Available Data on Pediatric Exposure Response a Clinician s Perspective
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1 Available Data on Pediatric Exposure Response a Clinician s Perspective Marla Dubinsky, MD Professor of Pediatrics and Medicine Chief Pediatric GI and Nutrition Co-Director Susan and Leonard Feinstein IBD Clinical Center Icahn School of Medicine, Mount Sinai New York
2 Disclosures Consultant: Janssen, Abbvie, Takeda, Prometheus Labs, Celgene, Pfizer, Genentech, UCB, Salix, Arena, Eli Lilly Research Support: Janssen, Abbvie, Pfizer, Prometheus Labs Co-Founder: Mi Test Health Co founder: Cornerstones Health
3 Thiopurine metabolite levels: our first understanding of exposure vs response Frequency of Response 100% 80% 60% 40% 20% 0% n= % Dubinsky MC et al. Gastroenterol2000;118: n= n= TGN QUARTILES 78% P< Odds Ratio 5.0 for treatment response when 6-TGN > 235 n=
4 Association of 6-thioguanine nucleotide levels and IBD activity: a meta-analysis Osterman MT. Gastroenterology 2006;130:
5 Anti-TNF concentrations correlate with outcome: Cohort studies and post-hoc analysis Disease Drug Concentration Clinical outcome Notes CD (Maser CGH 2006) IFX Detectable Clinical remission, CRP, Trough assessed after 1 year (range after 6-37 Endoscopic remission infusion) CD (Cornillie GUT 2014) IFX > 3.5 Sustained response Post hoc analysis of ACCENT I CD (Bortlik JCC 2013) IFX > 3 Sustained response Week 14 or 24 trough CD (Lamblin JCC 2012) IFX > 5.6 Reduced CRP CD (Drobne Gastro 2011) IFX Undetectable Loss of response UC (Arias JCC 2012) IFX > 7.19 Sustained response UC (Seow GUT 2010) IFX Detectable Higher rates of remission, Undetectable serum IFX associated with Endoscopic improvement colectomy Failed to respond to increase CD/UC (Yanai AJG 2011) IFX > 3.8 in IFX or change to another anti-tnf Population was patients with LOR CD/UC (Roblin CHG Higher trough concentrations associated with ADA > 4.9 Mucosal healing 2014) clinical remission and mucosal healing Failed to respond to increase CD/UC (Yanai AJG 2011) ADA > 4.5 in ADA or change to another Population was patients with LOR anti-tnf CD/UC (Roblin AJG 2014) ADA < 4.9 ug/ml Prospective trial with ADA demonstrating Clinical response to ADA benefit of dose optimization for low trough dose intensification concentration UC (Velayos CGH 2013) ADA > 4.58 ug/ml Week 12 clinical response Week 2-4 concentration predicts week 12 response Higher quartile CD (Colombel CGH 2014) CTP (mean value for Endoscopic and clinical response and remission highest quartile: 30.1 ug/ml)
6 Prospective therapeutic drug monitoring to optimise infliximab maintenance therapy in IBD Retrospective cohort of patients in clinical remission, single physician practice Infliximab dose optimisation to trough concentrations 5 10 µg/ml (n=48) No infliximab dose optimisation (n=78) Evaluated probability of remaining on infliximab, for up to 5 years Probability on infliximab Optimised Not optimised p= Probability on infliximab IFX trough 5 IFX trough <5 Not tested p< p= Weeks on infliximab Weeks on infliximab Dose optimisation increases probability of remaining on infliximab up to 5 years Vaughn BP et al. Inflamm Bowel Dis 2014
7 Loss of Response Over Time to Biologics Cohort of 309 CD patients who responded to induction with IFX Annual risk of loss of response to IFX was 12% per patient-year Chaparro M et al. J Clin Gastro 2011
8 IFX Durability in Pediatric IBD Percentage of patients on IFX p=0.41 Vahabnezhad E et al IBD 2014 Time to IFX discontinuation (months)
9 Week 14 Infliximab Levels and Outcomes Singh and Dubinsky et al Inflamm Bowel Disease 2014;20:
10 Clinical Utility of Week 14 levels Predicting Durability Singh and Dubinsky et al Inflamm Bowel Disease 2014;20:
