APPRECIATE (Apremilast clinical treatment experience in psoriasis)
Research type
Research Study
Full title
APPRECIATE™ (APREmilast ClinIcAl Treatment Experience in psoriasis): A Multi-center, Retrospective Observational Study of Real- World Experience of Psoriasis Patients Treated with Apremilast in Clinical Dermatology Practice.
IRAS ID
202461
Contact name
Myriam Cordey Missop
Contact email
Sponsor organisation
Celgene International
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Summary of research
This is a retrospective, multi-center observational cohort study. This study will be implemented first in Germany (approximately 50 sites), the United Kingdom (approximately 20 sites) and Sweden (approximately 25 sites), followed by a selected number of countries in Europe, depending on apremilast local availability. The design of this apremilast retrospective study aims to provide clinical information regarding the treatment initiation and outcomes in psoriasis patients when prescribed apremilast in real world settings. In addition, this study is aiming at capturing physicians’ and patients’ treatment goals when initiating apremilast and whether these goals are achieved following apremilast use. This study is primarily descriptive in nature, and no a priori hypotheses are specified.
Patients must voluntarily sign an Informed Consent Form, be 18 or over, have been diagnosed with plaque psoriasis and have been treated with apremilast during the previous 5 - 7 months to participate in this study. They must not be involved in any other clinical study involving apremilast.
Summary of results
1. Study Name
Title of the Study: APPRECIATE (APREmilast ClinIcAl Treatment Experience in psoriasis): A Multi-center, Retrospective Observational Study of Real-World Experience of Psoriasis Patients Treated with Apremilast in Clinical Dermatology Practice.
Brief Title: APPRECIATE
Protocol Number: 20200066 (CC-10004-PSOR-013)
EU Trial Number Not applicable
Other Identifier NCT02740218
Date of This Summary: 15 June 2022
This summary shows the main results from one observational study. The results are only for this study. Other studies may find different results. Researchers and health authorities look at the results of many studies to decide which medicines work best and are safest for patients.
Amgen has committed to make research results available to the public. This summary has been provided as part of that commitment and should not be used for any other purpose. It should not be considered to make a claim for any product or to guide treatment decisions.
Some information in this summary may be different from the approved labelling for apremilast. Your healthcare professional should refer to the full prescribing information for proper use of apremilast.
2. Who Sponsored This Study?
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799 USA
Phone (United States): +1 805-447-1000
Amgen Inc. is the sponsor of the study and the manufacturer of apremilast, which is marketed as Otezla® (apremilast). Amgen would like to thank everyone who participated in this study and feels it is important to share the results of this study.
3. General Information About the Clinical Study
This study took place in 10 countries: Austria, Croatia, Czech Republic, Germany, Ireland, Slovenia, Spain, Sweden, Switzerland, United Kingdom.
The study began in June 2016 and ended in October 2021.
The study was completed as planned.Plaque psoriasis is a chronic inflammatory immunologic disorder which affects the skin most of all. It is characterized by defined areas of skin which look thickened, red, and scaly. Many people find these areas itchy. Plaque psoriasis occurs when the immune system mistakes normal cells in the body as unwanted invaders and attacks these cells.
Apremilast works by blocking an enzyme in the body called phosphodiesterase type 4 (PDE4) that is usually increased in medical conditions involving inflammation, such as the reddening and itching of the skin in psoriasis. Apremilast is available in the form of tablets and is taken by mouth. Apremilast has been approved for the treatment of moderate to severe chronic plaque psoriasis.
This was an observational study, which is an additional study done after a medicine has been approved by a government health authority for doctors to prescribe to patients. The purpose of the study was to describe how apremilast was prescribed and results in regular dermatology (skin) clinic practice.
4. Who Was Included in This Study?
This study included 610 participants with plaque psoriasis. 283 participants (46% or about 46 out of 100) were women and 327 participants (54% or about 54 out of 100) were men. They ranged in age from 18 to 89 years. 96 participants (16% or about 16 out of 100) were younger than 35 years old; 374 participants (61% or about 61 out of 100) were between 35 and 65 years old, and 140 participants (23% or about 23 out of 100) were older than 65 years.
This study took place at 111 sites across 10 countries in Europe.
Participants had to be over 18 years old, been diagnosed with plaque psoriasis and had started treatment with apremilast 6 months (plus or minus one month) before entering the study.
