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Practice Rapid Recommendations

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

BMJ 2024; 387 doi: https://doi.org/10.1136/bmj-2024-079830 (Published 28 October 2024) Cite this as: BMJ 2024;387:e079830
Visual summary of recommendations
Population These recommendations apply only to people with these characteristics: Adults with immune-mediated inflammatory diseases Being treated with or starting treatment with infliximab, adalimumab, or other biologic drugs May or may not apply to: other immune-mediated inflammatory diseases Does not apply to: Inflammatory diseases that are not immune-mediated Inflammatory arthritis Inflammatory bowel disease Psoriasis Rheumatoid arthritis Spondyloarthritis Psoriatic arthritis
Recommendation 1
Standard careReactive or no monitoringProactive monitoringorAdults receiving maintenancetherapy with infliximabWe suggest proactive therapeutic drug monitoringStrongAll or nearly all informed people would likelywant the intervention to the left. Benefitswould outweigh harms for almost everyoneWeakMost people would likely want the interventionto the left. Benefits would outweigh harms forthe majority, but not for everyoneWeakMost people would likely want the interventionto the right. Benefits would outweigh harmsfor the majority, but not for everyoneStrongAll or nearly all informed people would likelywant the intervention to the right. Benefitswould outweigh harms for almost everyone

Evidence profile

Favours standard careFavours proactive monitoringNo important differenceThe panel found that this difference was not important for most patients,because the intervention effects were negligible and/or very imprecise, forexample confidence intervals that include both important benefit and harm
Events per 1000 peopleEvidence quality

Disease control and/or remission140 more560700LowMore

Based on data from 760 patients in 3 studiesProactive therapeutic drug monitoringmay increase the proportion of patientswho experience sustained diseasecontrol, sustained remission, or bothLowGRADE rating,because of:Risk of biasSeriousImprecisionNo serious concernsIndirectnessSeriousInconsistencyNo serious concernsPublication biasNo serious concernsGRADE certainty ratingsHighThe authors have a lot ofconfidence that the trueeffect is similar to theestimated effectModerateThe authors believe thatthe true effect is probablyclose to theestimated effectLowThe true effect might bemarkedly different fromthe estimated effectVery lowThe true effect isprobably markedlydifferent from theestimated effect

Discontinuation due to adverse...No important difference5048Very lowMore

Based on data from 705 patients in 2 studiesIt is unclear if proactive therapeuticdrug monitoring has an effect on adverseevents leading to discontinuation oftherapyVery lowGRADE rating,because of:Risk of biasNo serious concernsImprecisionVery seriousIndirectnessSeriousInconsistencyNo serious concernsPublication biasNo serious concernsGRADE certainty ratingsHighThe authors have a lot ofconfidence that the trueeffect is similar to theestimated effectModerateThe authors believe thatthe true effect is probablyclose to theestimated effectLowThe true effect might bemarkedly different fromthe estimated effectVery lowThe true effect isprobably markedlydifferent from theestimated effect

Serious adverse eventsNo important difference8078Very lowMore

Based on data from 785 patients in 3 studiesIt is unclear if proactive therapeuticdrug monitoring has any effect onserious adverse eventsVery lowGRADE rating,because of:Risk of biasSeriousImprecisionSeriousIndirectnessSeriousInconsistencyNo serious concernsPublication biasNo serious concernsGRADE certainty ratingsHighThe authors have a lot ofconfidence that the trueeffect is similar to theestimated effectModerateThe authors believe thatthe true effect is probablyclose to theestimated effectLowThe true effect might bemarkedly different fromthe estimated effectVery lowThe true effect isprobably markedlydifferent from theestimated effect
See all outcomes
Patient decision aids

Individual considerations

Key practical issuesStandard careProactive monitoringRequires access to laboratory with validated analyses of infliximab serum drug levels and anti-drug antibodiesDrug dosing is adjusted to keep serum drug levels in apre-defined therapeutic range, typically by using analgorithmThere is little evidence on how often proactive monitoringshould be done to be beneficialReactive therapeutic drug monitoring or no therapeuticdrug monitoring
Values and preferencesThere was no evidence about how individuals with an immune mediatedinflammatory disease would judge the success of proactive monitoring. Anassumption was made that most patients would value proactive monitoring if itincreased sustained disease control, sustained remission, or both by 5% withoutcausing additional serious harm
Recommendation 2
Standard careReactive or no monitoringProactive monitoringorAdults receiving maintenancetherapy with adalimumab andother biologicsWe suggest not using proactive therapeutic drugmonitoringStrongAll or nearly all informed people would likelywant the intervention to the left. Benefitswould outweigh harms for almost everyoneWeakMost people would likely want the interventionto the left. Benefits would outweigh harms forthe majority, but not for everyoneWeakMost people would likely want the interventionto the right. Benefits would outweigh harmsfor the majority, but not for everyoneStrongAll or nearly all informed people would likelywant the intervention to the right. Benefitswould outweigh harms for almost everyone

Evidence profile - data only on adalimumab

Favours standard careFavours proactive monitoringNo important differenceThe panel found that this difference was not important for most patients,because the intervention effects were negligible and/or very imprecise, forexample confidence intervals that include both important benefit and harm
Events per 1000 peopleEvidence quality

Disease control and/or remission403 more560963Very lowMore

Based on data from 78 patients in 1 studyIt is unclear if proactive therapeuticdrug monitoring affects the proportionof patients who experience sustaineddisease control, sustained remission, orbothVery lowGRADE rating,because of:Risk of biasSeriousImprecisionSeriousIndirectnessSeriousInconsistencyNo serious concernsPublication biasNo serious concernsGRADE certainty ratingsHighThe authors have a lot ofconfidence that the trueeffect is similar to theestimated effectModerateThe authors believe thatthe true effect is probablyclose to theestimated effectLowThe true effect might bemarkedly different fromthe estimated effectVery lowThe true effect isprobably markedlydifferent from theestimated effect

