Abstract
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?
Context and current practice
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 use of proactive TDM in clinical practice remains unclear, with conflicting guideline recommendations based on emerging evidence from randomised controlled trials..
Recommendations
The guideline panel issued the following recommendations for patients with inflammatory bowel disease, inflammatory arthritis, and psoriasis:
1. A weak recommendation in favour of proactive TDM for intravenous infliximab during maintenance treatment
2. A weak recommendation against proactive TDM for adalimumab and other biologic drugs during maintenance treatment
3. A weak recommendation against proactive TDM for intravenous infliximab, adalimumab, and other biologic drugs during induction (start) of treatment
Understanding the recommendations
The three diseases were grouped together as best current research evidence on proactive TDM did not suggest heterogeneity of effects on the 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 during maintenance treatment has an effect on sustained disease control or sustained remission. In the induction (start) of treatment, proactive TDM of intravenous infliximab may have little or no effect on achieving remission. There was no eligible trial evidence available for proactive TDM of adalimumab in induction of treatment nor for other biologic drugs in maintenance and in induction (start) of treatment. When considering proactive TDM, clinicians and patients should engage in shared decision-making to ensure patients make choices that reflect their values and preferences. The availability of laboratory assays to implement proactive TDM should also be considered. Further research is warranted and may alter recommendations in the future.
How this guideline was created
An international panel including patient partners, clinicians, and methodologists produced these recommendations based on a linked systematic review and pairwise meta-analysis which identified eight trials including 2,032 participants. The panel followed standards for trustworthy guidelines and used the GRADE approach, explicitly considering the balance of benefits and harms and burdens of treatment with an individual patient perspective.
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?
Context and current practice
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 use of proactive TDM in clinical practice remains unclear, with conflicting guideline recommendations based on emerging evidence from randomised controlled trials..
Recommendations
The guideline panel issued the following recommendations for patients with inflammatory bowel disease, inflammatory arthritis, and psoriasis:
1. A weak recommendation in favour of proactive TDM for intravenous infliximab during maintenance treatment
2. A weak recommendation against proactive TDM for adalimumab and other biologic drugs during maintenance treatment
3. A weak recommendation against proactive TDM for intravenous infliximab, adalimumab, and other biologic drugs during induction (start) of treatment
Understanding the recommendations
The three diseases were grouped together as best current research evidence on proactive TDM did not suggest heterogeneity of effects on the 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 during maintenance treatment has an effect on sustained disease control or sustained remission. In the induction (start) of treatment, proactive TDM of intravenous infliximab may have little or no effect on achieving remission. There was no eligible trial evidence available for proactive TDM of adalimumab in induction of treatment nor for other biologic drugs in maintenance and in induction (start) of treatment. When considering proactive TDM, clinicians and patients should engage in shared decision-making to ensure patients make choices that reflect their values and preferences. The availability of laboratory assays to implement proactive TDM should also be considered. Further research is warranted and may alter recommendations in the future.
How this guideline was created
An international panel including patient partners, clinicians, and methodologists produced these recommendations based on a linked systematic review and pairwise meta-analysis which identified eight trials including 2,032 participants. The panel followed standards for trustworthy guidelines and used the GRADE approach, explicitly considering the balance of benefits and harms and burdens of treatment with an individual patient perspective.
| Original language | English |
|---|---|
| Journal | BMJ. |
| Publication status | Accepted/In press - 23 Aug 2024 |