Effect of Therapeutic Drug Monitoring vs Standard Therapy During Infliximab Induction on Disease Remission in Patients With Chronic Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial.
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Syversen Silje Watterdal, Goll Guro Løvik, Jørgensen Kristin Kaasen, Sandanger Øystein, Sexton Joseph, Olsen Inge Christoffer, Gehin Johanna Elin, Warren David John, Brun Marthe Kirkesæther, Klaasen Rolf Anton, Karlsen Lars Normann, Noraberg Geir, Zettel Camilla, Ljoså Maud Kristine Aga, Haugen Anne Julsrud, Njålla Rune Johan, Bruun Trude Jannecke, Seeberg Kathrine Aglen, Michelsen Brigitte, Strand Eldri Kveine, Skorpe Svanaug, Blomgren Ingrid Marianne, Bragnes Yngvill Hovde, Dotterud Christian Kvikne, Thune Turid, Ystrøm Carl Magnus, Torp Roald, Mielnik Pawel, Mørk Cato, Kvien Tore K, Jahnsen Jørgen, Bolstad Nils, Haavardsholm Espen A
Аннотация
OBJECTIVE: To assess whether TDM during initiation of infliximab therapy improves treatment efficacy compared with standard infliximab therapy without TDM.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, parallel-group, open-label clinical trial of 411 adults with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn disease, or psoriasis initiating infliximab therapy in 21 hospitals in Norway. Patients were recruited from March 1, 2017, to January 10, 2019. Final follow-up occurred on November 5, 2019.
INTERVENTIONS: Patients were randomized 1:1 to receive proactive TDM with dose and interval adjustments based on scheduled monitoring of serum drug levels and antidrug antibodies (TDM group; n = 207) or standard infliximab therapy without drug and antibody level monitoring (standard therapy group; n = 204).
MAIN OUTCOMES AND MEASURES: The primary end point was clinical remission at week 30.
RESULTS: Among 411 randomized patients (mean age, 44.7 [SD, 14.9] years; 209 women [51%]), 398 (198 in the TDM group and 200 in the standard therapy group) received their randomized intervention and were included in the full analysis set. Clinical remission at week 30 was achieved in 100 (50.5%) of 198 and 106 (53.0%) of 200 patients in the TDM and standard therapy groups, respectively (adjusted difference, 1.5%; 95% CI, -8.2% to 11.1%; P = .78). Adverse events were reported in 135 patients (68%) and 139 patients (70%) in the TDM and standard therapy groups, respectively.
CONCLUSIONS AND RELEVANCE: Among patients with immune-mediated inflammatory diseases initiating treatment with infliximab, proactive therapeutic drug monitoring, compared with standard therapy, did not significantly improve clinical remission rates over 30 weeks. These findings do not support routine use of therapeutic drug monitoring during infliximab induction for improving disease remission rates.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03074656.