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
AU - Van Noord, Desirée
AU - Hoekstra, Jildou
AU - Kamphuis, Johannes T.
AU - Gorter, Moniek H.P.
AU - Van Esch, Aura A.J.
N1 - Publisher Copyright:
© 2023 The Author(s). Published by Oxford University Press on behalf of European Crohn's and Colitis Organisation.
PY - 2023/11
Y1 - 2023/11
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.
UR - https://www.scopus.com/pages/publications/85178495518
U2 - 10.1093/ecco-jcc/jjad101
DO - 10.1093/ecco-jcc/jjad101
M3 - Article
C2 - 37310877
AN - SCOPUS:85178495518
SN - 1873-9946
VL - 17
SP - 1771
EP - 1780
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
IS - 11
ER -
