TY - JOUR
T1 - Cost-effectiveness analysis of increased adalimumab dose intervals in Crohn's disease patients in stable remission
T2 - The Randomized Controlled LADI Trial
AU - Jansen, Fenna M
AU - van Linschoten, Reinier C A
AU - Kievit, Wietske
AU - Smits, Lisa J T
AU - Pauwels, Renske W M
AU - de Jong, Dirk J
AU - de Vries, Annemarie C
AU - Boekema, Paul J
AU - West, Rachel L
AU - Bodelier, Alexander G L
AU - Gisbertz, Ingrid A M
AU - Wolfhagen, Frank H J
AU - Römkens, Tessa E H
AU - Lutgens, Maurice W M D
AU - van Bodegraven, Adriaan A
AU - Oldenburg, Bas
AU - Pierik, Marieke J
AU - Russel, Maurice G V M
AU - de Boer, Nanne K
AU - Mallant-Hent, Rosalie C
AU - Ter Borg, Pieter C J
AU - van der Meulen-de Jong, Andrea E
AU - Jansen, Jeroen M
AU - Jansen, Sita V
AU - Tan, Adrianus C I T L
AU - Hoentjen, Frank
AU - van der Woude, C Janneke
N1 - Publisher Copyright:
© 2023 The Author(s). Published by Oxford University Press on behalf of European Crohn's and Colitis Organisation.
PY - 2023/11/24
Y1 - 2023/11/24
N2 - BACKGROUND AND AIMS: We aimed to assess cost-effectiveness of increasing adalimumab dose intervals compared to the conventional dosing interval in patients with Crohn's disease [CD] in stable clinical and biochemical remission.DESIGN: We conducted a pragmatic, open-label, randomized controlled non-inferiority trial, comparing increased adalimumab intervals with the 2-weekly interval in adult CD patients in clinical remission. Quality of life was measured with the EQ-5D-5L. Costs were measured from a societal perspective. Results are shown as differences and incremental net monetary benefit [iNMB] at relevant willingness to accept [WTA] levels.RESULTS: We randomized 174 patients to the intervention [n = 113] and control [n = 61] groups. No difference was found in utility (difference: -0.017, 95% confidence interval [-0.044; 0.004]) and total costs (-€943, [-€2226; €1367]) over the 48-week study period between the two groups. Medication costs per patient were lower (-€2545, [-€2780; -€2192]) in the intervention group, but non-medication healthcare (+€474, [+€149; +€952]) and patient costs (+€365 [+€92; €1058]) were higher. Cost-utility analysis showed that the iNMB was €594 [-€2099; €2050], €69 [-€2908; €1965] and -€455 [-€4,096; €1984] at WTA levels of €20 000, €50 000 and €80 000, respectively. Increasing adalimumab dose intervals was more likely to be cost-effective at WTA levels below €53 960 per quality-adjusted life year. Above €53 960 continuing the conventional dose interval was more likely to be cost-effective.CONCLUSION: When the loss of a quality-adjusted life year is valued at less than €53 960, increasing the adalimumab dose interval is a cost-effective strategy in CD patients in stable clinical and biochemical remission.CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, number NCT03172377.
AB - BACKGROUND AND AIMS: We aimed to assess cost-effectiveness of increasing adalimumab dose intervals compared to the conventional dosing interval in patients with Crohn's disease [CD] in stable clinical and biochemical remission.DESIGN: We conducted a pragmatic, open-label, randomized controlled non-inferiority trial, comparing increased adalimumab intervals with the 2-weekly interval in adult CD patients in clinical remission. Quality of life was measured with the EQ-5D-5L. Costs were measured from a societal perspective. Results are shown as differences and incremental net monetary benefit [iNMB] at relevant willingness to accept [WTA] levels.RESULTS: We randomized 174 patients to the intervention [n = 113] and control [n = 61] groups. No difference was found in utility (difference: -0.017, 95% confidence interval [-0.044; 0.004]) and total costs (-€943, [-€2226; €1367]) over the 48-week study period between the two groups. Medication costs per patient were lower (-€2545, [-€2780; -€2192]) in the intervention group, but non-medication healthcare (+€474, [+€149; +€952]) and patient costs (+€365 [+€92; €1058]) were higher. Cost-utility analysis showed that the iNMB was €594 [-€2099; €2050], €69 [-€2908; €1965] and -€455 [-€4,096; €1984] at WTA levels of €20 000, €50 000 and €80 000, respectively. Increasing adalimumab dose intervals was more likely to be cost-effective at WTA levels below €53 960 per quality-adjusted life year. Above €53 960 continuing the conventional dose interval was more likely to be cost-effective.CONCLUSION: When the loss of a quality-adjusted life year is valued at less than €53 960, increasing the adalimumab dose interval is a cost-effective strategy in CD patients in stable clinical and biochemical remission.CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, number NCT03172377.
KW - Adalimumab
KW - Crohn's disease
KW - dose de-escalation
UR - http://www.scopus.com/inward/record.url?scp=85178495518&partnerID=8YFLogxK
U2 - 10.1093/ecco-jcc/jjad101
DO - 10.1093/ecco-jcc/jjad101
M3 - Article
C2 - 37310877
SN - 1873-9946
VL - 17
SP - 1771
EP - 1780
JO - Journal of Crohn's & Colitis
JF - Journal of Crohn's & Colitis
IS - 11
ER -