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About REMICADE
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About REMICADE® (infliximab)

Updated on 15/03/2018

IMMUNOLOGY

REMICADE has over 18 years of experience of treating patients with immune-mediated diseases in the field of Rheumatology, Gastroenterology and Dermatology.

REMICADE indications over time1

REMICADE timeline

REMICADE therapeutic indications2

Rheumatoid arthritis

REMICADE, 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 anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate.
  • adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.

In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated (see section 5.1 of SmPC2).

Adult Crohn's disease

REMICADE is indicated for:

  • treatment of moderately to severely active Crohn's disease, in 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.
  • treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).

Paediatric Crohn's disease

REMICADE is indicated for treatment of severe, active Crohn's disease, in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. REMICADE has been studied only in combination with conventional immunosuppressive therapy.

Ulcerative colitis

REMICADE is indicated for treatment of moderately to severely active ulcerative colitis in 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.

Paediatric ulcerative colitis

REMICADE is indicated for treatment of severely active ulcerative colitis, in children and adolescents aged 6 to 17 years, 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

REMICADE is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.

Psoriatic arthritis

REMICADE is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.

REMICADE should be administered

  • in combination with methotrexate
  • or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated

REMICADE has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1 of SmPC2).

What is REMICADE?

REMICADE is a monoclonal antibody; it is a TNFα (Tumour Necrosis Factor–alpha) inhibitor that is indicated for the treatment of a range of immune-mediated inflammatory disorders.2

REMICADE is a prescription-only product. It is presented as powder (100 mg/vial) to be reconstituted with water, diluted with saline and thereafter administered via intravenous infusion.2

How does REMICADE Work?

REMICADE inhibits TNFα, thereby neutralising its biological activity.

18 years of Clinical Real World data for REMICADE

  • REMICADE has extensive patient experience, clinical and real world data
  • 8,700 clinical trial patients4 – 37
  • 2.6 m patients have been exposed worldwide38 - 46
  • Efficacy and safety profile established, with over 18 years of experience (depending on indication)1,2


