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Tu1365 Low Dose Naltrexone in the Treatment of Crohn's Disease: A Case Series
Gastroenterology
April 2015
http://www.gastrojournal.org/article/S0016-5085(15)32952-8/abstract
INTRODUCTION:: Crohn’s disease, a form of inflammatory bowel disease (IBD), is a chronic, relapsing condition that may evade remission despite new therapies. Many patients after years of disease may become resistant to previously effective treatments and thus different modalities are necessary for this moving target. Low dose naltrexone (LDN) has been implicated in the treatment of IBD by targeting partial opioid receptor blockade and thus leads to overproduction of endogenous opioids that have immunomodulatory effects. We report a case series of IBD patients treated with LDN as an adjunct to conventional therapies.
METHODS: All IBD patients treated with LDN (n=130) were identified retrospectively and reviewed for inclusion. Patients with at least 1 follow-up clinic visit and short inflammatory bowel disease questionnaire (SIBDQ) score at baseline were included. Clinical response was evaluated based on cessation of abdominal pain and/or diarrhea, increase in SIBDQ score, or decrease in Harvey Bradshaw Index (HBI). Response was further stratified as complete (cessation of abdominal pain and diarrhea) or partial (decreased symptoms or improved SIBDQ/HBI scores) based on degree of response. Radiographic changes and inflammatory markers were also analyzed when available.
RESULTS: 56 patients (82% female, mean age 45, range 20-81) were identified from January 2010 to October 2014 as IBD patients treated with LDN (4.5 mg or 9 mg). Majority of patients (80%) were identified as having refractory disease (mean number of previously used medications, 3.1). Concomitant treatments included anti-TNF agents (32%), systemic corticosteroids (25%), and immunomodulators (31%). Mean duration of LDN therapy was 14.4 months and mean time to response on LDN was 3.7 months. Clinical response was seen in 30 patients (54%), while 17 patients (30%) were non-responders. Complete and partial response was found in 19 (34%) and 11 patients (20%) respectively. 9 patients improved clinically but had concurrent medication changes at LDN initiation that could explain their improvement; therefore, their clinical response was excluded. 4 patients had interval radiographic changes, with improvement in bowel wall thickening or active disease on MR enterography. 4 patients had decreased inflammatory markers (CRP, ESR, or fecal calprotectin) while on LDN. 71% of patients on systemic steroids (n=10) were able to taper while on LDN. Adverse events were found in 16% of patients (insomnia, headache, nausea) with 2 patients discontinuing due to adverse events.
CONCLUSIONS: IBD patients show clinical response to LDN (54%) and should be considered as an adjunct to conventional therapy in patients with resistant disease or as a bridge while another treatment plan is formulated. Further studies are required to evaluate the degree of mucosal healing while on LDN.