Crohn's disease: IL-10 increases remission rates in mild to moderately active cases but adverse effects are common

Clinical bottom line (level 1b)

  1. Patients with mild to moderately active Crohn's disease who received IL-10 compared with placebo were more likely to go into remission (NN T = 8 at 29 days) .
  2. However adverse effects were more common - particularly headache (NN T = 2 at 29 days) , fatigue (NN H = 4 at 29 days) and fever (NN H = 5 at 29 days) .
Fedorak et al: Gastroenterology 2000; 119 : 1473-1482
Expires October 2003

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: 27 acute hospitals, Africa, Australia, Canada, Europe, USA

95 patients (aged 21 to 75; mean 38, 54% female) with mild to moderately active Crohn's disease of the ileum and/or colon and a Crohn's Disease Activity Index score (CDAI) between 200 and 350.

Excluded if
  • pregnant or breast-feeding
  • history of cancer
  • clinically significant abnormal chest X-ray or ECG
  • hepatitis B or C, or HIV positive
  • alcohol or drug abuse within previous 5 years
  • colostomy or ileostomy
  • intestinal resection resulting in small bowel syndrome
  • isolated small bowel involvement not evaluable with endoscopy
  • stricture with bowel obstruction
  • stool culture positive for C. difficile or other pathogens
  • previous treatment with IL-10
  • changing dose of mesalamine or sulfasalazine within previous 2 weeks, and less than 4.8 g/day
  • steroids within previous 30 days
  • methotrexate, cyclosporine, azathioprine, mercaptopurine within previous 90 days
  • received parenteral or defined oral diets, topical mesalamine, antibiotics, NSAIDs, aspirin or codeine within previous 14 days
  • aged < 18

    Control Group: (n = 23, 23 analysed): placebo
    Experimental Group: (n = , analysed): IL-10 1 to 20 microgram sc daily

    0% followed for 29 days
    Outcome notes:
    • remission : CDAI < 150

    The evidence

    Outcome Time to outcome CER EER RRR
    (95% CI)    		 ARR
    (95% CI)    		 NN T
    (95% CI)
    remission 29 days 0
    (0.0%)    		 9
    (12.5%)    		 %
    (% to %)    		 12.5%
    (4.86% to 20.1%)    		 8
    (5 to 21)
    headache 29 days 9
    (12.5%)    		 41
    (56.9%)    		 -360%
    (-770% to -140%)    		 -44.4%
    (-58.2% to -30.7%)    		 -2
    (-2 to -3)
    fatigue 29 days 4
    (5.56%)    		 21
    (29.2%)    		 -430%
    (-1400% to -90%)    		 -23.6%
    (-35.4% to -11.9%)    		 -4
    (-8 to -3)
    fever 29 days 4
    (5.56%)    		 18
    (25.0%)    		 -350%
    (-1200% to -60%)    		 -19.4%
    (-30.8% to -8.13%)    		 -5
    (-12 to -3)

    Comments

    1. 5 microgram/kg per day was reported to be the most efficicious dose, since at higher doses reversible anaemia and thrombocytopenia was noted. However patient numbers in each dosing group were small (~18) making these results less certain.
    2. Since patients did not receive other medication for treating the Crohn's exacerbation, the role of IL-10 in clinical practice is unclear.

    Citation

    1. Fedorak RN, Gangl A, Elson CO, et al: recombitant human interleukin 10 in the treatment of patients with mild to moderately active Crohn's disease. Gastroenterology 2000; 119 : 1473-1482
    Search Terms: from ACP Journal Club other articles noted
    Contributor: Chris Ball, October 2001
    Reviewer:

    Clinical Question.
    Patient
    Intervention or Exposure
    Outcome