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Optimising Treat to Target in Kingdom of Saudi Arabia

Optimising Treat to Target in Kingdom of Saudi Arabia. Briefing Slides for Round Table. Monitoring IBD patients. Treat to Target. Subrata Ghosh, MD, FRCPC, FRCP, FRCPE, AGAF, FCAHS Director, Institute of Translational Medicine Professor of Translational Medicine University of Birmingham, UK.

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Optimising Treat to Target in Kingdom of Saudi Arabia

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  1. Optimising Treat to Target in Kingdom of Saudi Arabia Briefing Slides for Round Table

  2. Monitoring IBD patients Treat to Target Subrata Ghosh, MD, FRCPC, FRCP, FRCPE, AGAF, FCAHS Director, Institute of Translational Medicine Professor of Translational MedicineUniversity of Birmingham, UK

  3. Disclosures

  4. Walk a mile in our patients’ shoes… Where andhow can weOPTIMISEmanagementto improveoutcomes? 1 Target achieved? Life before illness Adherence challenges • Steroids are not intended for long-term use • Potential failure of conventional therapies 2 Onset of symptoms 6 Quality of life 4 Biologicinitiation 5 3 Steroid use Diagnosis and management plan Change in quality of life in a theoretical IBD patient

  5. Lémann Index measures bowel damage and the potential impact of treatment MODULE 1 • Quantitative tool to assess cumulative structural bowel damage in CD1 • Entire GI tract is evaluated for damage and an overall score calculated • WHERE in the GI tract? • WHAT severity of damage (surgery, stricturing lesions, penetrating lesions)? • EXTENT of surgery and lesions? • Used to assess damage progression,2–3 and to evaluate treatment strategy over time4, 5 • Potential endpoint for disease-modification trials Male with a small bowel resection (58 cm, 3 x 20 cm segments), stricturing and prestenotic dilatation (grade 3, 2 segments), small bowel fistula (grade 3), and anal stricturing (grade 3) What istreatingto target? Upper tract = 0 Why istreatingto targetimportant? Colon or rectum = 0 Proposedtreat-to-targetapproachin IBD Small bowel = 2.2 Anus = 3.5 Summary Overall Lémann Index score = 23.25 1. Pariente B, et al. Inflamm Bowel Dis 2011;17:1415–22; 2. Gilletta C, et al. . J Crohns Colitis 2015; 9(Suppl1):S57; 3. Bhagya Rau B, et al. J Clin Gastroenterol 2016;50:476–82; 4. Fiorino G, et al. J Crohns Colitis 2015;9:633–9; 5. Fiorino G et al.J Crohns Colitis 2016;10:495-500

  6. Lémann Index score significantly increased with disease durationin a prospective, cross-sectional, observational study in patients with CD MODULE 1 19.0 What istreatingto target? MedianLémann index score 138 patients with CD Age (median): 34 years CDAI (median): 187 CDAI <150 (n): 50 14.3 Why istreatingto targetimportant? Median Lémann Index score increased with duration of disease P<0.001 6.3 Proposedtreat-to-targetapproachin IBD 0 0 15 20 10 Summary <2 years(n=45) ≥2 to <10 years(n=46) ≥10years(n=47) Disease duration in years Pariente B, et al. Gastroenterology 2015;148:52–63

  7. Treatment goals for inflammatory bowel disease continue to evolve MODULE 1 Future goals are moving toward changing the course of the disease1–4 What istreatingto target? Symptomimprovement5 Clinical remission5 Steroid-free remission5,6 Mucosal healing6–9 Deep remission4,10 Reduction of hospitalization, surgeries11 Why istreatingto targetimportant? Evolving endpoints Proposedtreat-to-targetapproachin IBD • Goals of therapy in IBD have historically been based on symptomatic response with good control of symptoms and improved quality of life1 • We now have objective measures of inflammation that may allow tighter control of the inflammatory process1 • There is still a need for long-term observational studies to determine whether complete clinical and inflammatory remission is required in all patients1 Summary 1. Lichtenstein GR, et al. Am J Gastroenterol. 2018;113(4):481–517; 2. Regueiro MD, et al. Am J Gastroenterol. 2016;3(suppl):8–16; 3. Panaccione R, et al. Inflamm Bowel Dis 2013;19:1645–53; 4. Colombel JF, et al. Dig Dis. 2012;30(suppl 3):107–111; 5. Colombel JF, et al. Gastroenterology 2007;132:52–65; 6. Colombel JF, et al. N Engl J Med 2010;362:1383–95; 7. Baert FJ, et al. Gastroenterology 2010;138:463–68; 8. Sandborn WJ, et al. J Crohns Colitis 2010;4:S36; P060; 9. Louis E, et al. Gastroenterology. 2012;142(1):63–70.e5; 10. Colombel JF, et al. J Crohns Colitis 2010;4:S10; P16; 11. Feagan BG, et al. Gastroenterology. 2008;135(5):1493–1499.

