Infliximab (IFX) – What is known about it

Infliximab aka  Remicade, Remsima, Inflectra has been cited in the immediate prior posts and is likely a good example because it has been heavily used — including for:

Effectiveness:

“the medications as 26% effective for abatacept, 24% for adalimumab, 28% for etanercept, and 23% for infliximab [for Crohn’s disease] .. Infliximab had highest cost per effectively treated patient.” [2015]

Safety Warnings from FDA was increased significantly in 2015. Full details from FDA

So what are the risks if you use it? A PubMed search returned over 3000 articles dealing with adverse effects.

  • “There is still paucity [insufficient information] of systematic and controlled data on the risk, prevention, and management of infusion reactions to infliximab” [2015]
  • “Infliximab caused liver injury in 8.3% of treated patients” [2015]
    • “Drug-induced liver injury from initial dose of infliximab.”[2015]
  • “10~20 % of patients was Remicade-resistant.” [2014]
    • “primary-non response” 22% [2014]
    • “65.5%/69.4% for clinical response”[2014]
      • high pre-treatment hemoglobin was also a predictor of good response [2014]
      • The sensitivity and specificity in predicting response to IFX based on this gene profiling was 95% and 85%, respectively.[2014]
      • all of these studies more severe disease was associated to adverse outcomes and less favorable response to anti-TNF [2014]
  • “(8.9%) developed a systemic adverse reaction to infliximab” [2015]
  • “Chronic sinusitis.. approximately 2%”[2014]
  • infusion reactions and delayed hypersensitivity 10% [2014] 27% [2014]
    • Mild and moderate IR occurred in 17% [2014]
  • Adverse drug reaction: 41.4% [2014] 35%[2014]
  • Serious adverse events: 67.9% [2014]
    • ” AEs associated with withdrawal occurred in 4% of all administered biologic therapies.”[2015]
  • 48.48 % of patients who received infliximab presented (ANA, ENA, anti-dsDNA) autoantibodies [2014]
  • Infections and elevation of transaminases occurred in 28.40% [2014]
    • severe infections 6%  [2014]
  • [2014]
    • Anaphylaxis:  6%
    • mild acute infusion reaction in 6%
    • hypotension in 6%
    • respiratory distress 6%
    • skin rash and eruptions 6%
    • hypertension 3%
    • tightness in the chest 3%

No statistics on, but..

  • ” an increase in weight” [2015]
  • “an association between focal mucinosis and thyroid dysfunction, as well as possible adverse effects of biological therapy with TNF-α antagonists.”[2014]
    • “Cytomegalovirus subacute thyroiditis in a patient treated by infliximab for psoriatic arthritis.” [2015]
  • ” probably exert a direct, toxic effect on the bone marrow”[2014]
  • Mycobacterium chelonae bacteremia [2014]
  • Hepatitis [2013]
  • Herpes zoster[2014]
  • Aseptic meningitis [2014] – 5 cases at least reported
  • a significant association with lupus [2014]
  • ” infliximab-associated psoriasiform lesions in an ulcerative colitis patient” [2015]
  • ” significantly increased incidence of serious infection ranging 1.2-2.78 times that of control (treatment with methotrexate) [than infliximab].” [2015]
  • “antitumor necrosis factor agents, such as infliximab, have variable drug clearance across individuals, mostly related to the disease burden at the time of an infusion.”[2015]
  • “Immediate hypersensitivity reactions (HR) to IFX are frequently reported.” [2015]
  • “Demyelinating polyneuropathy after long-term treatment with infliximab.” [2015]
  • “Infliximab-induced thrombocytopenia in a patient with ulcerative colitis.” [2015]
  • “Refractory highly disfiguring lupus pernio: a dramatic and prolonged response to infliximab.” [2015]
  • “Nephrotic syndrome after infliximab treatment in a patient with ulcerative colitis.” [2015]

Example of possible misdirection

  • “No adverse events related to dose escalation were observed.” [2015] i.e. there were adverse events, but those were for the drug and not for the dosage…