning a TNFi regimen.

TNFIs are associated with demyelination in the associated with demyelination in the central nervous system (CNS), i.e., multiple sclerosis, and peripheral nervous system (PNS), i.e., CIPD. However, neurologic adverse events occur nearly 4-times more often with CNS compared to PNS at 19.8% compared to 5.1%, respectively.

“Patients should be closely monitored for the development of peripheral neuropathies while receiving treatment with TNFis because CIDP is known to arise at any time during treatment,” the study authors wrote in the report.

Reference

Larson J, Twohig P, Hutchins K. Chronic Inflammatory Demyelinating Polyneuropathy After Therapy With Infliximab Biosimilar. ACG Case Rep J. 2023. doi: 10.14309/crj.0000000000000993