PROSPER: observational study on patients with plaque psoriasis
Research type
Research Study
Full title
A prospective non-interventional study to evaluate the psychosocial impact of biologic treatment outcomes in patients with moderate-to-severe plaque psoriasis
IRAS ID
265628
Contact name
Anthony Bewley
Contact email
Sponsor organisation
Janssen-Cilag Limitd
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 3 months, 30 days
Research summary
Summary of Research
This is a retrospective and prospective, multicentre, non-interventional study. This study will be conducted in 3 NHS Trusts in the United Kingdom (UK).The study is based on both retrospective and prospective collection of data from patients’ medical records: 1) retrospective data is collected from patients' medical records 2) prospective data is collected from patient's medical records and via administration of paper questionnaires.
Patients participation will take approx. 1 year but it might be extended beyond one year if required. There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required except completing a set of questionnaires.
The population for this study is adult patients diagnosed with moderate-to-severe plaque psoriasis who received treatment with biologic therapy as part of their standard clinical care. Psoriasis is a skin condition that affects 1-3% of the population in the United Kingdom. One in five patients with psoriasis has symptoms of depression and it is estimated that there are more than 10,000 diagnoses of depression related to psoriasis every year. Therefore, improving patients’ psychosocial wellbeing, as well as their skin symptoms, is an important goal of treatment. It is expected to recruit approx. 250 patients in total.
Summary of Results
LAY SUMMARY 1.Study identification Short title: PROSPER: observational study on patients with plaque psoriasis Full title: A prospective non-interventional study to evaluate the psychosocial impact of biologic treatment outcomes in patients with moderate-to-severe plaque psoriasis IRAS project ID: 265628 Research ethics committee reference: 19/NI0179 2.Who sponsored the study and how can I contact them?
The sponsor of the study was Janssen-Cilag Ltd. This means they were responsible for setting up and running the study. They also provided the money to fund it. Janssen-Cilag Ltd can be contacted via their website: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.janssen.com%252Fuk%252Fcontact-us%252F.%2FNBTI%2FF8W5AQ%2FAQ%2Fd1fbb04b-168e-46df-aba0-f0d323788741%2F1%2FmnQV6jgjWT&data=05%7C02%7Capprovals%40hra.nhs.uk%7Ca1b3e59ff8484f49b04d08dd13858e0d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638688186516884679%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=XYDd2ZVjrKvxuoaKquL92%2BfxyKdQIlmPHOIxCKOfOcY%3D&reserved=0 Janssen-Cilag Ltd would like to thank everyone who took part.
3.General information about the research This research study started in 2020 and ended in October 2024 (when the study report was completed) and was carried out in three National Health Service (NHS) trusts in the United Kingdom (UK). This study was an ‘observational research study’, which means that we looked at what happened to patients as part of their routine care. The purpose of this study was to understand how the level of response to biologic treatment affects the mental and social wellbeing of patients with moderate-to-severe plaque psoriasis.
A biologic medicine is a type of treatment for some long-term medical conditions, including psoriasis. Treatment with biologic medicines has been shown to considerably improve the symptoms of psoriasis and can also help to improve patients’ quality of life and treatment satisfaction. However, some patients do not respond adequately to biologic treatment.
People who were aged 18 years and over, who had a confirmed diagnosis of plaque psoriasis, and were on current biologic treatment for their moderate-to-severe plaque psoriasis could take part in the study.
In this study, we wanted to compare the mental and social wellbeing of the following two groups of patients with moderate-to-severe plaque psoriasis:
• patients who had a good improvement in psoriasis symptoms (according to a set of guidelines used by doctors) in response to their biologic treatment and • patients whose biologic treatment did not work as well (biologic treatment failure) or did not help their psoriasis at all.
The study consisted of collecting data that was already in patients’ medical records and asking the patients to complete some questionnaires about mental and social wellbeing. The patients did not have to do anything different because they were taking part in the study, only complete the questionnaires, and the study itself had no impact on the medical care or the treatment received.
Researchers collected data from when patients were enrolled in the study up to 12 months. Questionnaires were completed by the patients at their regular consultation visit. To acquire demographic and medical history data, we looked back at medical records from when the patients were diagnosed with plaque psoriasis to when the patients enrolled in the study.
