Always consult your health care provider about the appropriate treatment and dosage for you. Cimzia works by inhibiting tumor necrosis factor-alpha. TNF-alpha is a cytokine, or protein, involved in systemic inflammation. Results from three Phase 3 clinical trials showed significant improvement in psoriasis symptoms through 48 weeks in adults who received Cimzia in one of two doses, mg or mg, compared with the placebo.
Overall, improvement was greater for people who took mg, which could mean that the larger dose may be more effective. Health care providers are advised to perform testing for latent TB and, if positive, to start treatment for TB prior to starting 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 Cimzia is a member. Cimzia is not indicated for use in pediatric patients.
Patients have frequently presented with disseminated rather than localized disease. Treatment with CIMZIA should not be initiated in patients with an active infection, including clinically important localized infections. Patients who develop a new infection during treatment with CIMZIA should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated.
Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic. During CIMZIA studies of psoriasis, malignancies excluding non-melanoma skin cancer were observed corresponding to an incidence rate of 0. This is approximately 2-fold higher than expected in the general population. Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma.
The potential role of TNF blocker therapy in the development of malignancies is not known. Most of the patients were receiving concomitant immunosuppressants. Cases of acute and chronic leukemia have been reported with TNF-blocker use.
Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk approximately 2-fold than the general population for developing leukemia. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer. Symptoms compatible with hypersensitivity reactions, including angioedema, anaphylactoid reaction, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following CIMZIA administration.
Some cases have been fatal. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with CIMZIA. Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia e. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection e. An increased risk of serious infections has been seen in clinical trials of other TNF blocking agents used in combination with anakinra or abatacept.
Formal drug interaction studies have not been performed with rituximab or natalizumab; however, because of the nature of the adverse events seen with these combinations with TNF blocker therapy, similar toxicities may also result from the use of CIMZIA in these combinations. Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Arthritis Care Res Hoboken.
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