Cimzia® - Rheumatoid arthritis

Europe

In Europe, Cimzia®, in combination with methotrexate (MTX), is indicated for

the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate, has been inadequate. Cimzia® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

Cimzia® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

USA

Cimzia® (certolizumab pegol) is a tumor necrosis factor (TNF) blocker indicated in the US for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

Warning: serious infections and malignancy

See full prescribing information for complete boxed warning.

Increased risk of serious infections leading to hospitalisation or death including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (5.1)

Cimzia should be discontinued if a patient develops a serious infection or sepsis (5.1)

Perform test for latent TB; if positive, start treatment for TB prior to starting Cimzia (5.1)

Monitor all patients for active TB during treatment, even if initial latent TB test is negative (5.1)

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which Cimzia is a member (5.2). Cimzia is not indicated for use in pediatric patients (8.4).