  8. Treating to target in IBD: proposed stepwise algorithm for clinical practice MODULE 1 What istreatingto target? Active IBD Target Sustainedtarget TREAT-TO-TARGET STRATEGY Why istreatingto targetimportant? TARGET ACHIEVED Continue monitoringto sustainthe target 4Monitor regularly 1Assess risk factors 2Set appropriate target 5Optimise therapy as necessary 3Treatin a timely manner Proposedtreat-to-targetapproachin IBD TARGET NOTACHIEVED Summary Adapted from: Bouguen G, et al. Clin Gastroenterol Hepatol 2015;13:1042–50; Smolen JS, et al. Ann Rheum Dis 2015;0:1–13

  9. Target recommendations for Crohn’s disease:treat beyond symptoms* MODULE 1 What istreatingto target? & Clinical/PRO remission Endoscopic remission Why istreatingto targetimportant? Resolution of abdominal pain and normalisation of bowel habit • Assess at least every 3 months during active disease Resolution of ulceration Assess 6–9 monthsduring the active phase Proposedtreat-to-targetapproachin IBD Biomarkers: CRP and FCP are adjunctive measures of inflammationfor monitoring CD (not targets) Failure of CRP or FCP normalisation should prompt further endoscopic evaluation, irrespective of symptoms Summary *Resolution of symptoms alone is not a sufficient target; objective evidence of inflammation of the bowel is necessary when making clinical decisions STRIDE, Selecting Therapeutic Targets in IBD; CRP, C-reactive protein; FCP: faecal calprotectin; PRO, patient-reported outcome Peyrin-Biroulet L, et al. Am J Gastroenterol 2015;110:1324–38

  10. Target recommendations for ulcerative colitis:treat beyond symptoms MODULE 1 What istreatingto target? & Clinical/PRO remission Endoscopic remission Why istreatingto targetimportant? Resolution of rectal bleeding and normalisation of bowel habit • Assess at least every 3 months during active disease Resolution of friability and ulceration (Mayo 0–1) Assess 3–6 months after initiating therapy Proposedtreat-to-targetapproachin IBD Biomarkers: CRP and FCP are adjunctive measures of inflammationfor monitoring UC (not targets) Failure of CRP or FCP normalisation should prompt further endoscopic evaluation, irrespective of symptoms Summary STRIDE, Selecting Therapeutic Targets in IBD; CRP, C-reactive protein; FCP: faecal calprotectin; PRO, patient-reported outcome Peyrin-Biroulet L, et al. Am J Gastroenterol 2015;110:1324–38

  11. Treat-to-target approach has been explored in IBD clinical studies MODULE 1 • In algorithm-driven, prospective treatment studies, the treat-to-target approach was associated with a: What istreatingto target? Lower rate of hospitalisation, surgery and complications in patients with established Crohn’s disease1 • Combined immunosuppression algorithmic approach, treating to the target of clinical remission, compared with a conventional approach Why istreatingto targetimportant? Lower rate of endoscopic recurrence in postoperative Crohn’s disease2 • Colonoscopy and treatment step-up for endoscopic recurrence, compared with risk-stratified drug therapy alone Proposedtreat-to-targetapproachin IBD Higher rate of mucosal healing with absence of deep ulcers in early Crohn’s disease3 • Treatment optimisation driven by biomarker levels (CRP and FCP) and clinical symptoms, compared with clinical symptoms alone Summary CRP, C-reactive protein; FCP: faecal calprotectin 1. Khanna R, et al. Lancet 2015;386;1825–34; 2. De Cruz P, et al. Lancet 2015:11;385:1406–17; 3. Colombel JF, et al. Lancet 2018;390:2779–89

