Autoimmune diseases induced by biological agents. A review of 12,731 cases (BIOGEAS Registry)

ABSTRACT

Introduction: Biological drugs are therapies designed to target a specific molecule of the immune system that have been linked with the development of autoimmune diseases.

Areas covered: The BIOGEAS Registry currently collects information about nearly 13,000 reported cases of autoimmune diseases developed in patients exposed to biologics, including more than 50 different systemic and organ-specific autoimmune disorders, of which psoriasis (n=6375), inflammatory bowel disease (n=845), demyelinating CNS disease (n=803), interstitial lung disease (n=519) and lupus (n=369) were the most frequently reported. The main biologics involved were anti-TNF agents in 9133 cases (adalimumab in 4154, infliximab in 3078 and etanercept in 1681), immune checkpoint inhibitors in 913 (ipilimumab in 524 and nivolumab in 225), B-cell targeted therapies in 741 (rituximab in 678), and growth factor inhibitors in 549 cases (bevacizumab in 544). Even though targeting a particular immune molecule may be associated with an excellent clinical response in most patients, an unexpected autoimmune disease may arise in around 8 out of 10,000 exposed patients.

Expert opinion: Following the increased use of biologics, the number and diversity of induced autoimmune diseases is increasing exponentially. Management of these disorders will be an increasing clinical challenge in the daily practice in the next years.

KEYWORDS:

• Autoimmune disease
• anti-TNF agents
• rituximab
• immune checkpoint inhibitors
• growth factor inhibitors
• cancer
• big data
• drug-induced event

Article highlights

• Nearly 13,000 cases of autoimmune disorders are reported in patients exposed to biological therapies.

• These disorders are reported overwhelmingly in patients with rheumatic diseases, cancer and IBD.

• There are more than 50 different biologic-induced systemic and organ-specific autoimmune disorders.

• Psoriasis, IBD, CNS demyelinating diseases, ILD and lupus were the most frequent induced autoimmune diseases

• The pharmacological scenario is highly heterogeneous with more than 30 different biological drugs involved pertaining to 8 different biologics groups

• The etiopathogenesis of these induced autoimmune diseases is unknown.

• A multidisciplinary workout is essential for managing the expected growing number of biological-induced autoimmune diseases.

This box summarizes key points contained in the article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

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Funding

This paper was not funded.