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Dig Dis Sci. 2019 Feb 28. doi: 10.1007/s10620-019-05490-0. [Epub ahead of print]

Efficacy of Infliximab in Crohn's Disease Patients with Prior Primary-Nonresponse to Tumor Necrosis Factor Antagonists.

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Division of Gastroenterology, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA.
Division of Gastroenterology, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA.



Tumor necrosis factor antagonists (TNFs) are effective for moderate-severe Crohn's disease (CD). Approximately one-third of patients have primary-nonresponse to TNFs, which is reported to predict worse response to subsequent TNF therapy. However, this is based on treatment with subcutaneously (SC) administered, fixed-dose TNFs after failure of intravenously (IV) administered, weight-based TNFs. No study has specifically assessed the clinical and endoscopic effectiveness of IV TNFs following primary-nonresponse to SC TNFs. We hypothesize that IV, weight-based TNF dosing offers advantages over SC, fixed-dose TNFs and may be effective despite primary-nonresponse to previous SC fixed-dose TNFs.


This retrospective cohort study identified patients with moderate-severe CD with primary-nonresponse to one or more SC TNFs who subsequently received the IV TNF, infliximab for ≥ 12 weeks. We described baseline characteristics, and clinical, endoscopic and biochemical response to therapy.


Key characteristics of 17 patients are described in Table 1. After ≥ 12 weeks of infliximab, 11 of 15 (73.3%) patients with clinical data reported clinical response and remission. Of 11 patients with endoscopic data, restaging colonoscopy revealed mucosal improvement in seven (63.6%) patients. Of these, five (45.5%) had endoscopic remission and three (27.3%) had mucosal healing. Table 1 Baseline characteristics of CD patients with primary-nonresponse to subcutaneous (SC) tumor necrosis antagonists (TNF), subsequently treated with intravenous (IV) TNF therapy Characteristics N 17 Mean age, years (range) 37.5 (18-67) Mean BMI, kg/m2 (range) 26.6 (17.8-40.6) Mean albumin prior to infliximab, g/dL (range) RR: 3.5-5.2 g/dL 3.57 (2.5-4.2) Female sex [n (%)] 7 (41.2) Tobacco use [n (%)]  Never 15 (88.2)  Former 1 (5.88)  Current 1 (5.88) Age at diagnosis [n (%)]  Less than 17 2 (11.8)  17-40 11 (64.7)  Over 40 4 (23.5) Mean disease duration, yrs (range) 7.76 (1-24) Disease extent [n (%)]  Ileal 2 (11.8)  Colonic 5 (29.4)  Ileocolonic 10 (64.7) Disease behavior [n (%)]  Nonstenosing, nonpenetrating 10 (58.8)  Stenosing 3 (17.6)  Penetrating 2 (11.8)  Stenosing and penetrating 2 (11.8) History of gastrointestinal surgery [n (%)] 4 (23.5)  Ileocecal resection (n) 2  Hemicolectomy (n) 2 Prior therapy [n (%)]  IV corticosteroids 3 (17.6)  Oral corticosteroids 14 (82.4)  5-ASA 12 (70.6)  Thiopurine 14 (82.4)  Methotrexate 10 (58.8) Prior biologic therapy  Adalimumab only 12 (70.6)  Certolizumab pegol only 2 (11.8)  Adalimumab and certolizumab pegol 2 (11.8)  Adalimumab, certolizumab pegol and golimumab 1 (5.88) Dose escalation of prior SC TNF [n (%)]  Adalimumab 9 (52.9)  Certolizumab pegol 0 (0.0)  Golimumab 0 (0.0) During infliximab, concomitant therapy [n (%)]  Immunomodulator 13 (76.5)  Corticosteroid 5 (29.4) CONCLUSIONS: Patients with moderate-severe CD with prior primary-nonresponse to SC, fixed-dose TNFs, subsequently treated with IV, weight-based TNF have high rates of clinical and endoscopic response and remission. Therefore, despite primary-nonresponse to SC TNFs, patients may benefit from IV TNF therapy and may not require a change to a different class of biologic therapy.


Crohn’s disease; Infliximab; Primary-nonresponse; Tumor necrosis factor antagonist


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