March 31, 2019 – The American Food and Drug Administration (FDA) has just approved drugs for two rather problematic neurological conditions, namely multiple sclerosis (i.e., Cladribine (Mavenclad)) and non-radiographic axial spondyloarthritis (i.e., Certolizumab pegol (Cimzia)), offering patients with these conditions urgently need additional therapy options. FDA approves new oral treatment for multiple sclerosis
The FDA approved Cladribine (Mavenclad) tablets to treat relapsing forms of multiple sclerosis (MS ) in adults, to include relapsing-remitting disease and active secondary progressive disease. Cladribine (Mavenclad) is not recommended for MS patients with clinically isolated syndrome. Because of its safety profile, the use of Mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS.
MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communications between the brain and other parts of the body. Most people experience their first symptoms of MS between the ages of 20 and 40. MS is among the most common causes of neurological disability in young adults and occurs more frequently in women than in men.
For most people, MS starts with a relapsing-remitting course, in which episodes of worsening function (relapses) are followed by recovery periods (remissions). These remissions may not be complete and may leave patients with some degree of residual disability. Many, but not all, patients with MS experience some degree of persistent disability that gradually worsens over time. In some patients, disability may progress independent of relapses, a process termed secondary progressive multiple sclerosis (SPMS). In the first few years of this process, many patients continue to experience relapses, a phase of the disease described as active SPMS. Active SPMS is one of the relapsing forms of MS, and drugs approved for the treatment of relapsing forms of MS can be used to treat active SPMS. The efficacy of Cladribine (Mavenclad) was shown in a clinical trial in 1,326 patients with relapsing forms of MS who had least one relapse in the previous 12 months. Cladribine (Mavenclad) significantly decreased the number of relapses experienced by these patients compared to placebo. Cladribine (Mavenclad) also reduced the progression of disability compared to placebo.
The FDA also approved Certolizumab pegol (Cimzia) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), Nr-axSpA is a type of inflammatory arthritis that causes inflammation in the spine and other symptoms. There is no visible damage seen on x-rays, so it is referred to as non-radiographic. The efficacy of Certolizumab pegol (Cimzia) for the treatment of nr-axSpA was studied in a randomized clinical trial in 317 adult patients with nr-axSpA with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) levels and/or sacroiliitis (inflammation of the sacroiliac joints) on MRI. The trial measured the improvement response on the Ankylosing Spondylitis Disease Activity Score, a composite scoring system that assesses disease activity including patient-reported outcomes and CRP levels. Responses were greater for patients treated with Certolizumab pegol (Cimzia) compared to patients treated with placebo. The overall safety profile observed in the Certolizumab pegol (Cimzia) treatment group was consistent with the known safety profile of Certolizumab pegol (Cimzia). Certolizumab pegol (Cimzia) was originally approved in 2008 and is also indicated for adult patients with Crohn’s disease, moderate-to-severe rheumatoid arthritis, active ankylosing spondylitis (AS) and moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Both drugs come with some very serious adverse effects which may be fatal in some circumstances, however. Thus, Cladribine (Mavenclad) must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Cladribine (Mavenclad) has a Boxed Warning for an increased risk of malignancy and fetal harm. Cladribine (Mavenclad) is not to be used in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, health care professionals should evaluate the benefits and risks of the use of Cladribine (Mavenclad) on an individual patient basis. Health care professionals should follow standard cancer screening guidelines in patients treated with Cladribine (Mavenclad). The drug should not be used in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception during treatment and for six months after the course of therapy because of the potential for fetal harm. Cladribine (Mavenclad) should be stopped if the patient becomes pregnant. Other warnings include the risk of decreased lymphocyte (white blood cell) counts; lymphocyte counts should be monitored before, during and after treatment. Cladribine (Mavenclad) may increase the risk of infections; health care professionals should screen patients for infections and treatment with Cladribine (Mavenclad) should be delayed if necessary. Cladribine (Mavenclad) may cause hematologic toxicity and bone marrow suppression so health care professionals should measure a patient’s complete blood counts before, during and after therapy. The drug has been associated with graft-versus-host-disease following blood transfusions with non-irradiated blood. Cladribine (Mavenclad) may cause liver injury and treatment should be interrupted or discontinued, as appropriate, if clinically significant liver injury is suspected.
Similarly, the prescribing information for Certolizumab pegol (Cimzia) includes a Boxed Warning to advise health care professionals and patients about the increased risk of serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis (infection in the blood steam), invasive fungal infections (such as histoplasmosis, an infection that affects the lungs), and other infections. Certolizumab pegol (Cimzia) should be discontinued if a patient develops a serious infection or sepsis. Health care providers are advised to perform testing for latent TB and, if positive, to start treatment for TB prior to starting Certolizumab pegol (Cimzia). All patients should be monitored for active TB during treatment, even if the initial latent TB test is negative. The Boxed Warning also advises that lymphoma (cancer in blood cells) and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, of which Certolizumab pegol (Cimzia) is a member. Certolizumab pegol (Cimzia) is not indicated for use in pediatric patients. Certolizumab pegol (Cimzia) must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.
Ph.D.; Professor in Pharmacology and Toxicology.
Senior expert in theragenomic and personalized medicine and individualized drug safety.
Senior expert in pharmaco- and toxicogenetics.
Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.
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