  12. CALM: Evidence for a treat-to-target approach in IBD vs MODULE 2 • Open-label, multicentre study in patients with early* moderate-to-severe CD • Patients (n=244) randomised to: • Tight control (treat-to-target approach)– Treatment optimisation based on biomarkers(CRP, FCP), steroid use and clinical symptoms (CDAI) • Clinical management – Treatment optimisation based on steroid use and clinical symptoms (CDAI) • Monitored every 12 weeks • Primary endpoint was mucosal healing (CDEIS <4) with absence of deep ulcers at week 48 Clinical management Tight control Clinicalevidencefrom CALM Quality-of-lifedata Cost-effectivenessdata Evidencefrom otherstudies CALM is the first study to show that timely optimisation of therapybased on clinical symptoms combined with biomarkers in patients with early* CDresults in improved clinical and endoscopic outcomesthan optimisation based on symptoms alone Summary *Early CD defined in CALM as CD diagnosis confirmed by endoscopy not >6 years before baseline CDEIS, Crohn's Disease Endoscopic Index of Severity; CRP, C-reactive protein; FCP, faecal calprotectin Colombel JF, et al. Lancet 2018;390:2779–89

  13. CALM: Inclusion and exclusion criteria Inclusion criteria1 MODULE 2 CDAI ≥220 and ≤450 (no CS at baseline)CDAI ≥200 and ≤450 (≤20 mg CS for ≥7 days before baseline)CDAI >150 and ≤450 (>20 mg CS for ≥7 days before baseline) Moderate to severe CD Clinicalevidencefrom CALM Quality-of-lifedata CDEIS >6 and sum of CDEIS sub-scores>6 in ≥1 segment with ulcers Active endoscopic disease CDEIS2 • Presence of deep/superficial ulceration • Surface involvement by disease or ulceration in ileum, right colon, transverse, left and sigmoid colon, and rectum Cost-effectivenessdata CRP ≥5 mg/L and/orFCP ≥250 µg/g at screening Evidencefrom otherstudies Exclusion criteria1 Previous or current immunomodulator or biologic use >2 previous courses CS or >3-month duration CS use at screening Summary CDAI, Crohn’s disease activity index; CDEIS, Crohn’s disease endoscopic index of severity; CRP, C-reactive protein; CS, corticosteroids; FCP, faecal calprotectin.1. Colombel JF, et al. Lancet 2018;390:2779–89; 2. Mary JY, et al. Gut. 1989;30:983–9.

  14. CALM study design: Steroid burst and randomisation MODULE 2 Tight control(n=122) Clinicalevidencefrom CALM Prednisone 40 mg/day burst and taper Quality-of-lifedata Clinical management(n=122) Laboratory assessments Cost-effectivenessdata Week: -9 -4 -1 0 12 24 36 48 Early randomisation in patients with: CDAI >220 AND • Steroid >4 weeks and needed tapering,including 2 weeks of prednisone ≥40 mg or an equivalent daily dosage • Steroid intolerance / contraindication • Investigator discretion Evidencefrom otherstudies Summary CDAI, Crohn’s disease activity index Colombel JF, et al. Lancet 2018;390:2779–89

  15. CALM study design: Treatment initiated at Week 0 MODULE 2 Treatment with ADA if meeting ≥1 of below: • CDAI ≥150 • CRP ≥5 mg/L • FCP ≥250 µg/g • Prednisone use Tight control(n=122) Clinicalevidencefrom CALM Prednisone 40 mg/day burst and taper Quality-of-lifedata Clinical management(n=122) Treatment with ADA if meeting ≥1 of below: • CDAI ↓ <70 vs baseline • CDAI >200 Laboratory assessments Cost-effectivenessdata Week: -9 -4 -1 0 12 24 36 48 ADA 40 mg EW + AZA Evidencefrom otherstudies ADA 40 mg EW ADA 160/80 mg, then 40 mg EOW† Summary No treatment †Patients received ADA 160 mg at Week 0 and 80 mg at Week 2 if they were escalated from no treatment ADA, adalimumab; AZA, azathioprine; CDAI, Crohn’s disease activity index; CRP, C-reactive protein; EOW, every other week; EW, every week; FCP, faecal calprotectin. Colombel JF, et al. Lancet 2018;390:2779–89