5. Which Medicines Were Studied?
Apremilast was the medicine evaluated in the APPRECIATE study. The participant’s dermatologist (skin doctor) would prescribe apremilast in the normal way, and the participant had to have been on apremilast prior to agreeing to be in the study. Both the doctor and the participant were asked to complete specific questionnaires at set points to see what their experience with apremilast was like.
6. What Were the Side Effects?
All medicines can cause side effects, or unwanted medical problems that may happen when you take a medicine. In this study, doctors reported all the medical problems participants had. Doctors believed some of the problems could have been caused by the study medicine. These possible side effects are listed below.
The table below shows how many participants had side effects.
Side Effects During the Study
610 participants
How many participants had serious side effects? 4 participants (less than 1%)
How many participants had non-serious side effects? 254 participants (42%)
How many participants died from side effects? 0 participants (0%)
How many participants stopped taking the study medicine because of side effects? 72 participants (12%)If a participant had to stay in the hospital or died because of a side effect, the doctor reported that the side effect was serious. No participant died due to a side effect.
The table below shows the serious side effects.
Serious Side Effects During the Study
Serious side effect 610 participants
Gastritis (inflammation of the stomach lining) 1 participant (less than 1%)
Migraine 1 participant (less than 1%)
Guillain-Barré Syndrome (an immune system disorder that causes nerve inflammation) 1 participant (less than 1%)
Nightmares 1 participant (less than 1%)
Night sweats 1 participant (less than 1%)
Dyspnoea (difficulty breathing) 1 participant (less than 1%)
The table below shows the non-serious side effects that occurred in at least 5% of participants (or about 5 out of 100).
Non-serious Side Effects During the Study
Non-serious side effect 610 participants
Diarrhoea (loose stools) 112 participants (18%)
Nausea (feeling sick) 86 participants (14%)
Headache 52 participants (9%)
This section only shows the most often reported side effects considered by the study doctor as related to study medicine. No single study can give a complete picture of the benefits and risks of a medicine. Information about other side effects may be available at the websites listed at the end of this summary.
7. What Were the Overall Results of the Study?
• Before starting apremilast:
o The majority of participants (80% or about 80 out of 100) had visible psoriasis plaques and 2/3 (66% or about 66 out of 100) had itching.
o The most common additional medical problem was psoriatic arthritis (inflammation in the joints in combination with psoriasis), which occurred in 24% (or about 24 out of 100) participants
o Most participants (90% or around 90 out of 100) had received another medicine for psoriasis (by mouth or by injection).
o The most common reason for stopping previous treatment was that it didn’t work (438 participants (72% or 72 out of 100)).
o A common reason for considering changing to apremilast was ease of use (medicine by mouth), 55% (or about 55 out of 100) of participants
• After 6 months of apremilast treatment:
o 425 participants (70% or about 70 out of 100) were continuing with apremilast treatment
o Doctor’s perceived effectiveness of apremilast included improvements in the majority of patients for all symptoms and for overall clearance of plaque psoriasis.
o More than half of doctors (more than 58%) agreed or strongly agreed that apremilast provided: a fast response, notably decreased plaque psoriasis, an ongoing response, clearance in specific areas, improved overall wellbeing, decreased itch, and decreased joint pain in patients with psoriatic arthritis.
o More than half of the 610 participants said that apremilast had helped their psoriasis with regard to clearance of specific areas, fast response, decreased itch, and an ongoing response. The majority of participants (more than 53%) reported that apremilast had helped to decrease regular blood tests or other monitoring, to help the participant take it as prescribed (easy to use), to reduce the number of times the participant has to go to the hospital, and to reduce itch.
More results may be available at the websites listed at the end of this summary.
8. How Has This Study Helped Participants and Researchers?
What else is important to know about these results?
These results are only for this study, which looked at a sample of 610 people with plaque psoriasis. Not all participants in the study had the same results. The results for any single participant could have been better or worse than the results for their group. Other studies may find different results. These results do not explain how a study medicine may work in a single person. This research may help future participants and families by helping doctors understand more about the study medicine being studied.
9. Are There Plans for Further Studies?
If more clinical studies are done, they may be listed on public websites, such as those below. Search for study medicine name apremilast (Otezla®) on the websites below.
10. Where Can I Find More Information About This Study?
To find out more about this study, check these websites:
www.clinicaltrials.gov. Use the study identifier NCT02740218
www.ENCePP.eu Use the study identifier EUPAS46882
If you participated in the study and have questions about the study results, the doctor or staff at your study center may be able to answer them.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
16/WM/0247
Date of REC Opinion
27 May 2016
REC opinion
Further Information Favourable Opinion