Real-world data on switching from intravenous to subcutaneous vedolizumab treatment in patients with inflammatory bowel disease

被引:42
作者
Bergqvist, Viktoria [1 ,2 ]
Holmgren, Johanna [1 ,2 ]
Klintman, Daniel [1 ,2 ]
Marsal, Jan [1 ,2 ,3 ]
机构
[1] Skane Univ Hosp, Dept Gastroenterol, SE-22185 Lund, Sweden
[2] Lund Univ, Dept Clin Sci, Sect Med, Lund, Sweden
[3] Lund Univ, Dept Expt Med Sci, Sect Immunol, Lund, Sweden
关键词
REPORTED OUTCOME MEASURES; SHORT HEALTH SCALE; FECAL CALPROTECTIN; CROHNS-DISEASE; SURROGATE MARKERS; SUBJECTIVE HEALTH; CLINICAL-TRIAL; RELAPSE; NONADHERENCE; THERAPY;
D O I
10.1111/apt.16927
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background and Aims Vedolizumab is a gut-selective treatment approved for Crohn's disease (CD) and ulcerative colitis (UC). Recently, a subcutaneous formulation of vedolizumab was approved. The aims of this study were to evaluate efficacy, safety, pharmacokinetics, patient experience and costs following a switch from intravenous to subcutaneous vedolizumab treatment. Methods Patients were switched from intravenous to subcutaneous vedolizumab maintenance treatment and followed prospectively for 6 months and a subgroup for 12 months. The primary endpoint was change in faecal calprotectin levels. Furthermore, we evaluated clinical disease activity, remission rates, plasma CRP, drug persistence, adverse events, local injection reactions, serum drug concentrations, patient satisfaction, quality-of-life and treatment costs. Results Eighty-nine patients were included (48 CD; 41 UC). Faecal calprotectin decreased significantly in CD but not in UC. Clinical indices, remission rates, plasma CRP levels and quality-of-life scores remained unchanged. Patients that had been on standard compared to optimised IV vedolizumab dosing displayed similar outcomes on standard SC dosing. Drug persistence at 6 and 12 months was 95.5% and 88.5%, respectively. Frequencies of adverse events were similar before and after the switch. No serious adverse events occurred. Transient severe local injection reactions were experienced by 1.2% of patients. Median vedolizumab trough levels were 2.3 times higher on subcutaneous compared to intravenous treatment. Patient satisfaction was generally high. Annualised treatment costs were reduced by 15% following the switch. Conclusions The switch from intravenous to subcutaneous vedolizumab could be done with preserved therapeutic effectiveness, safety, high patient satisfaction and low discontinuation rate, at a reduced cost.
引用
收藏
页码:1389 / 1401
页数:13
相关论文
共 48 条
[1]   Surrogate markers and clinical indices, alone or combined, as indicators for endoscopic remission in anti-TNF-treated luminal Crohn's disease [J].
af Bjorkesten, Clas-Goran ;
Nieminen, Urpo ;
Turunen, Ulla ;
Arkkila, Perttu ;
Sipponen, Taina ;
Farkkila, Martti .
SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY, 2012, 47 (05) :528-537
[2]   How do patients with inflammatory bowel disease want their biological therapy administered? [J].
Allen, Patrick B. ;
Lindsay, Hannah ;
Tham, Tony C. K. .
BMC GASTROENTEROLOGY, 2010, 10
[3]  
[Anonymous], 2014, ENTYVIO (vedolizumab) [package insert]
[4]   Vedolizumab for perianal fistulizing Crohn's disease: systematic review and meta-analysis [J].
Ayoub, Fares ;
Odenwald, Matthew ;
Micic, Dejan ;
Dalal, Sushila R. ;
Pekow, Joel ;
Cohen, Russell D. ;
Rubin, David T. ;
Sakuraba, Atsushi .
INTESTINAL RESEARCH, 2022, 20 (02) :240-+
[5]   Fecal Calprotectin Is Highly Effective to Detect Endoscopic Ulcerations in Crohn's Disease Regardless of Disease Location [J].
