Novartis to present new interim data on the impact of Immune Thrombocytopenia (ITP) on UK patients’ physical and emotional wellbeing
Apr 16, 2018
Limited data currently exist on the impact of ITP on UK patients’ and carers’ quality of life
Interim analysis shows ITP carries a heavy physical and emotional toll
Bespoke tool (ITP Life Quality Index) in development to support patient-centric decision making in disease management
Camberley, April 16, 2018 – Novartis today announced new interim data that show a substantial physical and emotional disease burden for UK patients living with Immune Thrombocytopenia (ITP)1.
The findings, which will be presented as a poster at the British Society for Haematology (BSH) Annual Meeting, highlight UK patient data from the ITP World Impact Survey (I-WISh) showing that1:
48% of UK patients (n=25) report fatigue as the most frequent symptom they currently experience;
72% say the ITP impacts their energy levels;
68% on their normal capacity to exercise; and
60% on the undertaking of everyday tasks.
ITP is an autoimmune disorder (Immune) that causes a shortage of small cells in the blood known as platelets (Thrombocytopenia). It is characterised by a platelet count lower than 100 x 109/litre, which decreases the body’s ability to form blood clots and so the patient may be at an increased risk of bleeding2. It is a condition that affects 3,000 – 4,000 individuals in the UK at any one time3.
Currently, there is no diagnostic test for ITP – instead diagnosis is based on the exclusion of other conditions that could cause a low platelet count4. As a result, treatment decisions are often based on stabilising platelet levels and managing the risk of bleeding, and may overlook symptom burden.
UK patients also highlighted the emotional toll the disease takes on their lives, with 37% worrying about their fluctuating platelet count and 28% worrying about their condition worsening1.
“The valuable information we have received from UK patients demonstrates the severe physical and emotional toll the condition takes on their lives,” said Mervyn Morgan, CEO of the ITP Support Association. “Patients need materials and support to help them work with their clinicians and achieve better outcomes in managing their symptoms and anxieties.”
Currently, there is no tool in clinical practice to aid physicians in capturing these aspects of disease burden in adults with ITP. As a result, a discussion guide, called the ITP Life Quality Index (ILQI), is being piloted and will be presented as a poster at conference.
The guide is a 10-item patient reported outcome (PRO) measure designed to aid the discussion between patients and physicians5. Insights from clinical experts and patient interviews have been used to refine the guide and the ILQI was included as part of the I-WISh survey5.
“By working in partnership with patient groups across a range of haematological conditions, we are able to gain insights directly from those affected,” said Mari Scheiffele, General Manager of Novartis Oncology UK & Ireland. “This enables us to develop the appropriate resources to address unmet needs and support better outcomes for patients in the UK.”
Novartis has also collaborated with the ITP Support Association in the development of the ITP Pocket Log, a mobile app designed to help patients manage their ITP by keeping track of their test results and their symptoms between appointments.
Notes to editors
Additional Novartis Oncology UK activities at BSH
Poster Presentation – Real world use of Thrombopoietin-Receptor Agonists (TRA) in the management of Immune Thrombocytopenia (ITP) in the UK: Interim results from the TRAIT study
Novartis-sponsored medical symposium – CML Today and Tomorrow
Novartis-sponsored medical symposium – What Every Haematologist Should Know About CAR-T Cell Therapy
About the I-WISh survey1 The ITP World Impact Survey (I-WISh) is a cross-sectional survey of ITP patients and physicians across 14 countries. Patients have been recruited via both physicians and the patient support group (ITP Support Association, UK). Global data collection is expected to complete in April 2018.
Patients completed a 30-minute online survey providing demographic information, their experience of being diagnosed, current health state, symptoms, quality of life, and other aspects of their treatment and management. Survey materials have been designed and reviewed by a steering committee, including expert clinicians and patient advocacy leads specialising in ITP.
The mean (SD) patient age at survey completion was 52 (14.2) years and a greater proportion of the sample were female (72%). Patients had been diagnosed with ITP for 7.5 (5.7) years; 64% of the sample described their current health state as ≥ 5 using a 7-point Likert scale (7 is excellent health), whilst 8% described their health state as low (1-3 score).
About the ITP Life Quality Index (ILQI)5 The ITP Life Quality Index (ILQI) was originally developed by clinical experts and patient interviews that were conducted to provide evidence to confirm content validity, specifically regarding the relevance of concepts. A literature search was performed prior to the interviews to ensure the ILQI captured relevant concepts.
Fifteen semi-structured patient interviews were conducted with UK patients with ITP recruited via the UK ITP Support Association. Patients were asked open-ended questions to elicit spontaneous discussion of their experience, followed by questions to probe on the concepts of interest.
The interviews also involved cognitive debriefing of the ILQI using ‘think-aloud’ methods to assess understanding and relevance of items, instructions and response options. Verbatim transcripts were analysed using thematic analysis techniques.
Patients were 67% female, had a mean age of 51.3 (SD=17.4, range 23-73) and a range of education levels. Qualitative analysis identified a variety of impacts associated with ITP, including: fatigue (93%), emotional impacts (e.g. anxiety [80%]), impacts on daily living (e.g. lack of ability to partake in sport [100%]), impacts on work (e.g. absenteeism [40%]), financial impacts (e.g. working hours [40%]) and social impacts (e.g. relationship with family [60%]).
About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 121,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
In the UK, Novartis develops, manufactures and markets innovative medicines, devices and diagnostic tests which help improve patient outcomes. Based on four sites across the north and south of England, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis by manufacturing the active pharmaceutical ingredients used worldwide in many medicines. In 2016 Novartis in the UK invested almost £40million in R&D and is the largest commercial sponsor of clinical trials. For more information, please visit www.novartis.co.uk.
Cooper N, et al. Burden of disease in Immune Thrombocytopenia (ITP): The initial results for UK patients from the ITP World Impact Survey (I-WISh). The British Society of Haematology. 2018. Abstract BSH18-289.
Kistanguri G, and McCrae KR. Immune Thrombocytopenia. Hematol Oncol Clin North Am. 2013 June; 27(3): 495–520.