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WHAT IS iSTART?1

 

iSTART (i Support Therapy-Access to Rapid Treatment) is a Ferring Pharmaceuticals initiative consisting of a global expert panel to improve patient-centred management for mild to moderate UC. Under iSTART, patients on optimised first-line therapy will be provided with training on how to identify a flare and provided with a prescription to self-start a time limited, second-line treatment (Cortiment®) for use when their first-line 5-ASA treatment is no longer maintaining remission.
Only select patients should be chosen by physicians for this initiative. These are those patients who:

  • Are at high risk of relapse
  • Have limited access to healthcare services
  • Have an active interest in their disease
  • Have a low risk of clostridium difficile infection

 

WHAT ARE THE AIMS OF iSTART?1

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iSTART aims to provide patients with the ability to:

  • Self-assess symptoms
  • Increase dosing of first-line therapy
  • Self-start a short course of second-line treatment

It is designed to fit within the framework supplied by published treatment guidelines.

For an initiative like iSTART to work, patients require reliable methods to self-assess their condition. Appropriate indices (as they are simple and validated) include:

  • PRO2 which uses stool frequency and rectal bleeding as indicators
  • PRUCSI which uses the 6-point Mayo score and general well-being
  • mHI-UC which incorporates patient-reported measures derived from the UCDAI

PRO2 = Patient reported outcome; PRUCSI = Patient-reported UC activity index; mHI-UC = mobile health index for UC.

 

CONSENSUS METHODS1

Supporting evidence gathered from 3 literature reviews on UC epidemiology; 5-ASA treatment, second-line therapy and validated tools for self-led patient assessment

Draft consensus statements developed from evidence-based reviews and current mild to moderate UC treatment guidelines

International panel of gastroenterology experts assembled

Panel voted whether they “strongly agree,” “agree” or “disagree/uncertain” for each

Statement was passed if ≥75% of panel agreed/strongly agreed with a statement

If consensus not reached, statements revised via group discussion

Agreed consensus used to produce a series of recommendations voted on using the same methodology

iSTART RECOMMENDATIONS1

1

Primary focus of treatment in UC is the rapid induction of remission followed by maintenance of this remission in the long-term

2

Treatment of flare as soon as possible to get mild to moderate UC patients back into remission:

  1. 5-ASA optimisation (high dose/topical)
  2.  Rapid access to second-line therapies

3

Treatment for mild to moderate UC should begin with optimised 5-ASA therapy: high dose oral and/or at least 1 g/day topical, in line with current treatment guidelines

4

Oral budesonide MMX® is a preferred corticosteroid for a mild to moderate flare and should be initiated as soon as possible by patients not responding to optimised 5-ASA

5

Patients with mild to moderate UC should have active involvement in their disease management and therapy to enable rapid treatment

6

Patient reported outcomes can be used by patients:

• For flare identification

• To monitor disease activity

• To initiate treatment

• As a management tool for suitable patients

7

PRO2 and PRUCSI are appropriate patient-reported indices for self-assessment:

• Simple, validated and strong discriminatory power for flare

• Score increase of >1 over 3-5 days could identify a flare

8

Programs such as iSTART could provide improved treatment of flares in UC patients

 

 

PRO2 = Patient reported outcome; PRUCSI = Patient-reported UC activity index.

  • Danese S, et al. Intestinal Research. 2018;16(4):522–528.

Job Code: UK-COR-2200001 - Date of preparation: January 2022

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