Patient-reported real-world experience of risankizumab onbody injector

• Research type

  Research Study

• Full title

  Patient-reported real-world experience of risankizumab on-body injector (OBI) for the treatment of Crohn’s disease in the UK: a before-and-after survey of participants among patients that transition from maintenance treatment (360 mg applied by 4x90 mg PFS) within the Early Access to Medicine Scheme / Pre-Approval Access Schemes to Free-Of-Charge use of OBI

• IRAS ID

  326609

• Contact name

  Rachel Horsfall

• Contact email

  rachel.horsfall@abbvie.com

• Sponsor organisation

  AbbVie Ltd

• Duration of Study in the UK

  0 years, 11 months, 29 days

• Research summary

  Summary of Research
  Risankizumab is a medicine that has undergone regulatory approval for the treatment of Crohn's disease and other inflammatory diseases in the United Kingdom, European Union and elsewhere. In the UK, risankizumab has been available to patients with Crohn’s disease who are participating in Pre-Approval Access and Early Access to Medicines Schemes since 2019 and 2022, respectively.

  At present, risankizumab is administered by self-injection using multiple pre-filled syringes. However, these pre-filled syringes will be replaced by an on-body injector (OBI), a medical device, that automatically delivers risankizumab in a single injection at the push of a button.

  In 2023, up to 153 patients receiving risankizumab as part of these schemes will switch administration method from pre-filled syringes to the OBI. This presents the first opportunity to characterise patient satisfaction with OBI for the treatment of Crohn’s disease in the real-world.

  Summary of Results
  Title: Patient-reported experience of risankizumab on-body injector for the treatment of Crohn’s disease in the UK: a before-and-after survey

  Why was the research needed?
  Crohn’s disease (CD) is a chronic condition that causes inflammation in the digestive system, leading to symptoms such as abdominal pain, diarrhoea, fever, and weight loss. Although there is no cure, treatments can help manage symptoms. These include medications to reduce inflammation, prevent it from returning, and in some cases, surgery.
  Risankizumab, a biologic medicine, is used for maintenance therapy in people with moderate to severe CD. Traditionally, risankizumab is administered through multiple injections using pre-filled syringes, but a new method, using an on-body injector (OBI) delivers the dose in a single injection. However, there is currently no data available on how satisfied patients are with this treatment method in practice.
  This study aimed to assess how patients felt about self-injecting risankizumab using an OBI while receiving maintenance treatment for CD in the UK. The study, sponsored by AbbVie, was conducted in the secondary and tertiary care centres where doctors are experienced in prescribing risankizumab for the maintenance treatment of CD.

  What were the results of the study?
  Fifty adult patients with CD completed a questionnaire before and after their first OBI injection. They rated their experiences on a scale where higher scores indicate better experiences. Patients’ demographics, clinical conditions, and initial treatment details were collected from medical records.
  Of these patients, 58% were female, and the average age in the study was 39.4 years. Before the first OBI injection, 28% had severe CD, and 76% had undergone bowel surgery related to CD.
  Eighty-one percent of the patients were positively satisfied with OBI, compared to 54% for pre-filled syringes. Satisfaction was higher among those using the OBI at home (90%) compared to those using in a hospital (65%). Patients felt more confident with self-injecting OBI (score 7.5 out of 10) compared to pre-filled syringes (score 6.7). They found OBI easy to use (score 8), experienced minimal pain and side effects (score 8.9), and felt less embarrassed (score 10).

  How did this study help patients and researchers?
  When patients are highly satisfied, confident, and experience minimal pain or side effects from their treatment, they are more likely to adhere to their treatment plan. Better adherence can lead to improved health outcomes, particularly for patients receiving treatment at home.

  Thank You
  The study sponsor, AbbVie, would like to thank all the study participant centres and their patients for helping to deliver this research.
  

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  23/NW/0195

• Date of REC Opinion

  28 Jul 2023

• REC opinion

  Further Information Favourable Opinion