In years there has not been a treatment drug for rheumatoid arthritis. The FDA on March 28th finally gave approval for Cimzia (certolizumab pegol) injection for the treatment of nr-axSpA– inflammatory arthritis found in adults. This first approval of Cimzia is a fulfilling shot for patients suffering from nr-axSpA.
Cimzia
Nr-axSpA is a form of chronic arthritis that causes pain in the spine going all down. The pain can persist for up to three months consecutively. The condition affects joints and bones at the base of the spinal cord and pelvis. When the disease attacks all these parts they become inflamed.
Inflammatory arthritis
Unlike pain caused by physical injuries and accidents, this kind of inflammatory causes chronic pain followed by brief relief. These episodes of interchanging pain are referred to as ‘flares’. The back pain tends to get worse during inactivity- usually at night and mornings and gets better as the body engages in physical activity.
Clinical Trials
Cimzia first applied for a license to the FDA in 2006. Over the years it has evolved and has come so far. Its efficacy for the treatment of inflammatory arthritis was studied in a clinical trial; 317 adults suffering from nr-axSpA. Inflammation signs were indicated by increased levels of C-reactive proteins (CRP) and inflamed sacroiliac joints as indicated on MRI.
The trial monitored improvement responses on disease activity scores using a system that does an assessment on the disease activity and patient outcomes and CRP levels. Responses were compared between patients treated with a placebo and those treated with Cimzia. Cimzia patients had a greater response. The overall Cimzia safety profile was consistent among patients.
Risks and Warning Guide
Upon prescription, Cimzia includes warning information to advise patients and healthcare professionals of the implications of the drug. Risks include infections that may lead to hospitalization, Tuberculosis (TB), fungal infections, infection of the bloodstream (sepsis), and other infections which may lead to death. Although different patients react differently, any serious infections are a sign that Cimzia treatment should be discontinued immediately.
The warning also informs that lymphoma (cancer traces in the blood) and other fatal malignancies have been reported in teenagers and children patients under treatment of tumor necrosis blockers (TNF). Although Cimzia is a member of TNF it is not recommended for pediatric patients.
Implications of Cimzia Treatment
Before starting treatment, doctors are advised to conduct tests for latent TB in patients. If positive they should treat the TB first before starting on Cimzia treatment. All patients on Cimzia should be monitored throughout the treatment in case they develop TB, even if they initially tested negative for latent TB.
Cimzia Approval Evolution
Cimzia was initially approved in 2008 for Crohn’s disease in adult patients. In May 2009 it was approved for adults suffering from rheumatoid arthritis both severe and moderate cases. In 2013 it was approved for active Psoriatic arthritis in September and in October active Ankylosing Spondylitis in adult patients. In May 2018 the FDA approved Cimzia for Plaque Psoriasis.
References
Cimzia (certolizumab pegol) FDA Approval History – Drugs.com. (2019). Retrieved from https://www.drugs.com/history/cimzia.html
FDA approves treatment for patients with a type of inflammatory arthritis. (2019). Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634671.htm
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