Clinical consequences of infliximab immunogenicity and the effect of proactive therapeutic drug monitoring: exploratory analyses of the randomised, controlled NOR-DRUM trials
Primary result · RemissionResult — go to the resultRR for remission 0.62 95% CI 0.45–0.86Authors' conclusion
In patients where antidrug antibodies were detected, remission was less likely to be reached and sustained, and infusion reaction or discontinuation of infliximab was more likely.
Study context
- Population
- Adults (18–75 years) with IMIDs on infliximab, rheumatology, gastroenterology and dermatology departments at 21 Norwegian hospitals, NOR-DRUM A (30-week follow-up) and B (52-week follow-up) trialsof 616 included in the trials
- Participants
- 615 adults
- Comparison
- Patients with vs without antidrug antibodies to infliximab; proactive therapeutic drug monitoring vs standard infliximab dosing
- With antidrug antibodiesn = 147
- Primary endpoint
- Remission according to the presence of antidrug antibodies
- Follow-up
- Week 30
Methodological detailspredefined exploratory analysis, multicentre, Included March 1, 2017, to Dec 12, 2019
- Predefined exploratory analysis
- Multicentre
- Included March 1, 2017, to Dec 12, 2019
Primary result
Remission
RR for remission
0.62
95% CI 0.45–0.86
P = 0.0037
Events by treatment group
Antidrug antibodiesvs No antidrug antibodies
RR for remission 0.62 (95% CI 0.45–0.86); P = 0.0037
As reported in the abstract
Further findings
Rate, per person-year
| Outcome | With antidrug antibodies | Estimate | P value | |
|---|---|---|---|---|
| Disease worsening over 52 weeksAntidrug antibodiesvs No antidrug antibodies | 0.76 | HR for disease worsening 2.02 (95% CI 1.33–3.07) | P = 0.0009 | |
| Infliximab discontinuationAntidrug antibodiesvs No antidrug antibodies | 1.00 | HR for infliximab discontinuation 6.64 (CI 4.84–9.11) | P < 0.0001 | |
| 0.10.31310Ratio (log scale) |
- Disease worsening over 52 weeks: No antidrug antibodies rate 0· 35 per person-year
- Infliximab discontinuation: No antidrug antibodies rate 0.20 per person-year
Disease worsening with therapeutic drug monitoring, independent of antibody status
- Therapeutic drug monitoring associated with lower risk of disease worsening: HR
- 0.41 [0.29-0.59]; p=0.0001
Infliximab discontinuation with therapeutic drug monitoring, independent of antibody status
- Therapeutic drug monitoring associated with increased rate of infliximab discontinuation: HR
- 1.37 [1.02-1.83]; p=0.037
Safety
| Outcome | With antidrug antibodies | HR for infusion reaction (CI) | P value | |
|---|---|---|---|---|
| Infusion reactionsAntidrug antibodiesvs No antidrug antibodies | rate 0.16 per person-year | 17.02 (6.98–41.47) | P < 0.0001 | |
| 0.050.21520HR for infusion reaction (log scale) |
- Infusion reactions: No antidrug antibodies rate 0.03 per person-year
Infusion reaction with therapeutic drug monitoring, independent of antibody status
- Therapeutic drug monitoring associated with lower risk of an infusion reaction: HR
- 0.30 [0.12-0.73]; p=0.0076
Original publication
Clinical consequences of infliximab immunogenicity and the effect of proactive therapeutic drug monitoring: exploratory analyses of the randomised, controlled NOR-DRUM trials. Lancet Rheumatol. Published 22 February 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →