Biological response modifier

Medical uses

Biologics provide immunotherapy and can function as disease-modifying antirheumatic drugs.

Biologics can generally be grouped by their "class", that is, their specific mechanism of action and affected targets. Some classes are TNF inhibitors, anti-IL-17A antibodies, and IL-23 antibodies.

For people with moderate to severe psoriatic arthritis, biologics can provide some relief of the symptoms, and even slow down or halt the progression of the disease. Classes of biologics typically used for psoriatic arthritis include TNF inhibitors, anti-IL17-A antibodies, IL-23 antibodies, and those that act on both IL-12 and IL-23.

Biologics can treat inflammatory bowel disease. Classes of biologics typically used for inflammatory bowel disease include TNF inhibitors, and anti-CD28 antibodies.

Contraindications

Biologics are generally used after considering other less invasive treatments. Before using biologics to treat psoriasis, treatment with topical moisturizers or steroids, or light therapy may provide relief. Other drugs which may provide relief include acitretin, ciclosporin, and methotrexate, but since these drugs have their own major side effects, doctors and patients should discuss whether to try one of these or a biologic first.

Most biologics are injections so are not appropriate for use by someone with intense fear of needles. A person with any infection should not use biologics.

Other contraindications for biologics include cancer, certain neurologic disorders, being pregnant or breastfeeding, history of heart failure, or history of tuberculosis.

Adverse effects

Common adverse effects of biologic administration are injection site reactions including redness, pain, and itching. Other adverse effects include headache, skin reactions, respiratory tract infection, and urinary tract infection. Adverse effects may be class-dependent, and so switching to a biologic of another class may ameliorate those effects.

Potential serious adverse effects include allergic reactions, liver damage, cancer, and serious infections including tuberculosis, pneumonia, staph infection, and fungal infection.

Patients with systemic lupus erythematosus (SLE) who are treated with the standard of care, including biologic response modifiers, experience a higher risk of mortality and opportunistic infection compared to the general population.

Examples

Biopharmaceuticals

Biologics for immunosuppression include adalimumab, certolizumab, etanercept, golimumab, infliximab, ixekizumab, belimumab, and ustekinumab.

Natural BRMs

Extracts from some medicinal mushrooms are natural biological response modifiers.

Manufacturing==

Genetically engineered cell cultures in pharmaceutical labs produce the biologics.

History

Biologics are the second generation of biopharmaceutical products. The first generation were the biopharmaceutical products which could be extracted from organisms without biotechnology from the Information Age, such as blood for transfusion, early insulin extracted from animals, and vaccines from eggs.

When biologic drugs became available they led to significant changes in the management of various autoimmune diseases.

Society and culture

Term

The term "biologic therapy" is nonspecific, and can refer to any biopharmaceutical medication. However, many sources use the term to refer to immunotherapy treatments.

The explanation for this is that while "biologic" or "biopharmaceutical" refers to the chemical composition of medications which might be used to treat a range of medical conditions, when the term "biologic" became popular, many biologic medications available provided immunosuppression.

Legal status

Biosimilar is a term used to describe a biopharmaceutical product which seems so close in composition and effect to another that they are functionally identical, analogous to generic drugs. In this context, some publications describe "biologics" as "biosimilars".

Economics

Biologic drugs are expensive. In the United States treatment with biologic drugs typically costs –6,000 per month, compared to –600 per month for conventional (small-molecule) DMARDs.

References

• Deepak A. Rao; Le, Tao; Bhushan, Vikas. First Aid for the USMLE Step 1 2008 (First Aid for the Usmle Step 1). McGraw-Hill Medical. .

References

1. "Definition of Biological response modifiers". MedicineNet.com.
2. "Biological Response Modifiers (BRM)".
3. (October 2019). "2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis.". Arthritis Care & Research.
4. (August 2014). "Biologic Medications for Psoriasis".
5. (7 October 2009). "Biologics for rheumatoid arthritis: an overview of Cochrane reviews.". The Cochrane Database of Systematic Reviews.
6. (May 2020). "Switching biologics in psoriasis - practical guidance and evidence to support.". Expert Review of Clinical Pharmacology.
7. (July 2023). "A Systematic Review and Meta-Analysis of Injection Site Reactions in Randomized-Controlled Trials of Biologic Injections.". Journal of Cutaneous Medicine and Surgery.
8. (16 February 2011). "Adverse effects of biologics: a network meta-analysis and Cochrane overview.". The Cochrane Database of Systematic Reviews.
9. Shamliyan, Tatyana A.. (July 2017). "Additional Improvements in Clinical Response From Adjuvant Biologic Response Modifiers in Adults With Moderate to Severe Systemic Lupus Erythematosus Despite Immunosuppressive Agents: A Systematic Review and Meta-analysis". Clinical Therapeutics.
10. "Enbrel- etanercept solution Enbrel- etanercept kit".
11. "Safety Update on TNF- α Antagonists: Infliximab and Etanercept". U.S. [[Food and Drug Administration]] (FDA).
12. (2015). "Persistence of Autoreactive IgA-Secreting B Cells Despite Multiple Immunosuppressive Medications Including Rituximab". JAMA Dermatol.
13. (October 2022). "Infectious Complications of Targeted Therapies in Children with Leukemias and Lymphomas". Cancers.
14. (June 2003). "Interstitial pneumonitis related to rituximab therapy". The New England Journal of Medicine.
15. (10 November 2006). "Reports of Bowel Obstruction and Perforation with RITUXAN (rituximab)". Roche Canada.
16. (6 November 2019). "Rituxan- rituximab injection, solution".
17. "Rituximab". The American Society of Health-System Pharmacists.
18. (March 2002). "Cardiac dysfunction in the trastuzumab clinical trials experience". Journal of Clinical Oncology.
19. Tzianabos AO. (2000). "Polysaccharide immunomodulators as therapeutic agents: structural aspects and biologic function.". Clin Microbiol Rev.
20. (2 December 2008). "Understanding biologics: How they differ from drugs and why they cost more - Dr. Z's Medical Report".
21. (June 2021). "Biologic Therapies and Autoimmune Phenomena.". Mediterranean Journal of Rheumatology.
22. (25 Nov 2014). "What biological therapies are". [[Cancer Research UK]].
23. (5 August 2015). "What Are "Biologics" Questions and Answers".
24. "Biopharmaceutical".
25. (27 August 2015). "Information for Consumers (Biosimilars)".
26. (June 2019). "Table 4, Cost Comparison Table for the Treatment of Plaque Psoriasis". Canadian Agency for Drugs and Technologies in Health.