Journal
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
Volume 41, Issue 1, Pages 77-86Publisher
WILEY
DOI: 10.1111/apt.13001
Keywords
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Funding
- Merck
- Abbott Labs
- Centocor Inc.
- Given Imaging
- UCB Pharma
- ActoGenix
- Boehringer-Ingelheim
- Cosmo Technologies
- EnGene Inc
- Ferring Pharmaceuticals
- Millennium Pharmaceuticals
- Elan/Biogen
- Janssen-Ortho
- Teva Pharmaceuticals
- Astra Zeneca
- Shire
- Tillotts Pharma AG
- Novonordisk
- GSK
- Pfizer
- Sigmoid Pharma
- Novartis Pharmaceuticals
- Bristol-Myers Squibb
- Genentech
- Wyeth Pharmaceuticals Inc.
- Celgene
- Serono
- Unity Pharmaceuticals
- Albireo Pharma
- Given Imaging Inc.
- Salix Pharmaceuticals
- Prometheus Therapeutics and Diagnostics
- Athersys
- Axcan
- Gilead
- Wyeth
- Zealand Pharma
- Zyngenia
- GiCare Pharma Inc.
- Abbott
- ActoGeniX NV
- AGI Therapeutics Inc
- Alba Therapeutics Corp
- Albireo
- Alfa Wasserman
- Amgen
- AM-Pharma BV
- Anaphore
- Astellas
- Athersys Inc
- Atlantic Healthcare Ltd
- Aptalis
- BioBalance Corp
- Celek Pharmaceuticals
- Cellerix SL
- Cerimon Pharmaceuticals
- ChemoCentryx
- CoMentis
- Coronado Biosciences
- Cytokine Pharmasciences
- Eagle Pharmaceuticals
- Eli Lilly
- Enteromedics
- Exagen Diagnostics Inc
- Flexio Therapeutics Inc
- Funxional Therapeutics Ltd
- Genzyme Corp
- Gilead Sciences
- Human Genome Sciences
- Ironwood Pharmaceuticals
- KaloBios Pharmaceuticals
- Lexicon Pharmaceuticals
- Lycera Corp
- Meda Pharmaceuticals
- Merck Research Laboratories
- Merck Serono
- Nisshin Kyorin Pharmaceuticals
- Novo Nordisk
- NPS Pharmaceuticals
- Optimer Pharmaceuticals
- Orexigen Therapeutics Inc
- PDL Biopharma
- Procter and Gamble
- Prometheus Laboratories
- ProtAb Ltd
- Purgenesis Technologies Inc
- Relypsa Inc
- Roche
- Salient Pharmaceuticals
- Santarus
- Schering Plough
- Shire Pharmaceuticals
- Sigmoid Pharma Ltd
- Sirtris Pharmaceuticals
- SLA Pharma UK Ltd
- Targacept
- Therakos
- TxCell SA
- Viamet Pharmaceuticals
- Vascular Biogenics Ltd
- Warner Chilcott UK Ltd
- Janssen
- Milennium Pharmaceuticals
- Novartis
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BackgroundThe Crohn's Disease Activity Index (CDAI) is a measure of disease activity based on symptoms, signs and a laboratory test. The US Food and Drug Administration has indicated that patient reported outcomes (PROs) should be the primary outcome in randomised controlled trials for Crohn's disease (CD). AimAs no validated PRO exists for CD, to investigate whether CDAI diary card items could be modified for this purpose. MethodsData from a trial of rifaximin-extended intestinal release were used to identify cut-points for stool frequency, pain and general well-being using receiver operating characteristic curves with CDAI <150 as criterion. The operating properties of 2- and 3-item PRO were evaluated using data from a trial of methotrexate in CD. Regression analysis determined PRO2 and PRO3 scores that correspond to CDAI-defined thresholds of 150, 220 and 450 and changes of 50, 70 and 100 points. ResultsOptimum cut-points for CDAI remission were mean daily stool frequency 1.5, abdominal pain 1, and general well-being score of 1 (areas under the ROC curve 0.79, 0.91 and 0.89, respectively). The effect estimates were similar using 2- and 3-item PROs or CDAI. PRO2 and PRO3 values corresponding to CDAI scores of 150, 220 and 450 points were 8, 14, 34 and 13, 22, 53. The corresponding values for CDAI changes of 50, 70 and 100, were 2, 5, 8 and 5, 9, 14. Responsiveness to change was similar for both PROs. ConclusionPatient reported outcomes derived from CDAI diary items may be appropriate for use in clinical trials for CD.
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