Treatment With Adalimumab 80 mg Every Other Week in Inflammatory Bowel Disease: Results of Treatment Intensification in Clinical Practice

Abstract

Background Loss of response to anti-TNF drugs in patients with inflammatory bowel disease (IBD) is frequent and, in case of low drug levels, treatment intensification is recommended. In addition, in cases in which clinical response without attainment of remission (clinical, endoscopic or radiological), intensification could be justified since higher drug levels are associated with better outcomes. For adalimumab (ADA), the standard intensification regimen is 40mg every week (ew). Availability of ADA 80mg pre-filled pens has enabled every other week (eow) intensification. We assessed the clinical efficacy of intensification with ADA 80mg eow. Methods This retrospective study was conducted at a tertiary hospital in Spain. Patients with IBD receiving maintenance ADA 80mg eow with clinical, biomarker and drug level assessments were included. Demographics and clinical, biological and endoscopic evaluation of the disease before and after ADA intensification, and pharmacokinetic assessments, were collected. Results 87 patients (72 Crohn’s disease, 15 ulcerative colitis; average age 50 years) were included. Reasons for ADA intensification were: low ADA levels - <5 µg/mL - (17%), low ADA levels - <5 µg/mL- without clinical response (63%), clinical response without clinical remission (15%) and active disease on objective evaluation (including colonoscopy, MRI, capsule endoscopy and/or intestinal ultrasound; 5%). Following treatment intensification to ADA 80mg eow, 75 patients (86%) were in clinical remission and 69 (79.3%) were in biologic remission (clinical remission and normalisation of biomarkers). After a median follow-up of 19 months (IQR 13–25), 63 patients (72%) remained on treatment and in clinical remission. There were no serious infections, hospitalisations or deaths. Drug costs did not increase with the 80mg eow regimen vs a standard intensification regimen. Conclusions ADA intensification to 80mg eow was safe, effective and did not increase drug costs vs standard intensification to 40mg ew in our experience. •What is already known? Inadequate or loss of response to adalimumab in patients with inflammatory bowel disease can be managed by intensification of treatment to 40 mg every week. •What is new here? Treatment intensification to an alternative regimen of adalimumab 80 mg every other week was safe and effective in a real-world setting with high rates of clinical and biologic remission and no serious infections, hospitalisations or deaths. •How can this study help patient care? These results provide confidence that this alternative intensification regimen is safe and effective for patients with IBD experiencing inadequate or loss of response to adalimumab.