Buisson Anthony, Serrero Mélanie, Orsat Laurie, Nancey Stéphane, Rivière Pauline, Altwegg Romain, Peyrin-Biroulet Laurent, Nachury Maria, Hébuterne Xavier, Gilletta Cyrielle, Flamant Mathurin, Viennot Stéphanie, Bouguen Guillaume, Amiot Aurélien, Mathieu Stéphane, Vuitton Lucine, Plastaras Laurianne, Bourreille Arnaud, Caillo Ludovic, Goutorbe Félix, Pineton De Chambrun Guillaume, Attar Alain, Roblin Xavier, Pereira Bruno, Fumery Mathurin
Université Clermont Auvergne, Inserm, Centre Hospitalier Universitaire Clermont-Ferrand, 3iHP, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France.
Université Clermont Auvergne, 3iHP, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France.
Inflamm Bowel Dis. 2023 Apr 3;29(4):579-588. doi: 10.1093/ibd/izac119.
Owing to growing number of therapeutic options with similar efficacy and safety, we compared the acceptability of therapeutic maintenance regimens in inflammatory bowel disease (IBD).
From a nationwide study (24 public or private centers), IBD patients were consecutively included for 6 weeks. A dedicated questionnaire including acceptability numerical scales (ANS) ranging from 0 to 10 (highest acceptability) was administered to both patients and related physicians.
Among 1850 included patients (65.9% with Crohn's disease), the ANS were 8.68 ± 2.52 for oral route (first choice in 65.8%), 7.67 ± 2.94 for subcutaneous injections (first choice in 21.4%), and 6.79 ± 3.31 for intravenous infusions (first choice in 12.8%; P < .001 for each comparison). In biologic-naïve patients (n = 315), the most accepted maintenance regimens were oral intake once (ANS = 8.8 ± 2.2) or twice (ANS = 6.9 ± 3.4) daily and subcutaneous injections every 12 or 8 weeks (ANS = 7.9 ± 3.0 and ANS = 7.2 ± 3.2, respectively). Among 342 patients with prior exposure to subcutaneous biologics, the preferred regimens were subcutaneous injections (≥2 week-intervals; ANS between 9.1 ± 2.3 and 8.1 ± 2.7) and oral intake once daily (ANS = 7.7 ± 3.2); although it was subcutaneous injections every 12 or 8 weeks (ANS = 8.4 ± 3.0 and ANS = 8.1 ± 3.0, respectively) and oral intake once daily (ANS = 7.6 ± 3.1) in case of prior exposure to intravenous biologics (n = 1181). The impact of usual therapeutic escalation or de-escalation was mild (effect size <0.5). From patients' acceptability perspective, superiority and noninferiority cutoff values should be 15% and 5%, respectively.
Although oral intake is overall preferred, acceptability is highly impacted by the rhythm of administration and prior medication exposures. However, SC treatment with long intervals between 2 injections (≥8 weeks) and oral intake once daily seems to be the most accepted modalities.
由于具有相似疗效和安全性的治疗选择越来越多，我们比较了炎症性肠病（IBD）治疗维持方案的可接受性。
在一项全国性研究（24个公立或私立中心）中，连续纳入IBD患者6周。向患者和相关医生发放了一份专门的问卷，其中包括从0到10（可接受性最高）的可接受性数字量表（ANS）。
在1850例纳入患者中（65.9%为克罗恩病），口服途径的ANS为8.68±2.52（65.8%的首选），皮下注射的ANS为7.67±2.94（21.4%的首选），静脉输注的ANS为6.79±3.31（12.8% 的首选；每次比较P <.001）。在未使用过生物制剂的患者（n = 315）中，最可接受的维持方案是每日口服一次（ANS = 8.8±2.2）或两次（ANS = 6.9±3.4）以及每12周或8周皮下注射一次（ANS分别为7.9±3.0和7.2±3.2）。在342例先前使用过皮下生物制剂的患者中, 首选方案是皮下注射（间隔≥2周；ANS在9.1±2.3至8.1±2.7之间）和每日口服一次（ANS = 7.7±3.2）；不过，在先前使用过静脉生物制剂的患者（n = 1181）中, 首选方案是每12周或8周皮下注射一次（ANS分别为8.4±3.0和8.1±3.0）和每日口服一次（ANS = 7.6±3.1）。常规治疗升级或降级的影响较小（效应大小<0.5）。从患者可接受性的角度来看，优效性和非劣效性临界值应分别为15%和5%。
虽然总体上首选口服，但可接受性受给药频率和先前用药情况的影响很大。然而，两次注射间隔时间长（≥8周）的皮下治疗和每日口服一次似乎是最可接受的方式。
