Treatment patterns and intensification within 5 year of follow-up of the first-line anti-TNFα used for the treatment of IBD: Results from the VERNE study

Bastida, Guillermo; Marín-Jiménez, Ignacio; Forés, Ana; Garcia-Planella, E.; Argüelles‐Arias, Federico; Tagarro, Ignacio; Fernández-Nistal, Alonso; Montoto, Carmen; Aparicio, Juan Carlos; Aguas, M.; Santos-Fernández, Javier; Boscá-Watts, Marta Maia; Ferreiro-Iglesias, Rocío; Merino, Olga; Aldeguer, Xavier; Cortés, Xavier; Sicilia, B; Mesonero, Francisco; Acosta, Manuel Barreiro‐de

doi:10.1016/j.dld.2021.06.005

Cited by 10 publications

(6 citation statements)

References 47 publications

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“… 15–18 Generally loss of response and need for dose adjustment occur more often in UC patients given adalimumab compared with infliximab. 16 Furthermore, the clinical remission rate for adalimumab at Week 52 was 22%, 19 corroborated in the first head-to-head study of vedolizumab and adalimumab, 20 and without improvement with dose intensification. 21 In VARSITY, adalimumab-treated patients [82/147, 55.8%] discontinued because of lack of efficacy at a higher rate than vedolizumab-treated patients [41/96, 42.7%].…”

Section: Discussionmentioning

confidence: 68%

“…In anti TNF-α treated patients, UC patients required dose escalation more often and more quickly than patients with Crohn’s disease [CD]. 15 , 16 Overall, 30-40% of patients discontinue biologic therapy over time due to side effects or failure to achieve clinical benefit. 15–18 Generally loss of response and need for dose adjustment occur more often in UC patients given adalimumab compared with infliximab.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and Safety of Maintenance Ustekinumab for Ulcerative Colitis Through 3 Years: UNIFI Long-term Extension

Abreu

Rowbotham

Danese

et al. 2022

Journal of Crohn's and Colitis

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Background and Aims The UNIFI long-term extension (LTE) study reports the efficacy and safety of subcutaneous 90 mg ustekinumab through three years of maintenance therapy. Methods Patients randomized to ustekinumab q12w or q8w at maintenance baseline (N=348) and randomized ustekinumab-treated patients in the LTE (N=284) were evaluated. Symptomatic remission (Mayo stool frequency=0/1, rectal bleeding=0) was assessed. Safety included all LTE patients (N=188 placebo and N=457 ustekinumab). Results Among patients randomized to the ustekinumab q12w and q8w groups at maintenance baseline, 54.1% and 56.3% achieved symptomatic remission at week 152. Overall, 20% of patients discontinued ustekinumab, 10% of biologicnaïve and 30% of biologic-exposed patients. Among patients in symptomatic remission at year 3, 94.6% and 98.0% of patients were also corticosteroid free. Corticosteroid-free symptomatic remission rates in the ustekinumab q12w and q8w groups were 51.2% and 55.1% at week 152. Remission rates were higher for biologic-naïve patients than those with a history of biologic failure. Biochemical evidence of response was demonstrated by stable, decreased CRP and fecal calprotectin measurements over 3 years. From weeks 96-156, no deaths, major adverse cardiovascular events, or tuberculosis occurred. Nasopharyngitis, ulcerative colitis and upper respiratory tract infection were most frequently reported. One ustekinumab-treated patient with a history of basal cell carcinoma (BCC) reported 2 BCC. One patient in the q8w ustekinumab group who was receiving concomitant 6-mercaptopurine experienced SAEs of neutropenic sepsis and oral herpes. Conclusion Efficacy of ustekinumab in patients with ulcerative colitis was confirmed through 3 years. No new safety signals were observed.

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Section: Discussionmentioning

confidence: 68%

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Maintenance Ustekinumab for Ulcerative Colitis Through 3 Years: UNIFI Long-term Extension

Abreu

Rowbotham

Danese

et al. 2022

Journal of Crohn's and Colitis

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“… 28 High rates of treatment discontinuation due to lack of appropriate disease control, including loss of response, indicate the need for appropriate intensification regimens. 29 , 30 The approval of ADA administered as 80 mg eow for the treatment of patients with IBD as an alternative to the standard intensification regimen of 40 mg ew offers an alternative intensification regimen that some patients may find more convenient. In this retrospective analysis, treatment intensification to ADA 80 mg eow among patients with IBD receiving treatment with ADA 40 mg ew was associated with high rates of both clinical and biological remission.…”

Section: Discussionmentioning

confidence: 99%

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

Moya

Lama

Antorán

et al. 2023

Crohn's &Amp; Colitis 360

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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.

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“…The incidence rate of primary nonresponse and loss of response was approximately 10% to 30%. 35,36 Although succeeding in primary response, secondary nonresponse and AEs with IFX were not uncommon. [37][38][39] Patients would increase the dose of IFX, shorten the interval, or switch to other therapies, which increases significantly the costs and pressure on the CHS.…”

Section: Discussionmentioning

confidence: 99%

Comparison between washed microbiota transplantation and infliximab: Medical cost during long-term management in patients with inflammatory bowel disease

Zhang,

Huang,

et al. 2023

Journal of the Chinese Medical Association

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Background: Both infliximab (IFX) and fecal microbiota transplantation (FMT) have shown the efficacy for inflammatory bowel disease (IBD). However, there has no head-to-head study on the cost-value of the such treatments on IBD. This study aimed to compare the medical costs using IFX and the new method of FMT (washed microbiota transplantation, WMT) in the long-term management for IBD under the current health economic condition in China. Methods: Patients with IBD who underwent initial WMT via upper gastrointestinal endoscopy, mid-gut tube, or colonic transendoscopic enteral tubing at a university hospital between April 2013 and August 2021 and achieved the long-term sustainment with WMT or WMT combined with mesalazine until August 2022 were recruited in the real-world. The costs and hospitalizations were analyzed among two therapies mentioned above and IFX standard therapy. The charge of WMT was stable in the long term at our center, and the charge of IFX came from virtual statistics publicized by China Healthcare Security. Results: 60 eligible patients with IBD were included in the study. The long-term costs of patients using WMT monotherapy annually or per hospitalization were lower than those on WMT combined with mesalazine respectively (p < 0.001, respectively). The cumulative costs of IFX at the time of 0.52 and 0.85 years exceeded that of the above WMT respectively (p < 0.001, respectively). Besides, patients on WMT monotherapy paid 51.1k CNY annually in the non-sustain phase but cut down the costs by 7.2k CNY and duration of hospitalization by 5.1 days per hospitalization when reaching the goal of sustainment. Conclusion: This study demonstrated that WMT could dramatically reduce the cost and duration of hospitalizations in the long-term sustainment in the current Chinese IBD cohort. Compared with IFX, WMT could be a good way for the patients with IBD achieving long-term sustainment and saving medical costs.

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Treatment patterns and intensification within 5 year of follow-up of the first-line anti-TNFα used for the treatment of IBD: Results from the VERNE study

Cited by 10 publications

References 47 publications

Efficacy and Safety of Maintenance Ustekinumab for Ulcerative Colitis Through 3 Years: UNIFI Long-term Extension

Efficacy and Safety of Maintenance Ustekinumab for Ulcerative Colitis Through 3 Years: UNIFI Long-term Extension

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

Comparison between washed microbiota transplantation and infliximab: Medical cost during long-term management in patients with inflammatory bowel disease

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