Change in erythrocyte mean corpuscular volume during combination therapy with azathioprine and infliximab is associated with mucosal healing: a post hoc analysis from SONIC

The adequacy of exposure of purine analogs as measured by 6-thioguanine nucleotides concentrations in the setting of combination therapy remains poorly understood. The aim of this study was to investigate the relationship between the mean corpuscular volume (MCV) value (as a surrogate marker of 6-th...

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Published in:Inflammatory bowel diseases 2015-03, Vol.21 (3), p.606-614
Main Authors: Bouguen, Guillaume, Sninsky, Charles, Tang, Kezhen L, Colombel, Jean-Frederic, DʼHaens, Geert, Kornbluth, Asher, Mantzaris, Gerassimos J, Rachmilewitz, Daniel, Reinisch, Walter, Rutgeerts, Paul, Molenda, Mark, Jannekevan der Woude, C, Sandborn, William J
Format: Article
Language:English
Subjects:
Adult
Azathioprine - therapeutic use
Biomarkers - analysis
Crohn Disease - drug therapy
Crohn Disease - pathology
Double-Blind Method
Drug Therapy, Combination
Erythrocyte Indices - drug effects
Erythrocytes - drug effects
Erythrocytes - pathology
Female
Gastrointestinal Agents - therapeutic use
Humans
Immunosuppressive Agents - therapeutic use
Infliximab - therapeutic use
Life Sciences
Male
Mucous Membrane - drug effects
Mucous Membrane - pathology
Prognosis
Wound Healing - drug effects
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Summary:The adequacy of exposure of purine analogs as measured by 6-thioguanine nucleotides concentrations in the setting of combination therapy remains poorly understood. The aim of this study was to investigate the relationship between the mean corpuscular volume (MCV) value (as a surrogate marker of 6-thioguanine nucleotides concentration) and Crohn's disease outcomes in the setting of combination therapy with infliximab. The SONIC trial was a randomized controlled trial comparing infliximab to azathioprine and to infliximab plus azathioprine in 508 Crohn's disease patients. An increase of at least 7 femtoliter (fL) of the MCV (ΔMCV) was used for statistical analysis. At week 26, the mean increase of MCV was similar among patients treated with azathioprine alone (mean of 7.9 fL) or in combination with infliximab (mean of 8.5 fL). In the azathioprine group, 63.6% of patients with ΔMCV >7 were in steroid-free clinical remission at week 26 as compared with 33.3% of patients without ΔMCV >7 (P = 0.0046). In the combination therapy group, ΔMCV above 7 was associated with mucosal healing (75.0% for ΔMCV >7 versus 47.1% for ΔMCV
ISSN:1078-0998
1536-4844
DOI:10.1097/MIB.0000000000000302