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Olsalazine Is Not Superior to Placebo in Maintaining Remission Of

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Olsalazine Is Not Superior to Placebo in Maintaining Remission Of 552 Gut 2001;49:552–556 Olsalazine is not superior to placebo in maintaining remission of inactive Crohn’s colitis Gut: first published as 10.1136/gut.49.4.552 on 1 October 2001. Downloaded from and ileocolitis: a double blind, parallel, randomised, multicentre study N Mahmud, M A Kamm, J L Dupas, D P Jewell, C A O’Morain, D G Weir, D Kelleher Abstract their participation in the trial than those Background and aims—The benefit of taking placebo. This diVerence was not 5-aminosalicylic acid therapy for mainte- related to relapse of disease, as measured nance of remission in Crohn’s disease is by CDAI and clinical measures, but rather controversial. The primary aim of this was due to the development of intolerable study was to evaluate the prophylactic adverse medical events of a non-serious properties of olsalazine in comparison nature related to the gastrointestinal with placebo for maintenance of remis- tract. The gastrointestinal related events sion in quiescent Crohn’s colitis and/or in the olsalazine treated group may be due ileocolitis. to the diVerence in gastrointestinal status Methods—In this randomised, double at baseline which favoured the placebo blind, parallel group study of olsalazine treatment group. versus placebo, 328 patients with quiescent (Gut 2001;49:552–556) Crohn’s colitis and/or ileocolitis were re- cruited. Treatment consisted of olsalazine Keywords: olsalazine; Crohn’s disease; colitis; ileocolitis 2.0 g daily or placebo for 52 weeks. The pri- mary end point of eYcacy was relapse, as Department of Clinical defined by the Crohn’s disease activity Sulphasalazine has been in use for almost four Medicine, Trinity index (CDAI) and by clinical relapse. decades as a therapeutic and prophylactic College, St James’s Laboratory and clinical disease activity agent for the treatment of inflammatory bowel Hospital, Dublin, indicators were also measured. Safety Ireland disease. The sulphapyridine moiety is now analysis consisted of documentation of known to cause the majority of the idiosyn- N Mahmud http://gut.bmj.com/ DGWeir adverse events and laboratory values. cratic adverse reactions of sulphasalazine D Kelleher Results—No diVerences in the frequency whereas 5-aminosalicylic acid (5-ASA) is the of termination due to relapse or time to therapeutically active moiety.1–4 In recent years Department of termination due to relapse were noted several sulphapyridine free 5-ASA products Medicine and between the two treatment groups (olsala- Gastroenterology, St have been developed, such as olsalazine and zine 48.5% v placebo 45%) for either colitis 4–6 Mark’s Hospital, mesalazine. Northwick Park, UK or ileocolitis. The failure rate, defined as Olsalazine consists of two 5-ASA molecules M A Kamm not completing the study, was significantly linked by an azo bond. Like sulphasalazine, the on September 25, 2021 by guest. Protected copyright. higher in olsalazine treated patients com- azo bond of olsalazine is split in the colon, Department of pared with placebo treated patients for the releasing both 5-ASA molecules to exert local Medicine and overall population (colitis and/or ileocoli- therapeutic activity.67 Other formulations of Gastroenterology, tis: olsalazine 65.4% v 53.9%; p=0.038). Hospital Nord, oral 5-ASA use pH dependent coatings to Amiens, France Similar failure rates were seen for patients release 5-ASA to the target tissue.78 Sul- J L Dupas with colitis. A significantly higher per- phasalazine has been shown to be superior to centage of olsalazine treated patients placebo in preventing recurrence in quiescent Gastroenterology Unit, experienced adverse gastrointestinal Crohn’s disease.9 However, the role of mesala- RadcliVe Infirmary, events. Drug attributed adverse events zine in the prevention of relapse in quiescent Oxford, UK were reported more frequently in the D P Jewell Crohn’s disease is controversial according to olsalazine treated group with gastro- published studies.10–12 Department of Clinical intestinal symptoms being causally re- Olsalazine is a well tolerated maintenance Medicine, Trinity lated to olsalazine treatment (olsalazine agent for the treatment of ulcerative colitis.13–15 College, Meath and 40.7% v placebo 26.9%; p=0.010). Back The role of olsalazine in induction and mainte- Adelaide Hospital, pain was reported significantly more often nance of remission in Crohn’s colitis and/or Tallaght, Dublin, by the placebo treated group. However, Ireland ileocolitis has not yet been evaluated. C A O’Morain serious medical events did not diVer This trial was designed to evaluate the between the two groups. Adverse events prophylactic properties of olsalazine in compari- Correspondence to: led to more early withdrawals in the son with placebo for maintenance of remission Dr N Mahmud, Department olsalazine treated group than in the of Clinical Medicine, Trinity in quiescent Crohn’s disease. This study was