  16. CALM study design: Treatment optimisation at Weeks 12, 24 and 36 MODULE 2 Treatment escalation if meeting ≥1 of below: • CDAI ≥150 • CRP ≥5 mg/L • FCP ≥250 µg/g • Prednisone use 1 week prior Tight control(n=122) Clinicalevidencefrom CALM Prednisone 40 mg/day burst and taper Quality-of-lifedata Clinical management(n=122) Treatment escalation if meeting ≥1 of below: • CDAI ↓ <100 vs baseline • CDAI ≥200 • Prednisone use 1 week prior Laboratory assessments Cost-effectivenessdata Week: -9 -4 -1 0 12 24 36 48 ADA 40 mg EW + AZA †† Evidencefrom otherstudies ADA 40 mg EW †† ADA 160/80 mg, then 40 mg EOW† Summary No treatment †Patients received ADA 160 mg at Week 0 and 80 mg at Week 2 if they were escalated from no treatment; ††Patients who were de-escalated from ADA 40 mg EW + AZA, they continued receiving AZA after de-escalation. ADA, adalimumab; AZA, azathioprine; CDAI, Crohn’s disease activity index; CRP, C-reactive protein; EOW, every other week; EW, every week; FCP, faecal calprotectin. Colombel JF, et al. Lancet 2018;390:2779–89

  17. CALM study design: Rescued patients followed tight control algorithm MODULE 2 Treatment escalation if meeting ≥1 of below: • CDAI ≥150 • CRP ≥5 mg/L • FCP ≥250 µg/g • Prednisone use 1 week prior Tight control(n=122) Clinicalevidencefrom CALM Prednisone 40 mg/day burst and taper Quality-of-lifedata Clinical management(n=122) Treatment escalation if meeting ≥1 of below: • CDAI ↓ <100 vs baseline • CDAI ≥200 • Prednisone use 1 week prior Cost-effectivenessdata Week: -9 -4 -1 0 12 24 36 48 Rescue CDAI >300 for 2 consecutive visits 7 days apart or per investigator discretion Evidencefrom otherstudies Summary CDAI, Crohn’s disease activity index; CRP, C-reactive protein; FCP, faecal calprotectin Colombel JF, et al. Lancet 2018;390:2779–89

  18. CALM: Primary and key secondary endpoints MODULE 2 Primary endpoint (at 48 weeks) Clinicalevidencefrom CALM • CDEIS <4 (mucosal healing) and no deep ulcerations Quality-of-lifedata Key secondary endpoints (all at 48 weeks) • Deep remission (CDAI <150, CDEIS <4, and no deep ulcers, absence of draining fistula,discontinuation of steroids ≥ 8 weeks) • Biologic remission (FCP <250 g/g, CRP <5mg/L, and CDEIS <4) • Mucosal healing (CDEIS <4) • Overall mucosal healing and mucosal healing in all segments (overall CDEIS <4 and CDEIS <4 in each segment) • Complete endoscopic remission (CDEIS = 0) • Endoscopic response (CDEIS decrease >5 points) • Steroid-free remission (CDAI <150 and discontinuation of steroid use ≥8 weeks) over time Cost-effectivenessdata Evidencefrom otherstudies Summary CDAI, Crohn’s disease activity index; CDEIS, Crohn’s disease endoscopic index of severity; CRP, C-reactive protein; FCP, faecal calprotectin.Colombel JF, et al. Lancet 2018;390:2779–89

  19. CALM: Primary endpoint at Week 48 Tight control resulted in significantly more patients achievingmucosal healing (CDEIS <4) with no deep ulcerations than clinical management MODULE 2 Clinicalevidencefrom CALM p=0.010 Quality-of-lifedata Patients (%) Cost-effectivenessdata Evidencefrom otherstudies 37/122 56/122 Summary Endoscopic scoring is based on site read. Cochran-Mantel-Haenszel test stratified by smoking status (yes/no) and weight (<70/≥70 kg) at screening. Non-responder imputation (NRI) analysis. Colombel JF, et al. Lancet 2018;390(10114):2779–2789.