Buisson, Anthony ;
Mak, Wing Yan ;
Andersen, Michael J. ;
Lei, Donald ;
Pekow, Joel ;
Cohen, Russell D. ;
Kahn, Stacy A. ;
Pereira, Bruno ;
Rubin, David T. .
INFLAMMATORY BOWEL DISEASES, 2021, 27 (07) :1008-1016
[6]   Vedolizumab for perianal Crohn's disease: a multicentre cohort study in 151 patients [J].
Chapuis-Biron, Constance ;
Bourrier, Anne ;
Nachury, Maria ;
Nancey, Stephane ;
Bouhnik, Yoram ;
Serrero, Melanie ;
Armengol-Debeir, Laura ;
Buisson, Anthony ;
Tran-Minh, My-Linh ;
Zallot, Camille ;
Fumery, Mathurin ;
Bouguen, Guillaume ;
Abitbol, Vered ;
Viennot, Stephanie ;
Chanteloup, Elise ;
Rajca, Sylvie ;
Dib, Nina ;
Parmentier, Anne-Laure ;
Peyrin-Biroulet, Laurent ;
Vuitton, Lucine .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2020, 51 (07) :719-727
[7]   The safety of vedolizumab for ulcerative colitis and Crohn's disease [J].
Colombel, Jean-Frederic ;
Sands, Bruce E. ;
Rutgeerts, Paul ;
Sandborn, William ;
Danese, Silvio ;
D'Haens, Geert ;
Panaccione, Remo ;
Loftus, Edward V., Jr. ;
Sankoh, Serap ;
Fox, Irving ;
Parikh, Asit ;
Milch, Catherine ;
Abhyankar, Brihad ;
Feagan, Brian G. .
GUT, 2017, 66 (05) :839-851
[8]   Consecutive Fecal Calprotectin Measurements to Predict Relapse in Patients with Ulcerative Colitis Receiving Infliximab Maintenance Therapy [J].
De Vos, Martine ;
Louis, Edouard J. ;
Jahnsen, Jorgen ;
Vandervoort, Jo G. P. ;
Noman, Maja ;
Dewit, Olivier ;
D'Haens, Geert R. ;
Franchimont, Denis ;
Baert, Filip J. ;
Torp, Roald A. ;
Henriksen, Magne ;
Potvin, Philippe M. R. ;
Van Hootegem, Philippe P. ;
Hindryckx, Pieter M. ;
Moreels, Tom G. ;
Collard, Arnaud ;
Karlsen, Lars Normann ;
Kittang, Eirik ;
Lambrecht, Guy ;
Grimstad, Tore ;
Koch, Jonas ;
Lygren, Idar ;
Coche, Jean-Claude R. J. ;
Mana, Fazia ;
Van Gossum, Andre ;
Belaiche, Jacques ;
Cool, Mike R. ;
Fontaine, Fernand ;
Maisin, Jean-Marc G. ;
Muls, Vinciane ;
Neuville, Bart ;
Staessen, Dirk A. J. ;
Van Assche, Gert A. ;
de Lange, Thomas ;
Solberg, Inger Camilla ;
Vander Cruyssen, Bert J. K. ;
Vermeire, Severine A. R. A. .
INFLAMMATORY BOWEL DISEASES, 2013, 19 (10) :2111-2117
[9]   Satisfaction with Subcutaneous Golimumab and its Auto-Injector among Rheumatoid Arthritis Patients with Inadequate Response to Adalimumab or Etanercept [J].
Dehoratius, Raphael J. ;
Brent, Lawrence H. ;
Curtis, Jeffrey R. ;
Ellis, Lorie A. ;
Tang, Kezhen L. .
PATIENT-PATIENT CENTERED OUTCOMES RESEARCH, 2018, 11 (03) :361-369
[10]   Usability of a novel disposable autoinjector device for ixekizumab: results from a qualitative study and an open-label clinical trial, including patient-reported experience [J].
Duffin, Kristina Callis ;
Bukhalo, Michael ;
Bobonich, Margaret A. ;
Shrom, David ;
Zhao, Fangyi ;
Kershner, James R. ;
Gill, Anne ;
Pangallo, Beth ;
Shuler, Catherine L. ;
Bagel, Jerry .
MEDICAL DEVICES-EVIDENCE AND RESEARCH, 2016, 9 :361-369