Proactive therapeutic drug monitoring of biologic drugs in adult patients with inflammatory bowel disease, inflammatory arthritis, or psoriasis: a clinical practice guideline

作者：Letícia Kawano-Dourado, Eirik Klami Kristianslund, Dena Zeraatkar, Meghna Jani, Govind Makharia, Glen Hazlewood, Catherine Smith, Tine Jess, Camilla Stabell, Arne Schatten, Andrew Owen, Johanna Elin Gehin, Leolin Katsidzira, David S. Weinberg, Iazsmin Bauer-Ventura, Peter Tugwell, Paul Moayyedi, Ana Veronica Wolff Cecchi, Andrea Yukie Shimabuco, Siri Seterelv, Gordon Gyuatt, Thomas Agoritsas, Per Olav Vandvik · 发表于：BMJ · 年份：2024 · DOI：10.1136/bmj-2024-079830 · 被引用次数：20 · 研究领域：Biosimilars and Bioanalytical Methods、Rheumatoid Arthritis Research and Therapies、Inflammatory Bowel Disease

CLINICAL QUESTION: In adult patients with inflammatory bowel disease, inflammatory arthritis (rheumatoid arthritis, spondyloarthritis, psoriatic arthritis), or psoriasis taking biologic drugs, does proactive therapeutic drug monitoring (TDM) improve outcomes as compared with standard care? CONTEXT AND CURRENT PRACTICE: Standard care for immune mediated inflammatory diseases includes prescribing biologic drugs at pre-determined doses. Dosing may be adjusted reactively, for example with increased disease activity. In proactive TDM, serum drug levels and anti-drug antibodies are measured irrespective of disease activity, and the drug dosing is adjusted to achieve target serum drug levels, usually within pre-specified therapeutic ranges. The role of proactive TDM in clinical practice remains unclear, with conflicting guideline recommendations and emerging evidence from randomised controlled trials. THE EVIDENCE: Linked systematic review and pairwise meta-analysis which identified 10 trials including 2383 participants. Inflammatory bowel disease, inflammatory arthritis, and psoriasis were grouped together as best current research evidence on proactive TDM did not suggest heterogeneity of effects on outcomes of interest. Proactive TDM of intravenous infliximab during maintenance treatment may increase the proportion of patients who experience sustained disease control or sustained remission without considerable additional harm. For adalimumab, it remains unclear if proactive TDM du...