What are biologics (biological therapies)?

From the Guidelines

Biologics are a crucial treatment option for patients with moderate to severe psoriasis, offering effective therapy for those who do not respond to conventional treatments, as recommended by the British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017 1. Biologics are advanced medications made from living organisms or their components, designed to target specific pathways in the immune system. They include monoclonal antibodies (like adalimumab, infliximab), fusion proteins (etanercept), and cytokines that treat conditions such as rheumatoid arthritis, psoriasis, inflammatory bowel disease, and certain cancers.

Key Characteristics of Biologics

• Large, complex proteins administered via injection or infusion
• Precisely target inflammatory mediators rather than broadly suppressing the immune system
• Offer effective treatment for patients who don't respond to conventional therapies
• Carry risks including infection susceptibility, injection site reactions, and potential development of neutralizing antibodies, requiring careful monitoring during treatment

Common Biologics Used in Psoriasis Treatment

• TNF inhibitors: Humira (adalimumab) typically given as 40mg subcutaneous injections every two weeks, Enbrel (etanercept) as 50mg weekly injections, and Remicade (infliximab) as intravenous infusions dosed by weight
• IL-17 inhibitors: Cosentyx
• IL-12/23 inhibitors: Stelara
• B-cell depleting agents: Rituxan The British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017 1 provide evidence-based recommendations on the use of biologic therapies in adults, children, and young people for the treatment of psoriasis, considering the specific needs of people with psoriasis and psoriatic arthritis.

Important Considerations

• Biologic therapies have now been in use for over 10 years, and with accrued patient-year exposure and clinical experience, many areas that were covered in previous versions of the guideline are now part of the summary of product characteristics (SPC) and/or routine care
• The guideline assumes that prescribers cross-reference a drug’s SPC to inform clinical decision making for individual patients
• Where relevant, this guidance applies to biosimilars (similar biological medical products), subject to recommendations given within the BAD position statement and the European Medicines Agency guidelines 1.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Definition and Types of Biologics

• Biologics are a diverse group of drugs that act directly on the immune system, including cytokines and monoclonal antibodies 2
• They can be genetically engineered versions of naturally occurring substances or novel compounds used for the treatment of cancer and non-oncology diagnoses 2

Efficacy of Biologics in Rheumatoid Arthritis

• Biologic agents have revolutionized the treatment of rheumatoid arthritis (RA), with significant improvements in symptoms and disease progression 3, 4
• Studies have shown that biologics such as adalimumab, etanercept, and infliximab are effective in reducing symptoms and slowing radiographic joint damage in RA patients 3, 4
• Upadacitinib, a JAK1-selective inhibitor, has also been shown to be effective in improving signs, symptoms, and physical function in RA patients with an inadequate response to methotrexate 5

Safety and Management of Biologics

• Biologics can increase the risk of serious infections, and their use should be carefully considered in patients with a history of infections or immunosuppression 4, 5
• The use of biologics in surgery, vaccinations, and cancer requires careful management, with recommendations to withhold biologic therapy for certain periods before and after these events 6
• Nursing management of biologics includes monitoring for side effects, managing infusion reactions, and educating patients on self-administration and storage of biologics 2

Economic Evaluation of Biologics

• The cost-effectiveness of biologics in RA treatment has been evaluated, with results showing that biologics can be cost-effective in certain scenarios, such as when used as last active therapy 4
• The incremental cost-effectiveness ratio (ICER) of biologics varies depending on the specific agent and patient population, with etanercept appearing to be the most cost-effective option in some studies 4