- Biologics are a category of medications that treat axial spondyloarthritis (axSpA) by targeting specific proteins involved in inflammation.
- There are several classes of biologics for axSpA that work in different ways.
- Biologics may work quickly to improve axSpA symptoms and can slow the progression of irreversible joint damage.
- Some biologics are approved by the U.S. Food and Drug Administration (FDA) and/or the European Medicines Agency (EMA) to treat ankylosing spondylitis only, while others are approved to treat both ankylosing spondylitis and nonradiographic axial spondyloarthritis, when joint damage is not yet visible in X-rays.
Many classes of drugs have been developed to help manage symptoms and flares of spondyloarthritis. Biologic drugs are believed to slow joint damage by reducing autoimmune inflammation in axSpA.
Biologics are drugs made of proteins, sugars, or nucleic acids.1 Unlike other drugs that are chemically synthesized, biologics are derived from living organisms. Examples of biologics include vaccines, gene therapy, and monoclonal antibodies used to treat cancer and arthritis. Biologics that are disease-modifying antirheumatic drugs (DMARDs) can be used to treat rheumatic diseases such as axSpA.
Types of Spondyloarthritis
It’s helpful to review the terminology around types of spondyloarthritis before getting into the specifics of how they are treated with biologics. Spondyloarthritis refers to a category of inflammatory diseases that primarily affect the spine and other joints.2 Types of spondyloarthritis include psoriatic arthritis, arthritis associated with inflammatory bowel disease, and axial spondyloarthritis.3
Axial spondyloarthritis specifically affects the joints that connect the pelvis and lower spine.4
There are two subtypes under the umbrella of axSpA: nonradiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS).5 Changes to joints in nr-axSpA cannot be seen in X-rays, while changes in AS are apparent in X-rays. Every case of axSpA begins as nonradiographic. Between 10 percent and 40 percent of nr-axSpA cases progress to become radiographic within 10 years.6
Your treatment options differ depending on which subtype of axSpA you have. While some biologics have been approved by the U.S. Food and Drug Administration (FDA) and/or the European Medicines Agency (EMA) to treat AS only, other biologics are approved to treat both AS and nr-axSpA.
Read more about types and symptoms of spondyloarthritis.
To understand how biologic DMARDs are used to treat axSpA, it is important to know a little more about the immune system, inflammation, and a class of biologics known as monoclonal antibodies.
What Are Monoclonal Antibodies?
Antibodies are proteins that form a vital part of the immune system. They are produced by specialized immune cells, known as B cells, to fight bacterial or viral infections.7 The human body is capable of making almost 100 billion different types of B cells, and each type of B cell produces only one type of antibody.8 Each antibody is a protein that recognizes and interacts with a very specific target.
B cells can also be genetically altered in a lab to produce specific antibodies that will attach to a target protein. These are known as monoclonal antibodies because they are produced from one type of B cell.9
Every antibody made by that B cell will have the same properties. Researchers have designed monoclonal antibodies to target specific proteins on the outside of immune cells, cancer cells, and other abnormal cells associated with disease.
Biologics for Axial Spondyloarthritis
There are several categories of biologics with different targets. Currently, tumor necrosis factor alpha (TNF-ɑ) inhibitors and interleukin-17A (IL-17A) blockers are the only categories of biologic DMARDs approved to treat axSpA. Doctors may recommend biologics in cases where nonsteroidal anti-inflammatory drugs (NSAIDs) did not work.10 Biologics can be used on their own or in combination with traditional DMARDs, like Azulfidine (Sulfasalazine) and Methotrexate, to treat axSpA.11
How Effective Are Biologics for AxSpA?
Traditionally, NSAIDs such as Advil (Ibuprofen), Aleve (Naproxen), and Celebrex (Celecoxib) are used to treat symptoms of axSpA, temporarily managing pain and inflammation.22 However, new biologic DMARDs work by targeting the cause of inflammation at its source, slowing disease progression and irreversible joint damage.
While axSpA cannot be cured, treatment can often stop or reduce inflammation to the lowest levels possible in order to relieve symptoms and slow further joint damage. If axSpA continues to progress, it can lead to permanent joint damage and disability. DMARDs like biologics can control active axSpA and reduce inflammation, reducing symptoms and improving quality of life.
