Biologics for immunosuppression

Biologics for immunosuppression (often called "biologics", "biological therapy" or "biological drugs") are a class of immunosuppressive drugs which chemically are biopharmaceutical treatments.[1][2][3]

Biologics treat medical conditions where immunotherapy is effective.[1] Some conditions which biologics treat are rheumatic disorders[2] such as psoriatic arthritis,[1] ankylosing spondylitis and non-radiographic axial spondyloarthritis,[4] and inflammatory bowel disease.[5]

Example drugs of this type include adalimumab, certolizumab, etanercept, golimumab, infliximab, ixekizumab, belimumab, and ustekinumab.[1][6]

Medical uses
See also: Monoclonal antibody therapy

Biologics provide immunotherapy[1] and can function as disease-modifying antirheumatic drugs.[2]

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.[7]

For people with moderate to severe psoriatic arthritis, biologics can provide some relief of the symptoms,[1] 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.[7]

Biologics can treat inflammatory bowel disease. Classes of biologics typicaly used for inflammatory bowel disease include TNF inhibitors, and anti-CD28 antibodies.[5]

Contraindications

Biologics should be used after considering other less invasive treatments.[1] 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.[1]

Most biologics are injections so are not appropriate for use by someone with intense fear of needles.[1] A person with any infection should not use biologics.[1]

Other contraindications for biologics include cancer, certain neurologic disorders, being pregnant or breastfeeding, history of heart failure, or history of tuberculosis.[1]

Adverse effects

Common adverse effects of biologic administration are injection site reactions including erythema, pain, and itching.[8] Other adverse effects include headache, skin reactions, respiratory tract infection, and urinary tract infection.[1][3] Adverse effects may be class-dependent, and so switching to a biologic of another class may ameliorate those effects.[7]

Potential serious adverse effects include allergic reactions, liver damage, cancer, and serious infections including tuberculosis, pneumonia, staph infection, and fungal infection.[1][3]

Manufacturing
See also: Monoclonal antibody § Production

Genetically engineered cell cultures in pharmaceutical labs produce the biologics.[9]

History

Biologics are the second generation of biopharmaceutical products.[9] The first generation were the biopharmaceutical products which could be extracted from organisms without biotechnology from the Information Age.[9] Those first generation products include blood for transfusion, early insulin extracted from animals, and vaccines from eggs.[9]

When biologic drugs became available they led to significant changes in the management of various autoimmune diseases.[10]

Society and culture

Term

The term "biologic therapy" is nonspecific,[11] and can refer to any biopharmaceutical medication.[12] However, many sources use the term to refer to immunotherapy treatments.[1][2][3]

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.[13]

Example biologics

Biologics for immunosuppression include adalimumab, certolizumab, etanercept, golimumab, infliximab, ixekizumab, belimumab, and ustekinumab.[1]

Another related term, biosimilar, is a term for describing 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".[14]

Economics

Biologic drugs are expensive.[1] In the United States treatment with biologic drugs typically costs US$2,000-6,000 per month,[1] compared to US$12-600 per month for conventional (small-molecule) DMARDs.[15]

References
  1. "Biologic Medications for Psoriasis". Consumer Reports. August 2014. Retrieved 17 July 2017.
  2. Singh, JA; Christensen, R; Wells, GA; Suarez-Almazor, ME; Buchbinder, R; Lopez-Olivo, MA; Tanjong Ghogomu, E; Tugwell, P (7 October 2009). Singh, Jasvinder A. (ed.). "Biologics for rheumatoid arthritis: an overview of Cochrane reviews". The Cochrane Database of Systematic Reviews (4): CD007848. doi:10.1002/14651858.CD007848.pub2. PMID 19821440.
  3. Singh, JA; Wells, GA; Christensen, R; Tanjong Ghogomu, E; Maxwell, L; Macdonald, JK; Filippini, G; Skoetz, N; Francis, D; Lopes, LC; Guyatt, GH; Schmitt, J; La Mantia, L; Weberschock, T; Roos, JF; Siebert, H; Hershan, S; Lunn, MP; Tugwell, P; Buchbinder, R (16 February 2011). "Adverse effects of biologics: a network meta-analysis and Cochrane overview". The Cochrane Database of Systematic Reviews. 2016 (2): CD008794. doi:10.1002/14651858.CD008794.pub2. PMC 7173749. PMID 21328309.
  4. Ward, MM; Deodhar, A; Gensler, LS; Dubreuil, M; Yu, D; Khan, MA; Haroon, N; Borenstein, D; Wang, R; Biehl, A; Fang, MA; Louie, G; Majithia, V; Ng, B; Bigham, R; Pianin, M; Shah, AA; Sullivan, N; Turgunbaev, M; Oristaglio, J; Turner, A; Maksymowych, WP; Caplan, L (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. 71 (10): 1285–1299. doi:10.1002/acr.24025. PMC 6764857. PMID 31436026.
  5. D'Haens, G. (1 May 2007). "Risks and benefits of biologic therapy for inflammatory bowel diseases". Gut. 56 (5): 725–732. doi:10.1136/gut.2006.103564. PMC 1942157. PMID 17440187.
  6. Dubey, Ashok K.; Handu, Shailendra S.; Dubey, Suparna; Sharma, Prashant; Sharma, K. K.; Ahmed, Qazi M. (2011). "Belimumab: First targeted biological treatment for systemic lupus erythematosus". Journal of Pharmacology & Pharmacotherapeutics. 2 (4): 317–319. doi:10.4103/0976-500X.85930. ISSN 0976-500X. PMC 3198539. PMID 22025872.
  7. Tsai, YC; Tsai, TF (May 2020). "Switching biologics in psoriasis - practical guidance and evidence to support". Expert Review of Clinical Pharmacology. 13 (5): 493–503. doi:10.1080/17512433.2020.1767590. PMID 32394765. S2CID 218599646.
  8. Kim, PJ; Lansang, RP; Vender, R (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. 27 (4): 358–367. doi:10.1177/12034754231188444. PMC 10486173. PMID 37533141.
  9. Zimney, Ed (2 December 2008). "Understanding biologics: How they differ from drugs and why they cost more - Dr. Z's Medical Report". Everyday Health. Archived from the original on 13 August 2017. Retrieved 17 July 2017.
  10. Drosos, AA; Pelechas, E; Kaltsonoudis, E; Markatseli, TE; Voulgari, PV (June 2021). "Biologic Therapies and Autoimmune Phenomena". Mediterranean Journal of Rheumatology. 32 (2): 96–103. doi:10.31138/mjr.32.2.96. PMC 8369271. PMID 34447904.
  11. "What biological therapies are". www.cancerresearchuk.org. Cancer Research UK. 25 Nov 2014.
  12. Center for Biologics Evaluation and Research (5 August 2015). "What Are "Biologics" Questions and Answers". www.fda.gov. Retrieved 17 July 2017.
  13. "Biopharmaceutical". ScienceDaily. Retrieved 2018-12-07.
  14. Food and Drug Administration (27 August 2015). "Information for Consumers (Biosimilars)". www.fda.gov.
  15. Table 4, Cost Comparison Table for the Treatment of Plaque Psoriasis. Canadian Agency for Drugs and Technologies in Health. June 2019. Retrieved 16 October 2023.
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