DDW ePoster Library

HOW MANY PATIENTS AFFECTED BY CROHN'S DISEASE OR ULCERATIVE COLITIS NOT TREATED WITH BIOLOGIC AGENTS COULD BE ELIGIBLE FOR THESE THERAPIES IN ITALY?
DDW ePoster Library. Degli Esposti L. 05/21/21; 319705; Fr555
Luca Degli Esposti
Luca Degli Esposti
Contributions
Abstract

Number: Fr555
HOW MANY PATIENTS AFFECTED BY CROHN'S DISEASE OR ULCERATIVE COLITIS NOT TREATED WITH BIOLOGIC AGENTS COULD BE ELIGIBLE FOR THESE THERAPIES IN ITALY?

Society: AGA
Track: Inflammatory Bowel Diseases
Category: Immunology‚ Microbiology & Inflammatory Bowel Diseases

Author(s): Luca Degli Esposti1, Valentina Perrone1, Diego Sangiorgi1, Stefania Saragoni1, Elisa Giacomini1, Fernando Rizzello3, Marco Daperno4, Alessandro Armuzzi21 CliCon S.r.l., Ravenna, Italy; 2 Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; 3 Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi, Bologna, Emilia-Romagna, Italy; 4 Mauriziano Hospital, Turin, Italy

The study aims to estimate the number of patients with Crohn's Disease (CD) or Ulcerative Colitis (UC) presenting criteria of eligibility for biologic therapies in Italian clinical practice setting.
An observational analysis was performed based on administrative databases of a sample of Local Health Units distributed across Italy and covering a population of 6.8 million beneficiaries. All adult patients with CD or UC diagnosis from 2000 to end of data availability were included. Diagnoses were identified by ICD-9-CM code (555 for CD, 556 for UC) and/or active exemption code (009.555 for CD, 009.556 for UC). The following criteria were applied to evaluate the eligibility for biologics (Table 1): Criterion A: switch to intestinal anti-inflammatory agents or conventional drugs (no biologic) after 2 weeks therapy with prednisone or prednisolone up to 0.75mg/kg/day. Criterion B: treatment with systemic corticosteroids or budesonide for ≥3 months without relapse or relapse within 3 months after stopping systemic corticosteroids. Criterion C: intolerance or contraindication to conventional therapies defined as early effects, effects associated with prolonged use (usually >12 weeks) and effects during withdrawal. Criterion D: presence of relapse identified by increased corticosteroid dose (≥1 prescription above initial dose within 3 months) or hospitalization with CD or UC as main diagnosis. Criterion E (CD patients only): highly active CD disease and poor prognosis defined as CD patients starting treatment with systemic corticosteroids or with concomitant perianal disease at CD diagnosis.
From preliminary results, 26,781 patients with a diagnosis of CD or UC were identified. Prevalence was 135.0/100,000 people for CD and 258.7/100,000 people for UC diagnoses. Of diagnosed patients identified, 3,125 (11.7%) patients were already in treatment with a biologic agent. Among patients untreated or treated with intestinal anti-inflammatory agents or conventional drugs indicated for CD or UC (N= 23,656), 7,651 (corresponding to 28.6% of study population) met at least one of the criteria for eligibility to biologics. Specifically, 46.0% of eligible patients presented at least the criterion B (steroid-dependence) and 63.6% had at least the criterion D (relapse)
Our preliminary findings showed a tendency of undertreatment in the cohort analyzed. Over one-fourth (28.6%) of CD or UC patients presented one or more criteria of eligibility for biologic therapies, mainly related to an extensive use of steroids or presence of relapse and were not actually receiving such treatments.

Number: Fr555
HOW MANY PATIENTS AFFECTED BY CROHN'S DISEASE OR ULCERATIVE COLITIS NOT TREATED WITH BIOLOGIC AGENTS COULD BE ELIGIBLE FOR THESE THERAPIES IN ITALY?

Society: AGA
Track: Inflammatory Bowel Diseases
Category: Immunology‚ Microbiology & Inflammatory Bowel Diseases

Author(s): Luca Degli Esposti1, Valentina Perrone1, Diego Sangiorgi1, Stefania Saragoni1, Elisa Giacomini1, Fernando Rizzello3, Marco Daperno4, Alessandro Armuzzi21 CliCon S.r.l., Ravenna, Italy; 2 Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; 3 Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi, Bologna, Emilia-Romagna, Italy; 4 Mauriziano Hospital, Turin, Italy

The study aims to estimate the number of patients with Crohn's Disease (CD) or Ulcerative Colitis (UC) presenting criteria of eligibility for biologic therapies in Italian clinical practice setting.
An observational analysis was performed based on administrative databases of a sample of Local Health Units distributed across Italy and covering a population of 6.8 million beneficiaries. All adult patients with CD or UC diagnosis from 2000 to end of data availability were included. Diagnoses were identified by ICD-9-CM code (555 for CD, 556 for UC) and/or active exemption code (009.555 for CD, 009.556 for UC). The following criteria were applied to evaluate the eligibility for biologics (Table 1): Criterion A: switch to intestinal anti-inflammatory agents or conventional drugs (no biologic) after 2 weeks therapy with prednisone or prednisolone up to 0.75mg/kg/day. Criterion B: treatment with systemic corticosteroids or budesonide for ≥3 months without relapse or relapse within 3 months after stopping systemic corticosteroids. Criterion C: intolerance or contraindication to conventional therapies defined as early effects, effects associated with prolonged use (usually >12 weeks) and effects during withdrawal. Criterion D: presence of relapse identified by increased corticosteroid dose (≥1 prescription above initial dose within 3 months) or hospitalization with CD or UC as main diagnosis. Criterion E (CD patients only): highly active CD disease and poor prognosis defined as CD patients starting treatment with systemic corticosteroids or with concomitant perianal disease at CD diagnosis.
From preliminary results, 26,781 patients with a diagnosis of CD or UC were identified. Prevalence was 135.0/100,000 people for CD and 258.7/100,000 people for UC diagnoses. Of diagnosed patients identified, 3,125 (11.7%) patients were already in treatment with a biologic agent. Among patients untreated or treated with intestinal anti-inflammatory agents or conventional drugs indicated for CD or UC (N= 23,656), 7,651 (corresponding to 28.6% of study population) met at least one of the criteria for eligibility to biologics. Specifically, 46.0% of eligible patients presented at least the criterion B (steroid-dependence) and 63.6% had at least the criterion D (relapse)
Our preliminary findings showed a tendency of undertreatment in the cohort analyzed. Over one-fourth (28.6%) of CD or UC patients presented one or more criteria of eligibility for biologic therapies, mainly related to an extensive use of steroids or presence of relapse and were not actually receiving such treatments.

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