What To Expect When Starting Biologics
All biologics are given as injections — either subcutaneous (under the skin), intramuscular (into muscle), or as intravenous (IV) infusions.25 Biologics cannot be taken by mouth because they would be broken down in the stomach and intestines before being absorbed into the bloodstream.
Before you start biologic therapy, you may undergo some screening tests to make sure you are not at risk from any underlying conditions. Screening often includes tests for tuberculosis and hepatitis B and C.26 You may be monitored regularly for these or other conditions during treatment with biologics to make sure you are not at risk for developing any complications.
Side Effects of Biologics
In most cases, the benefits of using approved drugs to treat a condition outweigh the possible side effects you may experience. If you notice side effects, talk to your doctor about how to manage them and ask whether they may fade over time.
Common side effects associated with biologic drugs include:27
- Redness, pain, swelling, and itching at the injection site
- Increased risk for infections, because the drugs work by suppressing the immune system
- Infusion reactions, which are similar to allergic reactions (pain, swelling, flushing, headache, etc.)
Always listen to your body. If you experience any of these new symptoms after using biologic drugs, contact your doctor right away:27
- Fever, sweat, or chills
- Shortness of breath
- Chest pain
- Vision problems
- Painful rash or sores
- Diarrhea or stomach pain
- Bleeding or bruising easily
These are all signs of an infection or a more serious condition that should be addressed immediately.
Finding Support for Spondyloarthritis
You are not alone in living with spondyloarthritis. When you join my MySpondylitisTeam, you gain a community of more than 58,000 people who know what it’s like to live with inflammatory arthritis. More than 2,800 members report treating their axSpA with biologics.
If you are concerned you may have spondyloarthritis, this doctor discussion guide can help you start a conversation with your health care provider.
- Center for Biologics Evaluation and Research. (2018). What Are "Biologics" Questions and Answers. U.S. Food and Drug Administration. https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers.
- Arthritis Foundation. (2020). Spondyloarthritis. https://www.arthritis.org/diseases/spondyloarthritis.
- Mcgonagle, D. G., Mcinnes, I. B., Kirkham, B. W., Sherlock, J., & Moots, R. (2019). The role of IL-17A in axial spondyloarthritis and psoriatic arthritis: recent advances and controversies. Annals of the Rheumatic Diseases, 78(9), 1167–1178. https://doi.org/10.1136/annrheumdis-2019-215356.
- Poddubnyy, D. (2013). Axial spondyloarthritis: is there a treatment of choice?. Therapeutic Advances in Musculoskeletal Disease, 5(1), 45–54. https://doi.org/10.1177/1759720X12468658.
- Lubrano, E., Perrotta, F. M., Manara, M., D’Angelo, S., Ramonda, R., Punzi, L., & Marchesoni, A. (2020). Improvement of Function and Its Determinants in a Group of Axial Spondyloarthritis Patients Treated with TNF Inhibitors: A Real-Life Study. Rheumatology and Therapy, 7(2), 301–310. https://doi.org/10.1007/s40744-020-00197-5.
- Protopopov, M. & Poddubnyy, D. (2018). Radiographic progression in non-radiographic axial spondyloarthritis. Expert Review of Clinical Immunology, 14(6), 525–533. https://doi.org/10.1080/1744666X.2018.1477591.
- Graham, B.J. (2019). Antibody. National Human Genome Research Institute. https://www.genome.gov/genetics-glossary/Antibody.
- Glanville, J., Zhai, W., Berka, J., Telman, D., Huerta, G., Mehta, G. R., Ni, I., Mei, L., Sundar, P. D., Day, G. M., Cox, D., Rajpal, A., & Pons, J. (2009). Precise determination of the diversity of a combinatorial antibody library gives insight into the human immunoglobulin repertoire. Proceedings of the National Academy of Sciences of the United States of America, 106(48), 20216–20221. https://doi.org/10.1073/pnas.0909775106.
- Shepard, H. M., Phillips, G. L., Thanos, C. D., & Feldmann, M. (2017). Developments in therapy with monoclonal antibodies and related proteins. Clinical Medicine, 17(3), 220–232. https://doi.org/10.7861/clinmedicine.17-3-220.
- Bruner, V., Atteno, M., Spanò, A., Scarpa, R., & Peluso, R. (2014). Biological therapies for spondyloarthritis. Therapeutic Advances in Musculoskeletal Disease, 6(3), 92–101. https://doi.org/10.1177/1759720X14535512.