  20. CALM: Secondary endpoints at Week 48 Tight control resulted in significantly higher rates of deep remission,biologic remission and mucosal healing than clinical management MODULE 2 Clinicalevidencefrom CALM Quality-of-lifedata Patients (%) Cost-effectivenessdata p=0.006 p=0.728 p=0.010 p=0.229 p=0.067 p=0.014 Evidencefrom otherstudies Deep remission CDAI <150,CDEIS <4 andno deep ulcers,no draining fistula,discontinuation ofcorticosteroidsfor ≥8 weeks Biologicremission CRP <5 mg/L,FCP <250 µg/g,CDEIS <4 Mucosalhealing CDEIS <4 Overallmucosal healingplusmucosal healingin all segments Overall CDEIS <4,CDEIS <4 in all segments Completeendoscopicremission CDEIS=0 Endoscopicresponse CDEIS decrease>5 points Summary Colombel JF, et al. Lancet 2018;390(10114):2779–2789.

  21. CALM: Steroid-free remission over Weeks 11–48 Tight control resulted in significantly more patients achievingsteroid-free remission at each study visit versus clinical management MODULE 2 Clinicalevidencefrom CALM Quality-of-lifedata Cost-effectivenessdata p=0.009 p=0.003 p=0.007 p<0.001 Patients (%) Evidencefrom otherstudies Summary Steroid-free remission, CDAI <150 and discontinuation of steroid use for at least 8 weeks. Cochran-Mantel-Haenszel test stratified by smoking status (yes / no) and weight (<70 / ≥70 kg) at screening. NRI analysis. Colombel JF, et al. Lancet 2018;390(10114):2779–2789.

  22. CALM: Safety findings MODULE 2 Clinicalevidencefrom CALM Quality-of-lifedata Cost-effectivenessdata Evidencefrom otherstudies Summary Safety profile was similar between treatment groupsand consistent with the known safety profile of adalimumab in CD Colombel JF, et al. Gastroenterology 2017;152(Supplement 1):S155.

  23. CALM: time to CD flare 1.0 Proportion of patientswithout CD flare* 0.8 Log-rank p=0.010 0.6 HR=0.4 (95% CI: 0.2, 0.8) p=0.012 0.4 Clinical management 0.2 Tight control 0 0 10 20 30 40 50 Weeks after randomisation Patients at risk: CM: TC: 122 122 97 107 94 105 85 101 78 94 75 86 • Early significant separation in the time to CD flare*between the CM and TC groups • *Increase in CDAI ≥70 points from one week prior to randomisation OR early randomisation and CDAI >220. CD: Crohn’s disease; CM: clinical management; TC: tight control. Colombel JF, et al. Gastroenterology 2017;152(Suppl 1):S155; Colombel JF, et al. United European Gastroenterol J 2017:Abstract 1057

  24. CALM: rates of CD-related hospitalisations after randomisation p=0.021 29 events 14 events n=122PY=103.6 n=122PY=106.3 • Significantly fewer events of CD-related hospitalisations were observed in the TC group than in the CM group • E: events; PY: patient-years. Colombel JF, et al. Gastroenterology 2017;152(Suppl 1):S155; Colombel JF, et al. United European Gastroenterol J 2017:Abstract 1057.