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References

  1. European Commission Community Register Available at: http://ec.europa.eu/health/documents/community-register/html/h116.htm Accessed May 2017.
  2. REMICADE 100mg powder for concentrate for solution for infusion. Summary of Product Characteristics.
  3. Immunobiology: The Immune System in Health and Disease. 5th edition Janeway CA Jr, Travers P, Walport M, et al. New York: Garland Science 2001. Available at http://www.ncbi.nlm.nih.gov/books/NBK27155/ Accessed May 2016.
  4. Maini R, et al.Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet. 1999 Dec 4;354(9194):1932-9.
  5. St Clair EW, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum. 2004 Nov;50(11):3432-43.
  6. Rahman MU, et al. Double-blinded infliximab dose escalation in patients with rheumatoid arthritis. Ann Rheum Dis. 2007 Sep;66(9):1233-8.
  7. Fleischmann R, et al. ACR 2010. Abstract 420.
  8. Elliott MJ, et al. Treatment of rheumatoid arthritis with chimeric monoclonal antibodies to tumor necrosis factor alpha. Arthritis Rheum. 1993 Dec;36(12):1681-90.
  9. Elliott et al. Randomised double-blind comparison of chimeric monoclonal antibody to tumour necrosis factor ex (cA2) versus placebo in rheumatoid arthritis Lancet 1994; 344: 1105-10.
  10. Maini et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. ARTHRITIS & RHEUMATISM 1998: 41(9):1552-1563.
  11. Kavanaugh et al Chimeric anti-tumor necrosis factor-alpha monoclonal antibody treatment of patients with rheumatoid arthritis receiving methotrexate therapy. Journal of rheumatology.2000;27(4):841-50.
  12. Safety and Tolerability of a Rapid Infusion of REMICADE® (Infliximab) in the Treatment of Rheumatoid Arthritis R Isern; W Shergy; C Sanders; G Hughes; S Toder; G Keenan. EULAR 2001.
  13. Fleischmann RM, et al. Methotrexate dosage reduction in patients with rheumatoid arthritis beginning therapy with infliximab: the Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) trial. Curr Med Res Opin. 2005 Aug;21(8):1181-90.
  14. European Medicines Agency EPAR. http://www.ema.europa.eu/docs/en_GB/document _library/EPAR_Scientific_Discussion_/human /000240/WC500050885.pdf.
  15. van der Heijde D, et al. Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT). Arthritis Rheum. 2005 Feb;52(2):582-91.
  16. Sieper J, et al. EULAR 2012. Abstract THU0274.
  17. Antoni CE, et al. Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT). Arthritis Rheum. 2005 Apr;52(4):1227-36.
  18. Kavanaugh A, et al. Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial. Ann Rheum Dis. 2007 Apr;66(4):498-505.
  19. Baranauskaite A, et al. Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naive patients: the RESPOND study. Ann Rheum Dis. 2012 Apr;71(4):541-8.
  20. Targan et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. N Engl J Med. 1997;337(15):1029-35.
  21. Hanauer SB et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002;359(9317):1541-9.
  22. Sands BE, et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85.
  23. Colombel JF, et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95.
  24. Present et al. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999;340(18):1398-405.
  25. D’HAENS et al. Endoscopic and Histological Healing With Infliximab Anti–Tumor Necrosis Factor Antibodies in Crohn’s Disease: A European Multicenter Trial Gastroenterology. 1999;116:1029–1034.
  26. van Dullemen HM et al. Treatment of Crohn's disease with anti-tumor necrosis factor chimeric monoclonal antibody (cA2). Gastroenterology. 1995 Jul;109(1):129-35.
  27. Hyams J, et al. Induction and maintenance infliximab therapy for the treatment of moderate-to-severe Crohn's disease in children. Gastroenterology. 2007 Mar;132(3):863-73.
  28. Baldassano et al. Infliximab (REMICADE®) Therapy in the Treatment of Pediatric Crohn’s Disease. THE AMERICAN JOURNAL OF GASTROENTEROLOGY 2003; 98(4):833-838.
  29. Rutgeerts P, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76.
  30. Panccione, R et al. Gastroenterology.2011;140(5):S-134.
  31. Sands et al. Infliximab in the Treatment of Severe, Steroid-Refractory Ulcerative Colitis: A Pilot Study Inflammatory Bowel Diseases. 2001; 7(2):83-88.
  32. Hyams J, et al. Induction and maintenance therapy with infliximab for children with moderate to severe ulcerative colitis. Clin Gastroenterol Hepatol. 2012 Apr;10(4):391-9.e1.
  33. Reich K, et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet. 2005 Oct 15-21;366(9494):1367-74.
  34. Menter A, et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2007 Jan;56(1):31.e1-15.
  35. Gottlieb AB, et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2004 Oct;51(4):534-42.
  36. Barker J, et al. Efficacy and safety of infliximab vs. methotrexate in patients with moderate-to-severe plaque psoriasis: results of an open-label, active-controlled, randomized trial (RESTORE1). Br J Dermatol. 2011 Nov;165(5):1109-17.
  37. Gottlieb AB, et al. EADV FALL 2010; P530.
  38. MSD data on file [PSUR 27, February 2013.
  39. MSD data on file [PSUR 16, August 2007].
  40. MSD data on file [PSUR18, August 2008].
  41. MSD data on file [PSUR19, Feb 2009].
  42. MSD data on file [PSUR 22, Aug 2010].
  43. MSD data on file [PSUR 23, February 2011].
  44. MSD data on file [PSUR 25, February 2012].
  45. MSD data on file [PSUR, October 2015].
  46. MSD data on file [PSUR, October 2016].

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

MULT-1246521-0000 | Date of Preparation: March 2018