- Huston, K. (2019). Spondyloarthritis. ACR Patient Info. https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Spondyloarthritis.
- Mease P. J. (2007). Adalimumab in the treatment of arthritis. Therapeutics and Clinical Risk Management, 3(1), 133–148. https://doi.org/10.2147/tcrm.2007.3.1.133.
- Guillot X., Prati C., Sondag M., & Wendling D. (2017) Etanercept for treating axial spondyloarthritis, Expert Opinion on Biological Therapy, 17:9, 1173-1181. https://doi.org/10.1080/14712598.2017.1347156.
- Van den Bosch, F., Baeten, D., Kruithof, E., De Keyser, F., Mielants, H., & Veys, E. M. (2001). Treatment of active spondyloarthropathy with infliximab, the chimeric monoclonal antibody to tumour necrosis factor α. Annals of the Rheumatic Diseases, 60(33). https://ard.bmj.com/content/60/suppl_3/iii33.
- Palazzi, C., D'angelo, S., Gilio, M., Leccese, P., Padula, A., & Olivieri, I. (2017). Golimumab for the treatment of axial spondyloarthritis. Expert Opinion on Biological Therapy, 17(1), 129–133. https://doi.org/10.1080/14712598.2017.1256387.
- Desmarais, J., Beier, S., & Deodhar, A. (2016). Certolizumab pegol for treating axial spondyloarthritis. Expert Opinion on Biological Therapy, 16(8), 1059–1064. https://doi.org/10.1080/14712598.2016.1205581.
- Gower, T. (2020). Enthesitis and PsA. Arthritis Foundation. https://www.arthritis.org/health-wellness/about-arthritis/related-conditions/physical-effects/enthesitis-and-psa.
- Ligi, A., Clark, L., & Althoff, E. (2020). Novartis Cosentyx® receives FDA approval for new indication to treat active non-radiographic axial spondyloarthritis. Novartis. https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-new-indication-treat-active-non-radiographic-axial-spondyloarthritis.
- Eli Lilly and Company. (2020). Non-Radiographic Axial Spondyloarthritis Medication: Taltz® (ixekizumab). https://www.taltz.com/nr-axspa.
- U.S. Food and Drug Administration. (2018). Cosentyx Prescribing Information. (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125504s013lbl.pdf.
- Eli Lilly and Company. (2020). Mechanism of Action: IL17A & IgG4: Taltz (ixekizumab). (2020). https://www.taltz.com/hcp/moa-il17a-igg4.
- Kroon, F. P., Burg, L. R. V. D., Ramiro, S., Landewé, R. B., Buchbinder, R., Falzon, L., & Heijde, D. V. D. (2015). Non-steroidal anti-inflammatory drugs (NSAIDs) for axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis). Cochrane Database of Systematic Reviews, (7). https://doi.org/10.1002/14651858.cd010952.pub2.
- Rodriguez, R.V., & Poddubnyy, D. (2017). Tumor necrosis factor-α (TNFα) inhibitors in the treatment of nonradiographic axial spondyloarthritis: current evidence and place in therapy. Therapeutic Advances in Musculoskeletal Disease, 9(8), 197–210. https://doi.org/10.1177/1759720X17706454.
- Joszt, L. (2020). Secukinumab Approved to Treat Nonradiographic Axial Spondyloarthritis Based on Safety, Efficacy of PREVENT. American Journal of Managed Care. https://www.ajmc.com/view/secukinumab-approved-to-treat-nonradiographic-axial-spondyloarthritis-based-on-safety-efficacy-of-prevent.
- Anselmo, A. C., Gokarn, Y., & Mitragotri, S. (2018). Non-invasive delivery strategies for biologics. Nature Reviews Drug Discovery, 18(1), 19–40. https://doi.org/10.1038/nrd.2018.183.
- Schmajuk, G. (2019). Few patients starting biologics, DMARDs screened for HBV, HCV. Healio. https://www.healio.com/news/rheumatology/20191112/few-patients-starting-biologics-dmards-screened-for-hbv-hcv.
- Arthritis Foundation. (2020) Benefits and Risks. Biologics. https://www.arthritis.org/drug-guide/biologics/biologics.