Position statement on patient safety and site of service for biologics released by ACR

The ACR strongly supports the use of biologic agents as necessary treatments for rheumatic diseases. Biologics are highly effective for many diseases; however, their molecular structure,size, manufacturing, and storage, as well as their potential to cause serious adverse events,complicates delivery to patients. As a result, all biologics are considered complex medications by the ACR.

Due to their molecular structures, biologic drugs are administered via SC or IV routes. In addition, the tremendous heterogeneity of patients and the diversity of autoimmune conditions treated with biologics multiplies the variety of responses and side effects associated with these medicines, necessitating oversight by highly trained, specialized physicians to ensure their safe and effective administration. The ACR promotes the highest quality guidelines and best practices for treatment with biologics.

All classes of biologics used in autoimmune diseases have the potential to cause serious adverse events. Adverse events associated with biologics include, but are not limited to, injection site reactions, infusion reactions, exacerbation of heart failure, cytopenias, infections (including lethal tuberculosis and fungal infections), increased risk of skin cancer, psoriasis, demyelinating diseases (such as multiple sclerosis), the development of drug induced systemic lupus erythematosus, anaphylaxis and even death. Serious infections affect 2-5% of patients per year of exposure. Proper screening for occult infections and other comorbidities is required before biologics are prescribed and each time administration occurs. In addition, ongoing expert monitoring for any new or developing conditions is necessary to minimize the potential for harm.

Adverse drug reactions associated with biologics occur in up to 30% of patients in clinical trials.Although injection site reactions caused by SC biologics are generally easily managed, infusion reactions associated with IV biologics are often more serious. These reactions range in severity from a mild rash and myalgia to hypertension, shortness of breath, headaches, and even life-threatening anaphylaxis, and can occur during or after the infusion.

Infusion reactions must be promptly evaluated and treated. For a mild reaction, the infusion rate can often be slowed potentially allowing the patient to complete the infusion. Moderate reactions require cessation of the infusion and either oral or IV medications to prevent clinical decline. Severe reactions can involve multiple organ systems and lead to respiratory and cardiovascular collapse. These medical emergencies require immediate therapy with medications such as epinephrine and IV glucocorticoids. Such interventions are often beyond the scope of home health providers and delays waiting for emergency services further jeopardize patients' lives. Experienced providers, available on site, are most capable of decidine whether it is safe to continue therapy in the setting of mild reactions and providing prompt treatment for moderate or severe reactions.