  25. CALM study design: Quality of life assessed at Weeks 12, 24, 36 and 48 MODULE 2 • Quality-of-life measures: • Inflammatory Bowel Disease Questionnaire (IBDQ; range 32–224) • SF-36 Physical Component Summary score (SF-36 PCS; range 0–100) • SF-36 Mental Component Summary score (SF-36 MCS; range 0–100) • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F; range 0–52) • Patient Health Questionnaire-9 (PHQ-9; range 0–27) • Work Productivity and Activity Impairment (WPAI) questionnaire (range 0–100) Tight control(n=122) Quality of lifedata Prednisone 40 mg/day burst and taper Clinical management(n=122) Quality-of-life assessments Cost-effectivenessdata Clinicalevidencefrom CALM Week: -9 -4 -1 0 12 24 36 48 Evidencefrom otherstudies Summary Pannacione R. ECCO 2018; Oral DOP071

  26. CALM: Quality of life improvements over Weeks 12–48 MODULE 2 Tight control improved quality of life measuresbeyondthe improvements seen with clinical management1 Quality of lifedata • Numerically higher improvement across all measures • Improvement in most measures from Week 12 • Impact on cost-effectiveness (e.g. in the UK2) Cost-effectivenessdata Clinicalevidencefrom CALM QoL measures give an indication of a patient’s physical and mental health, and motivation and ability to take part in life’s activities e.g. IBDQ includes questions about fatigue, feeling frustrated, energy levels, feeling worried or depressed, feeling embarrassed, and satisfaction with life3 Evidencefrom otherstudies Summary a. A higher value of PHQ-9 represents a higher level of symptoms of depression; a higher value of WPAI represents a higher percentage of work productivity affected b. Answered by patients who were employed (approximately 50% of the population) * p<0.05 tight control vs clinical management, using mixed models accounting for longitudinal measures, baseline smoking status, baseline weight, and corresponding baseline outcome values 1. Pannacione R. ECCO 2018; Oral DOP071; 2. Panaccione R, et al. United European Gastroenterol J 2017;5(5S):OP017; 3. Guyatt G, et al. Gastroenterology 1989;96:804–10

  27. How is cost-effectiveness calculated? MODULE 2 • Cost-effectiveness analysis compares the costs and health effect of an intervention to assess the extent to which it provides value for money • Cost-effectiveness ratio (CER) = Cost of treatment A • Success of treatment A Cost-effectivenessdata Direct costs (medical and patient expenses) and indirect costs (impact on productivity and intangibles) Quality-adjusted life-year (QALY) is a measure of quantity and quality of life(1 QALY = 1 year of perfect life) Quality-of-lifedata Clinicalevidencefrom CALM If comparing two interventions, A and B: Incremental CER (ICER) = Difference in cost of treatment A and B Difference in success of treatment A and B …A is dominant over B if it has both a lower cost and a greater health effect Evidencefrom otherstudies Summary Cohen DJ, Reynolds MR. J Am CollCardiol2008;52(25):2119–26; Zilberberg MD, Shorr AF. ClinMicrobiol Infect 2010;16:1707–12

  28. CALM cost-effectiveness calculation in the UK Direct medical costs1 MODULE 2 Hospitalisation costs Model designed to evaluate cost-effectiveness of tight control versus clinical management using data from CALM and costs in the UK1–3 • Average number of CD-related hospitalisations from CALM • Hospital cost data from UK-based research, from NHS perspective Cost-effectivenessdata Adalimumab dose costs • Number of adalimumab doses estimated from CALM • UK list prices used for ADA costs Quality-of-lifedata Clinicalevidencefrom CALM Other direct medical costs • Including outpatient visits, laboratory tests and endoscopic procedures Quality-adjusted life-years(QALYs) Evidencefrom otherstudies Incremental cost-effectiveness ratio (ICER):Δ Costs / Δ QALYsbetween tight control and clinical management Summary CDAI: Crohn’s disease activity index; EQ-5D, EuroQol- 5 Dimension (an instrument to measure quality of life) 1. Panaccione R, et al. United European Gastroenterol J 2017;5(5S):OP017; 2. https://www.nice.org.uk/guidance/ta187/chapter/3-the-technologies (accessed March 2018); 3. Buxton, et al. Value in Health 2007;10(3):214–20.

  29. CALM cost-effectiveness outcomes in the UK MODULE 2 Compared with clinical management,tight control had: Cost-effectivenessdata • Higher remission rate • Fewer CD-related hospitalisations Quality-of-lifedata Clinicalevidencefrom CALM • More adalimumab doses Evidencefrom otherstudies Summary * Predicted time in remission is the model’s estimate of the proportion of time spent with CDAI under 150 over 48 weeks, estimated using CALM data Panaccione R, et al. United European Gastroenterol J 2017;5(5S):OP017.