4.What were the results of the study?
Demographics and medical history
A total of 274 patients were included in the study, 56% were male, and the average age was 49 years. Adalimumab, received by 35% of patients, was the most common biologic prescribed to patients at the start of the study, and 75% of patients had no history of a mental health condition recorded before starting the study.
Main outcome
The impact of biologic treatment response on symptoms of depression was the main outcome in this study. The questionnaire used to assess this was called the Hospital Anxiety and Depression Scale (HADS), which has specific sections relating to depression (HADS-D) and anxiety (HADS-A) symptoms. For the main outcome, the HADS-D scores indicated that patients who failed treatment had a higher score (worse symptoms of depression) compared to patients who responded to treatment, but the difference between the groups is likely to be due to chance rather than a difference related to the treatment response.
Secondary outcomes
Scores obtained from the anxiety section of the HADS questionnaire (called HADS-A) and when the scores from the depression and anxiety sections were combined (called HADS-D&A), indicated that patients who failed treatment had higher scores (worse symptoms) compared to patients who responded to treatment. However, this difference between the groups is likely to be to chance rather than a difference related to the treatment response.
When depression symptoms were assessed with a different questionnaire (called Patient Health Questionnaire-9 [PHQ-9]), higher scores (indicating worse depressive symptoms) were seen in patients who failed treatment compared to those who responded, however, unlike the previous questionnaires, the difference between the groups was not due to chance.For questionnaires relating to daily living (called Work Productivity and Activity Impairment–Psoriasis [WPAI-PSO]), lower scores (which indicate that the psoriasis has a greater negative impact on daily living and productivity) were seen in patients who failed biologic treatment relating to general daily activities, the overall ability to work and work productivity; the difference between the groups was not due to chance.
We also found that patients with treatment failure were also less satisfied with their treatment overall (assessed with the Treatment Satisfaction Questionnaire for Medication [TSQM-9] questionnaire), had a reduced perception of how effective and convenient their treatment was compared to those who responded to treatment; these differences between the groups were not due to chance. Paired with this, the overall quality of life (assessed with the Dermatology Life Quality Index [DLQI] questionnaire) was also impacted in patients who failed treatment compared to those who responded, and the difference between the groups was not due to chance.
We also found that there was a positive association (the higher the score the lower the disease severity) between psoriasis disease severity and scores obtained from the quality of life, overall depression and anxiety, impairment while working and work productivity questionnaires and depression (when assessed by the PHQ-9 questionnaire).
Patients who had fewer previous treatments tended to have a longer duration of biologic treatment, however, the differences between patients who responded and those who failed treatment were likely to be due to chance.
5.How has this study helped patients and researchers?
•Overall, while the results of the main outcome between the groups were likely due to chance, the study demonstrates that there was a trend of worsening depression and anxiety in patients who failed biologic treatment compared to those who responded.
•It was evident that treatment failure had an impact on how the patients perceived treatment satisfaction •Patients who had failed treatment had a higher disease burden, worse quality of life and greater psychosocial burden.
•Results highlight the implications of switching biologics in patients with psoriasis which should be carefully considered by clinicians.
6.Are further studies planned?
No further studies by the sponsor on the impact of biologic treatment failure on mental and social wellbeing of patients with moderate-to-severe plaque psoriasis are planned at the current time in this region.
7.Where can I learn more about this study?
To learn more about this study, you can find more detailed information on this website:
https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.hra.nhs.uk%252Fplanning-and-improving-research%252Fapplication-summaries%252Fresearch-summaries%252Fprosper-observational-study-on-patients-with-plaque-psoriasis%252F%2FNBTI%2FF8W5AQ%2FAQ%2Fd1fbb04b-168e-46df-aba0-f0d323788741%2F2%2FUW4qrvFjno&data=05%7C02%7Capprovals%40hra.nhs.uk%7Ca1b3e59ff8484f49b04d08dd13858e0d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638688186516902307%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ASHVIbLS0YTI%2BWIW6MOSoj7yACb0cl%2F%2BZe4sU0vj%2BuY%3D&reserved=0REC name
HSC REC A
REC reference
19/NI/0179
Date of REC Opinion
17 Sep 2019
REC opinion
Further Information Favourable Opinion