Inflectra® | Safety Profile & Efficacy

Rheumatoid Arthritis

Inflectra®, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:

• Adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate2.
• Adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs2.

PLANETRA and PLANETAS

These were the pivotal studies that gained Inflectra®/CT-P13* (infliximab) a licence as the first approved biosimilar infliximab1,18,19.

They demonstrated comparable efficacy and safety profile to Remicade® in rigorous studies in RA and AS1,3

PLANETRA18,20 was conducted in pateints with diagnosed rheumatoid arthritis.

Click here to read the safety and efficacy results for PLANETRA in RA

PLANETAS19,21 was conducted in patients with diagnosed ankylosing spondylitis.

Click here to read the safety and efficacy results for PLANETAS in AS

Via extrapolation, Inflectra®/CT-P13* is licensed for all of the same clinical indications as Remicade®§1-3.

Click here to read about extrapolation

 

Prescribing Information 

Inflectra® Summary of Product Characteristics   |   Legal Category: POM  Basic NHS Price: 1 vial £377.66

*CT-P13 is marketed under different brand names including INFLECTRA® and REMSIMA®.
§EMA guidelines state that “Extrapolation of clinical efficacy and safety data to other indications of the reference mAb, not specifically studied during the clinical development of the biosimilar mAb, is possible based on the results of the overall evidence provided from the comparability exercise and with adequate justification.”1,3.

EMA, European Medicines Agency; mAb, Monoclonal antibody

 

PP-IFA-GBR-0320. December 2018