Individualised therapy is more cost-effective than dose intensification in patients with Crohn’s disease who lose response to anti-TNF treatment: a randomised, controlled trial

Steenholdt, Casper; Brynskov, Jørn; Thomsen, Ole Østergaard; Munck, Lars Kristian; Fallingborg, Jan; Christensen, Lisbet Ambrosius; Pedersen, G.; Kjeldsen, Jens; Jacobsen, Bent Ascanius; Oxholm, Anne Sophie; Kjellberg, Jakob; Bendtzen, Klaus; Ainsworth, Mark

doi:10.1136/gutjnl-2013-305279

Cited by 419 publications

(348 citation statements)

References 26 publications

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“…Two were randomized controlled trials [14,18], and five used a modeling approach (three used a Markov model [16,17,19] and two a discrete event model [20,22]). Four studies included only CD patients [18][19][20]22], one included both CD and UC patients [14], and two only RA patients [16,17].…”

Section: Resultsmentioning

confidence: 99%

Cost-effectiveness of drug monitoring of anti-TNF therapy in inflammatory bowel disease and rheumatoid arthritis: a systematic review

et al. 2016

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Background Therapeutic drug monitoring (TDM) of anti-TNF is increasingly used to manage inflammatory bowel diseases (IBD) and rheumatoid arthritis (RA). The costeffectiveness of this strategy is debated. Methods All studies comparing the cost-effectiveness of a TDM-based strategy and an empirical dose management of anti-TNF in IBD or RA were screened. Studies were identified through the MEDLINE electronic database (up to July 2016), and annual international meeting abstracts were also manually reviewed. Results Seven studies were included: two randomized controlled trials (RCTs) enrolling 332 patients [247 Crohn's disease (CD) and 85 ulcerative colitis (UC)] and five modeling approaches. Four studies included only CD patients, one included both CD and UC patients, and two included only RA patients. Three studies compared the cost-effectiveness of the two strategies in patients with secondary infliximab (IFX) failure (dose-escalation strategy), one in patients in remission on optimized IFX (deescalation strategy), one in patients starting adalimumab, and two in patients with clinical response to maintenance anti-TNF therapy. The two RCTs demonstrated that a TDM strategy led to major cost savings, ranging from 28 to 34 %. The three modeling approaches with regard to CD patients demonstrated cost savings ranging from $5396 over a 1-year period to €13,130 per patient at 5 years of follow-up. A TDM strategy also led to major cost savings in the two modeling approaches in RA patients. Conclusions Available evidence indicates that a TDM strategy leads to major cost savings related to anti-TNF therapy in both IBD and RA patients, with no negative impact on efficacy.

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Section: Resultsmentioning

confidence: 99%

Cost-effectiveness of drug monitoring of anti-TNF therapy in inflammatory bowel disease and rheumatoid arthritis: a systematic review

et al. 2016

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“…Secondary loss-of-response to infliximab was defined as recurrence of active disease with a Crohn's disease activity index (CDAI) C220 and/or a minimum of one draining perianal fistula. In a prior publication, the authors reported superior economic outcomes and similar clinical outcomes for the TDM-based intervention arm versus the doseescalation arm at week 12 [5]. Here, the authors provide longer follow-up and report that cost savings are maintained throughout week 20 and the first year of follow-up, with similar clinical outcomes observed in both groups.…”

mentioning

confidence: 50%

“…Although the threshold drug concentration of 0.5 lg/ml is generally considered to be low, using higher thresholds made no difference according to a sensitivity analysis included in their original publication [5]. Nonetheless, an objective measure could have been used to confirm disease activity in the subpopulation of patients with ''adequate'' drug exposure, since the recommended TDM-based intervention for overcoming loss-ofresponse in this subgroup was to change to a different class of therapy, a consequential decision due to the limited salvage options available.…”

mentioning

confidence: 99%

Preemptive Dose Optimization Using Therapeutic Drug Monitoring for Biologic Therapy of Crohn’s Disease: Avoiding Failure While Lowering Costs?

Casteele

Gils

2015

Dig Dis Sci

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“…Further, dose optimization can reduce over-and under-treatment. Greater understanding of pharmacokinetics is leading to individualized drug dosing that is cost saving and clinically efficient [118,119]. Furthermore, targeting objective disease outcomes also improves effective drug dosing and costeffectiveness [120].…”

Section: Pharmacoeconomic Considerations Of Biological Therapymentioning

confidence: 99%

The Impact of Therapeutic Antibodies on the Management of Digestive Diseases: History, Current Practice, and Future Directions

Sofia

Rubin

2017

Dig Dis Sci

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The development of therapeutic antibodies represents a revolutionary change in medical therapy for digestive diseases. Beginning with the initial studies that confirmed the pathogenicity of cytokines in inflammatory bowel disease, the development and application of therapeutic antibodies brought challenges and insights into their potential and optimal use. Infliximab was the first biological drug approved for use in Crohn's disease and ulcerative colitis. The lessons learned from infliximab include the importance of immunogenicity and the influence of pharmacokinetics on disease response and outcomes. Building on this foundation, other therapeutic antibodies achieved approval for inflammatory bowel disease and many more are in development for several digestive diseases. In this review, we reflect on the history of therapeutic antibodies and discuss current practice and future directions for the field.

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Individualised therapy is more cost-effective than dose intensification in patients with Crohn’s disease who lose response to anti-TNF treatment: a randomised, controlled trial

Abstract: NCT00851565.

Cited by 419 publications

References 26 publications

Cost-effectiveness of drug monitoring of anti-TNF therapy in inflammatory bowel disease and rheumatoid arthritis: a systematic review

Cost-effectiveness of drug monitoring of anti-TNF therapy in inflammatory bowel disease and rheumatoid arthritis: a systematic review

Preemptive Dose Optimization Using Therapeutic Drug Monitoring for Biologic Therapy of Crohn’s Disease: Avoiding Failure While Lowering Costs?

The Impact of Therapeutic Antibodies on the Management of Digestive Diseases: History, Current Practice, and Future Directions

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