CelltrionHealthcare

The full therapeutic indications for Remsima® are as follows:

■ Rheumatoid arthritis
Remsima®, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement of physical function for:
• adult patients with active arthritis when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate;
• adult patients with severe, active, and progressive arthritis not previously treated with methotrexate or other DMARDs. It was observed that Remsima® slowed down the progression of joint damage in this group of patients at the time of the X-ray evaluation.

■ Adult Crohn’s disease
Remsima® is indicated for:
• the treatment of moderately to severely active Crohn’s disease for adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant or who are intolerant to, or have medical contraindications for, such therapies; and
• the treatment of fistulising, active Crohn’s disease for adult patients who have not responded despite a full and adequate course of therapy with conventional treatments such as antibiotics, drainage, and immunosuppressive therapy.

■ Pediatric Crohn’s disease (in children and adolescents ages 6 to 17)
Remsima® is indicated for the treatment of severe, active Crohn’s disease in children and adolescents ages 6 to 17, who have not responded to conventional therapies, including corticosteroid, immunomodulatory, and primary nutrition therapies; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.

■ Ulcerative colitis
Remsima® is indicated for the treatment of moderately to severely active ulcerative colitis for adult patients who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

■ Pediatric ulcerative colitis (for children and adolescents ages 6 to 17)
Remsima® is indicated for the treatment of severely active ulcerative colitis in children and adolescents ages 6 to 17, who have had an inadequate response to conventional therapy, including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.

■ Ankylosing spondylitis
Remsima® is indicated for the treatment of severe, active ankylosing spondylitis for adult patients who have responded inadequately to conventional therapy with an increase in serologic markers associated with inflammation.

■ Psoriatic arthritis
Remsima® is indicated for the treatment of active and progressive psoriatic arthritis for adult patients when the response to previous DMARD therapy has been inadequate.
Remsima® should be administered:
• in combination with methotrexate; or
• by itself for patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
• It is effective in improving the physical function of patients with psoriatic arthritis. An X-ray evaluation shows that it can also slow down the progression of peripheral joint damage of those with symmetrical polyarthritis.

■ Psoriasis
Remsima® is indicated for the treatment of moderate to severe plaque psoriasis for adult patients who failed to respond to, who have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate, or psoralen ultra-violet A (PUVA).

Remsima® was approved based on the results of the PLANETRA and PLANETAS trials, which compared its efficacy and safety with the reference infliximab in rheumatoid arthritis and ankylosing spondylitis patients, respectively.

The PLANETRA trial was a phase III, randomized, double-blind, multicenter, multinational, parallel-group study in 606 patients with rheumatoid arthritis (RA). After 30 weeks of treatment, Remsima® was comparable to the reference infliximab in symptom reduction, with around 60% of patients responding to the treatment with either medicine. Remsima® also demonstrated a similar safety profile to that of the reference infliximab.

The PLANETAS trial was a group study involving 250 patients with ankylosing spondylitis (AS) in which Remsima® was compared with reference infliximab. Remsima® was found to maintain the levels of the active substance in the body that were comparable to the reference infliximab and equivalent pharmacokinetic profiles. Remsima® was well tolerated, with an efficacy and safety profile similar to that of the reference infliximab up to week 30.

Remsima® has been approved for sale in about 110 countries across the world(As of third quarter of 2019).

Remsima® and Inflectra® refer to the same biosimilar infliximab developed and manufactured by Celltrion Inc. but with different brand names. Inflectra® is the brand name used in the U.S. market by Celltrion Healthcare’s global partner Pfizer.