College Dublin, Trinity placebo treated group; thus average time confined to patients with Crohn’s colitis and/or Centre for Health Sciences, in the study for patients in the olsalazine ileocolitis. The trial was a randomised, double St James’s Hospital, Dublin treatment group was significantly shorter 8, Ireland. [email protected] than that of patients in the placebo group. Abbreviations used in this paper: ASA, Accepted for publication Conclusions—Patients treated with ol- 5-aminosalicylic acid; CDAI, Crohn’s disease activity 29 January 2001 salazine were more likely to terminate index; CRF, case report form. www.gutjnl.com Olsalazine in inactive Crohn’s colitis and ileocolitis 553 blind, parallel group study of 328 patients. Olsalazine was administered as 250 mg cap- Patients were treated with 2.0 g of olsalazine or sules. The final maintenance dose of 2.0 g daily 2.0 g of placebo daily for 52 weeks. was to be established during a period of one Gut: first published as 10.1136/gut.49.4.552 on 1 October 2001. Downloaded from month and was not changed thereafter. The Methods full drug dose was achieved by successive dose A total of 328 patients of either sex, aged 18 escalation over an eight day period. Identical years or over with established Crohn’s colitis placebos were provided by Kabi Pharmacia. and/or ileocolitis in complete remission were enrolled during February 1992 to January 1996 (demographic details are shown in table CONCOMITANT MEDICATION No other active medication for Crohn’s disease 1). Disease activity was monitored by the was permitted. However, other medications, Crohn’s disease activity index (CDAI)16 for one including antidiarrhoeals agents such as co- month prior to randomisation. Patients were deine and loperamide, were recorded on the treated with olsalazine or placebo for 52 weeks. CRFs. CDAI measurements including haematocrit and routine blood biochemistry were per- formed at the pre-study visit (−4 week), at the EFFICACY ASSESSMENT AND PRIMARY END POINT start of treatment (0 week), and at weeks 4, 13, The primary end point of eYcacy was relapse, 26, 39, and 52. defined by a CDAI score >150 or an increase in the CDAI score by 60 or more from the base- INCLUSION CRITERIA line score at visit 2 (week 0). Clinical relapse Patients aged 18 years or over with a diagnosis was defined as the need for additional therapy of Crohn’s colitis and/or ileocolitis established or for surgery: in exceptional situations where radiologically and/or endoscopically and/or CDAI criteria were not fulfilled. histologically within the five years before entry into study were included. All patients had a barium follow through/small bowel enema to SAFETY ASSESSMENTS Safety assessments were carried out in all assess the extent of small bowel disease. recruited patients at weeks 0, 13, 26, and 52 Patients in remission for at least one month and at the time of termination of the study. prior to randomisation were included. Remis- Parameters were routine haematology, bio- sion was defined clinically (as assessed by the chemistry including serum urea/electrolyte, investigator) and objectively by a CDAI score creatinine, bilirubin, aspartate transferase, and of less than 150. Written informed consent was alkaline phosphatase, and urinalysis for protein obtained from all patients who participated in and blood (sediment was measured if urine was this study. positive for blood or protein). EXCLUSION CRITERIA http://gut.bmj.com/ Patients were excluded from the study if they STATISTICAL ANALYSIS received steroid, azathioprine, or other immu- All analyses were produced using UNIX SAS nosuppressive (other than 5-ASA) therapy one version 6.09. The sample size was initially cal- month prior to week −4 or during the study culated for per protocol analysis of relapse rate period. Other exclusion criteria included con- assuming a placebo relapse rate of 35% (clini- comitant therapy with antibiotics for more than cally important diVerence in relapse rate was one month. Patients who were pregnant, defined as 15%). Analyses were performed on September 25, 2021 by guest. Protected copyright. intending to be pregnancy, or breast feeding, comparing the olsalazine treatment group with and those with clinically significant hepatic or the placebo group. Unless otherwise specified, renal insuYciency, strictures causing mechani- these analyses were conducted with a signifi- cal obstruction, fistulae, oral or symptomatic cance level of 0.05 and the sample size needed anal Crohn’s disease, stoma or significant small 138 evaluable patients per treatment group. bowel disease apart from terminal ileal disease, For demographic/baseline data, the analysis and patients with known hypersensitivity to included only treatment in the model and was salicylates were excluded. a comparison of the two treatment groups. Patients rejected at week 0 could be entered Categorical data were analysed using the ÷2 at a later stage if they met the inclusion criteria test. Continuous variables were analysed using and none of the exclusion criteria. All patients one way ANOVA.
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