Randomised, blind, placebo controlled trials
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Jewell1 (n = 80) | AZA of no benefit in acute flare compared with placebo (standard steroid course given to all) | Some maintenance benefit in preventing relapse in established disease noted. |
Caprilli2 (n = 20) | No significant difference between sulphasalazine and AZA in active colitis | 3 month study. Improvement in symptoms and histology with both drugs. |
Rosenberg5 (30) | No clinical or mucosal improvement with AZA after 6 months compared with placebo in chronic UC | Dose 1.5 mg/kg. Steroid sparing effect noted. |
Kirk3 (n = 44) | Significant improvement in chronic UC in AZA group at 3 and 6 months | Steroid sparing effect noted. No difference in clinical activity scores between AZA and placebo |
Hawthorne6 (79) | Relapse at 1 year 36% (AZA) compared with 59% for placebo | Placebo controlled withdrawal study following remission in chronic UC. |
Ardizzone14 (n = 72) | Remission at 6 months was 53% for AZA and 21% for 5-aminosalicylic acid | All patients on 40 mg prednisolone at study entry. Steroid sparing effect confirmed. However, investigator blind only. Not double dummy. |
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Randomised open label studies
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Paoluzi10 (42) | 69% complete remission of steroid dependant/resistant UC at 6 months | Methotrexate used if intolerant to AZA. Methotrexate relapse rate found to be less than AZA. |
Sood4 (25) | Relapse rate of AZA comparable with sulphasalazine group in the maintenance of remission in severe acute newly diagnosed UC (standard steroid course given to all) | Trend towards earlier treatment failure in AZA group. |
Mate-Jimenez13 (72 (34 UC/39 CD)) | For steroid dependant UC remission rate was 79% for AZA (p<0.05), 58% for methotrexate (NS) compared with 25% for 5ASA. | Only comparison of AZA with methotrexate in UC. |
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Retrospective/case series
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Adler8 (81) | 63% remission response rate with 6MP in refractory UC | In 48% steroids were eliminated for a mean period of 19 months. |
George9 (105) | 65% achieved complete and 24% partial clinical remission with 6MP | Discontinuation of 6MP resulted in a higher relapse rate compared with those continuing 6MP. |
Fernandez-Banares19 (10) | 10% relapse rate with AZA as maintenance over mean of 16 months in this series | AZA used as maintenance therapy following intravenous ciclosporin in severe acute UC. |
Ardizzone12 (56) | 69% steroid resistant/dependant UC in remission and off steroids at 3 years with AZA | AZA response associated with steroid reduction/elimination, reduced colectomy, and reduced relapse rates. |
Khan7 (111 (53 UC/58 CD)) | Clinical improvement in 84% of IBD patients at 1 year with AZA, 68% of whom were off steroids | Relatively low dose of AZA 1.5 mg/kg. |
Fraser11 (626 (346 UC/242 CD/4 indeterminate)) | 58% remission rate with AZA for UC | Relapse rate similar for UC and CD patients. |