11 Factors Affecting the Pharmacokinetics of Monoclonal Antibodies Presence of ADAs Concomitant use of IS High baseline TNF-α Low albumin High baseline CRP Body size Gender Impact on Pharmacokinetics Decreases serum mabs Threefold-increased clearance Worse clinical outcomes Reduces formation Increases serum mabs Decreases mab clearance Better clinical outcomes May decrease mabs by increasing clearance Increased clearance Worse clinical outcomes Increased clearance High BMI may increase clearance Males have higher clearance ADA, antidrug antibody; mab, monoclonal antibody Ordas I et al. Clin Pharmacol Ther
12 Infliximab durability Decreased with Monotherapy IFX and Reactive TDM 1.0 Mono ptdm Combo SOC Survival on Infliximab (%) p =.004 Mono SOC Time (weeks) Number at risk Mono ptdm Mono SOC Combo SOC Lega S et al Inflamm Bowel Dis epub ahead of print
13 Antibodies to Infliximab increased with monotherapy IFX and reactive TDM 1.0 Combo SOC ATI-free survival (%) Mono ptdm P <.001 Mono SOC 0.0 Number at risk Time (weeks) Mono ptdm Mono SOC Combo SOC Lega S et al Inflamm Bowel Dis epub ahead of print
14 THE FUTURE: THE MAGIC OF INDUCTION PK DASHBOARDS AND EARLY OPTIMIZED MONOTHERAPY
15 Figure 1. Example of Precision IFX idose Dashboard Forecast (Projections Research) Bayesian Dashboard System
16 STUDY POPULATION Patient Population 114 ENROLLED & Rec d 2 Doses 69 IFX 5 MG/KG Week 0 61 IFX 5 MG/KG Week 2 45 IFX 10 MG/KG Weeks 0 58 INFUSION #3 46 IFX 10 MG/KG Weeks 2 Exclusions: Protocol Deviations n = 8 Early Termination due to ATI n = 2, INF #3 Not Yet Completed n = 1 Early Termination due to Non-response n = 1, Protocol Deviation n = 4, INF#4 Not Yet Completed n = 3 50 INFUSION #4
17 Results: idose-driven Dosing (N=50) 50 IFX 5 MG/KG Weeks 0 and 2 INFUSION #3 (dosing forecasted using INF #1 and 2 data) IFX target 17 58% On-Label (week 6) (N=29) 42% Dose Intensified Dose and/or frequency (N=21) INFUSION #4 (dosing forecasted using INF #1, 2, 3 data) IFX target 10 22% On-Label (week 14) (N= 11) 78% Dose Intensified Dose and/or frequency (N=39) 86% interval shortening (n = 18) 10% dose increase + interval shortening (n = 2) 5% dose escalation (n = 1) 79% dose increase + interval shortening (n = 31) 21% internal shortening (n = 8)
18 Results: Median Intervals Dosing Intervals for Infusions #3 and #4, N=50 Interval Between First and Last Infusion ON LABEL DOSE INTENSIFICATION Days From Last Dose Days From First Dose Days From Last Dose Days From First Dose INF # 3 INF # 4
19 Pediatric vs Adult IBD IFX Dosing 100% 90% 80% 83% 70% 60% 50% 40% 52% 50% Adults Pediatrics 30% 20% 10% 0% 0% 3 4 Infusion Number
20 BP updated 22AUG2018 Infusion 2 Characteristics Grouped by SOC vs DI at Infusion #3 INFUSION #2 Characteristics On-Label at Inf#3 (n=29) Dose Intensified at Inf#3 (n=21) Median IQR Median IQR Albumin (n=48) C-Reactive protein (n=47) Weight Dose (mg/kg) IFX Concentration (n=49)
21 BP updated 22AUG2018 Infusion 3 Characteristics Grouped by SOC vs DI at Infusion #4 INFUSION #3 Characteristics On-Label at Inf#3 (n=11) Dose Intensified at Inf#3 (n=39) Median IQR Median IQR Albumin C-Reactive protein Weight Dose (mg/kg) IFX Concentration (n=49) # of Subjects w/ ATI (n=3) 0 3
22 Exposure Response: A Clinician s Perspective Therapeutic Drug Monitoring not a foreign concept to pediatricians Early post induction drug concentrations improve durability Proactive Induction optimization is superior to post induction Children need optimization earlier than Adults Exposure not dose is the target Age of 18 means you can vote but arbitrary for drug approval as more about pk similarity PK dashboards provide a more robust dosing strategy for infliximab
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