Discontinuation due to adverse...No important difference5054Very lowMore

Based on data from 1053 patients in 3 studiesProactive therapeutic drug monitoringmay have no effect on adverse eventsleading to discontinuationVery lowGRADE rating,because of:Risk of biasNo serious concernsImprecisionVery seriousIndirectnessSeriousInconsistencyNo serious concernsPublication biasNo serious concernsGRADE certainty ratingsHighThe authors have a lot ofconfidence that the trueeffect is similar to theestimated effectModerateThe authors believe thatthe true effect is probablyclose to theestimated effectLowThe true effect might bemarkedly different fromthe estimated effectVery lowThe true effect isprobably markedlydifferent from theestimated effect

Serious adverse events19 fewer8061Very lowMore

Based on data from 1053 patients in 3 studiesIt is unclear if proactive therapeuticdrug monitoring reduces the proportionof patients who experience seriousadverse eventsVery lowGRADE rating,because of:Risk of biasNo serious concernsImprecisionVery seriousIndirectnessSeriousInconsistencyNo serious concernsPublication biasNo serious concernsGRADE certainty ratingsHighThe authors have a lot ofconfidence that the trueeffect is similar to theestimated effectModerateThe authors believe thatthe true effect is probablyclose to theestimated effectLowThe true effect might bemarkedly different fromthe estimated effectVery lowThe true effect isprobably markedlydifferent from theestimated effect
See all outcomes (adalimumab)
See all outcomes (other biologics)
Patient decision aids

Individual considerations

Key practical issuesStandard careProactive monitoringProactive therapeutic drug monitoring of adalimumab andother biologics involves regularly measuring serum druglevels and anti-drug antibodiesReactive therapeutic drug monitoring or no therapeuticdrug monitoring
Values and preferencesThere was no evidence about how individuals with an immune mediatedinflammatory disease would judge the success of proactive monitoring. Anassumption was made that most patients would prefer standard care, given the verylow certainty of the evidence informing this recommendation
Recommendation 3
Standard careReactive or no monitoringProactive monitoringorAdults starting therapy withinfliximab, adalimumab, andother biologicsWe suggest not using proactive therapeutic drugmonitoringStrongAll or nearly all informed people would likelywant the intervention to the left. Benefitswould outweigh harms for almost everyoneWeakMost people would likely want the interventionto the left. Benefits would outweigh harms forthe majority, but not for everyoneWeakMost people would likely want the interventionto the right. Benefits would outweigh harmsfor the majority, but not for everyoneStrongAll or nearly all informed people would likelywant the intervention to the right. Benefitswould outweigh harms for almost everyone

Evidence profile - data only on infliximab

Favours standard careFavours proactive monitoringNo important differenceThe panel found that this difference was not important for most patients,because the intervention effects were negligible and/or very imprecise, forexample confidence intervals that include both important benefit and harm
Events per 1000 peopleEvidence quality

RemissionNo important difference530504Very lowMore

Based on data from 398 patients in 1 studyProactive therapeutic drug monitoringmay have little or no effect onachieving remission.Very lowGRADE rating,because of:Risk of biasSeriousImprecisionSeriousIndirectnessSeriousInconsistencyNo serious concernsPublication biasNo serious concernsGRADE certainty ratingsHighThe authors have a lot ofconfidence that the trueeffect is similar to theestimated effectModerateThe authors believe thatthe true effect is probablyclose to theestimated effectLowThe true effect might bemarkedly different fromthe estimated effectVery lowThe true effect isprobably markedlydifferent from theestimated effect

Discontinuation due to adverse...No important difference8054Very lowMore

Based on data from 520 patients in 2 studiesProactive therapeutic drug monitoringmay have little or no effect on adverseevents leading to discontinuation oftherapy.Very lowGRADE rating,because of:Risk of biasSeriousImprecisionSeriousIndirectnessSeriousInconsistencyNo serious concernsPublication biasNo serious concernsGRADE certainty ratingsHighThe authors have a lot ofconfidence that the trueeffect is similar to theestimated effectModerateThe authors believe thatthe true effect is probablyclose to theestimated effectLowThe true effect might bemarkedly different fromthe estimated effectVery lowThe true effect isprobably markedlydifferent from theestimated effect

Serious adverse eventsNo important difference100115Very lowMore

Based on data from 520 patients in 2 studiesProactive therapeutic drug monitoringmay have little or no effect on seriousadverse events.Very lowGRADE rating,because of:Risk of biasSeriousImprecisionSeriousIndirectnessSeriousInconsistencyNo serious concernsPublication biasNo serious concernsGRADE certainty ratingsHighThe authors have a lot ofconfidence that the trueeffect is similar to theestimated effectModerateThe authors believe thatthe true effect is probablyclose to theestimated effectLowThe true effect might bemarkedly different fromthe estimated effectVery lowThe true effect isprobably markedlydifferent from theestimated effect
See all outcomes (infliximab)
See all outcomes (adalimumab and other biologics)
Patient decision aids

Individual considerations

Key practical issuesStandard careProactive monitoringProactive therapeutic drug monitoring of infliximabinvolves regularly measuring serum drug levels andanti-drug antibodiesReactive therapeutic drug monitoring or no therapeuticdrug monitoring
Values and preferencesThere was no evidence about how individuals with an immune mediatedinflammatory disease would judge the success of proactive monitoring. Anassumption was made that most patients would prefer standard care, given the verylow certainty of the evidence informing this recommendation

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