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The autoimmune disorders are a protean group of acquired diseases in which genetic factors also play a role. They have in common widespread immunologic alterations and often share features of generalized inflammation.

Because of overlapping clinical features, differentiation among autoimmune diseases may be challenging, particularly in their early stages. These illnesses share certain clinical features, and differentiation among them is often difficult. Common findings include synovitis, pleuritis, myocarditis, endocarditis, pericarditis, peritonitis, vasculitis, myositis, skin rash, and nephritis. Laboratory tests may reveal Coombs-positive hemolytic anemia, thrombocytopenia, leukopenia, immunoglobulin excesses or deficiencies, antinuclear antibodies, rheumatoid factors, cryoglobulins, false-positive serologic tests for syphilis, other antiphospholipid antibodies, elevated muscle enzymes, and hypocomplementemia.

Some of the laboratory abnormalities found in autoimmune diseases (eg, false-positive serologic tests for syphilis, rheumatoid factor) occur in asymptomatic individuals. These changes may also be demonstrated in certain asymptomatic relatives of patients with connective tissue diseases, in older persons, in patients using certain medications, and in patients with chronic infectious diseases.

Biologic agents, such as TNF-alpha inhibitors (eg, adalimumab, infliximab), monoclonal antibodies (rituximab), and many more, have revolutionized the treatment of rheumatic disease. These medications are unique in pharmacology because they are made from living sources such as bacteria, yeast, or animal cells. Due to the mechanism of production and complexity of the large molecules, there are miniscule and clinically insignificant variations in each batch that is produced.

Biosimilars have great potential to be less expensive alternatives to biologic agents and contain the active ingredient of their reference product. However, they cannot precisely be called “generics” because exact replication is impossible. The FDA approval process for biosimilars requires the demonstration of equal safety and efficacy to the reference product. As of early 2024, there are 45 FDA-approved biosimilars in the United States. Due to the lower cost of these drugs, many insurance companies are requiring them as first-line therapy. The cost-saving potential with biosimilars is an exciting prospect given the high, and at times unaffordable, price of biologics. However, controversies exist regarding changing therapy for patients who are stable on a biologic to a biosimilar given the nuances of these molecules.

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Ascef  BO  et al. Therapeutic equivalence of biosimilar and reference biologic drugs in rheumatoid arthritis: a systematic review and meta-analysis. JAMA Netw Open. 2023;6:e2315872.
[PubMed: 37234004]  
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Gall  S  et al. Patient knowledge about biosimilars and satisfaction with the education provided by rheumatologists or nurse specialists in a biosimilar multiswitch scenario – the perception study. Semin Arthritis Rheum. 2022;57:152119.
[PubMed: 36341778]  

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