  30. CALM: Cost-effectiveness of tight control versus clinical management in the UK MODULE 2 Total direct medical costs Quality-adjusted life-years Cost-effectivenessdata 0.684 £13,296 £12,627 0.652 Costs (£000) QALYs Δ costs = £669 (95% CI: £2,529, –£1,994) Δ QALY = 0.032 (95% CI: 0.042, 0.021) Quality-of-lifedata Clinicalevidencefrom CALM ICER: Δ costs / Δ QALYs = Evidencefrom otherstudies £20,913 / QALY(95% CI: £94,116 to –£61,457 [TC dominant]) Summary Panaccione R, et al. United European Gastroenterol J 2017;5(5S):OP017.

  31. Regular monitoring involves baseline and ongoing assessments MODULE 3 • EXAMPLE MONITORING SCHEDULE: Baseline(e.g. diagnosis, flare) Ongoing monitoring Monitordiseaseregularly Tailor yourtreat-to-targetapproach 4–6 weeks 3 months 6 months 12 months 0 Refer anddiagnosepatientsquickly Engagepatients FCP CRP TAUS TAUS FCP and/or CRP and/or TAUS FCP and/or CRP and/or TAUS FCP and/or CRP and/or TAUS Assess riskof diseaseprogression Endoscopy Endoscopy (UC) Endoscopy (CD) Treat in a timely manner Resolution offriability andulceration (Mayo 0–1)3–6 months after initiating therapy and at 3-month intervals during the active phase Resolution ofulceration 6–9 month intervals during the active phase Timeframe for assessing endoscopic targets1 Summary CRP, C-reactive protein; FCP, faecal calprotectin; TAUS, Transabdominal ultrasound 1. Peyrin-Biroulet L, et al. Am J Gastroenterol2015;110:1324–38

  32. Interpreting faecal calprotectin test results: FCP 250 μg/g as a guide to next steps MODULE 3 Guide to interpreting FCP test results CALM assessment of FCP levels in patients achieving endoscopic outcomes at Week 481 <250 μg/g ≥250 μg/g FCP 100–250 µg/g Monitordiseaseregularly Inflammation possible Tailor yourtreat-to-targetapproach 100 Further tests* may be required to confirm presence / absence of inflammation2 Refer anddiagnosepatientsquickly Engagepatients p<0.001 p<0.001 77.3 80 74.2 Assess riskof diseaseprogression *Further tests may include another FCP test, TAUS or other imaging modalities 60 Patients (%) FCP ≥250 µg/g 40 35.6 Active inflammation likely Treat in a timely manner 20 13.6 Optimise therapy to addressongoing inflammation2 Summary 75/97 21/59 72/97 8/59 0 Endoscopic response (CDEIS decrease >5 from baseline) CDEIS <4 andno deep ulcers (Primary endpoint) CDEIS, Crohn's disease endoscopic index of severity; FCP, faecal calprotectin 1. Reinisch W, et al. Presented at ECCO 2018:OP015; 2. Adapted from Bressler B, et al. Can J Gastroenterol Hepatol2015;29:369–72

  33. Suggested monitoring to support a treat-to-target approach MODULE 3 • Measure and record all baseline levels to track disease activity over time (endoscopy, FCP, CRP, ) • Regularly monitor disease activity using non-invasive objective markers (CRP, FCP, ) • Measure and record precise, standardised descriptions of endoscopic lesions (type, location, depth, extent) • Adopt appropriate monitoring for different patient situations Do Don’t Monitordiseaseregularly Tailor yourtreat-to-targetapproach • Rely on symptoms to monitor disease activity alone • Assume symptoms alone relate to active disease • Take short-cuts: be thorough in understanding disease activity in each patient Refer anddiagnosepatientsquickly Engagepatients Assess riskof diseaseprogression Treat in a timely manner Summary CRP, C-reactive protein; FCP, faecal calprotectin; TAUS, Transabdominal ultrasound

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