P-151 Utilizing Anti-TNF Levels and Drug Antibodies to De-escalate Therapy in Patients with IBD. (February 2017)

• Record Type: Journal Article
• Authors: O'Brien, Corey; Aguilar, Rodrigo; Chang, Jennifer; LeStrange, Aimee; O'Hara, Melissa; Mattar, Mark; Charabaty, Aline
• Is Part Of: Inflammatory bowel diseases. Volume 23(2017)Supplement 1
• Publication Date: 2017-02
• Subjects: Inflammatory bowel diseases -- Periodicals; Colitis, Ulcerative -- Periodicals; Crohn Disease -- Periodicals; Inflammatory Bowel Diseases -- Periodicals; 616.344
• DOI: 10.1097/01.MIB.0000512669.24595.8a
• Languages: English
• ISSNs: 1078-0998

Abstract

Abstract : Background: Anti-tumor necrosis factor (anti-TNF) agents are effective at inducing and maintaining clinical remission and endoscopic healing in patients with IBD. Anti-TNF use is also associated with significant cost and potential side effects. Recent advances in therapeutic drug monitoring have guided dose intensification and adjustment decisions in patients who fail to respond to standard doses of anti-TNF. Data from the TAXIT trial suggest that patients with high infliximab (IFX) trough level (TL) who are in clinical remission can have their dose of IFX de-escalated successfully. Our aim was to assess whether this strategy is effective in our IBD patients. Methods: This was a single-center study looking at IBD patients seen at the MedStar-Georgetown University Hospital IBD Clinic. Inclusion criteria: IBD patients over 18 years old who for more than 6 months have been: on a stable dose of IFX, off steroids, and in clinical and endoscopic remission (assessed by colonoscopy or abdominal imaging). If IFX TL was >7 μg/mL, IFX dose was decreased by either 2.5 mg/kg (if the baseline dose was more than 5 mg/kg) or 1 mg/kg (if the baseline dose was 5 mg/kg). After 2 infusions of IFX at the new dose, we rechecked trough level and antibodies to IFX (i.e., ATI). Patients were followed clinically and with CRP and fecal calprotectin at 12 weeks after the decreased dose and every 6 months thereafter. Colonoscopy was performed if a patient developed flare symptoms or had an increase in CRP or fecal calprotectin and at 12 months from initiation of decreased dosage. Results: Sixteen patients met the inclusion criteria, of which 9 had IFX TL >7 μg/mL. Of those, 7 were female and 6 had Crohn's disease. The average duration of IBD was 15 years and average duration of IFX therapy was 6 years. Half of the patients had repeat IFX TL and ATI drawn after dose change. There was no significant change in IFX TL (16.58 versus 16.43 μg/mL, P = 0.87) and no increase in ATI. Patients remained in clinical and endoscopic remission at 1 year follow-up. In addition, CRP did not significantly increase after decreasing the IFX dosage (3.57 versus 3.61 mg/L, P = 0.79). Conclusions: Our data suggests that the dose of IFX can be successfully decreased in patients who are in sustained clinical and endoscopic remission with supratherapeutic IFX TL. Larger studies with long-term follow up, as well as examining the effect of concomitant use of immunosuppressants, are needed before making general recommendations on dose de-escalation.