1. Risk of Serious Infection in Patients with Psoriasis Receiving Biologics

Results

• Patients receiving Humira, Enbrel and Stelara did not have a significantly higher risk of serious infections as compared to patients receiving conventional systemic drugs.
• There was no difference in the risk of serious infections between Humira, Enbrel and Stelara.

2. Drug Survival of Second-Line Biologic Therapies in Patients with Psoriasis

Results

• 77% of patients who were switched to a second biologic continued on the new treatment for at least 12 months. This dropped to 58% of patients continuing treatment in year 3.
• Stelara had the highest drug survival rate over 3 years of treatment.
• Second-line discontinuation due to adverse events (AEs) was more common among those who discontinued first-line treatment due to AEs.

Purpose
Drug survival, defined by the length of time a patient stays on a drug, is an indicator of how effective a drug continues to be over time and/or whether a drug is stopped because of a side effect etc. If the first biologic used to treat the patient (first-line therapy) is not effective or the patient experiences side effects their dermatologist may start them on a different biologic. This is known as a second-line biologic therapy. This study was carried to find out how successful second-line biologics are for patients.

3. Intentional and Unintentional Medication Non-Adherence in Psoriasis

Results

• 22.4% of patients using self-administered systemic therapies are classified as non-adherent.
• Patients using an oral conventional systemic agent were more likely to be non-adherent compared to those using Enbrel or Humira.
• The risk factors associated with non-adherence were strong medication beliefs i.e. the patient having strong medication concerns and poor habit strength; a weaker routine of taking their medication.

Purpose
Medication non-adherence can be intentional, where patients make a deliberate decision not to follow the prescribed medication schedule, or unintentional such as forgetting to take the medication. It is important to understand why patients do not adhere to drugs in order to identify the risk factors of non-adherence. This study was carried out to find out if such risk factors can be targeted in order to improve treatment effectiveness.

4. Generating EQ-5D-3L Utility Scores from the DLQI

Purpose
The Dermatology Life Quality Index (DLQI) is the most widely used questionnaire to assess quality of life related to skin disease in psoriasis studies. However it is not relevant to other diseases and therefore when comparisons are required the information collected is not transferable. The EQ-5D-3L questionnaire is used to assess quality of life across all diseases and in healthy individuals. The National Institute for Health and Care Excellence (NICE) includes EQ-5D-3L as part of the standardised assessment when making a decision on whether a drug should be made available to patients on the NHS. This study was carried out to determine if information collected using the DLQI can be used by researchers to predict a EQ-5D-3L score.

Results

• The results of this study demonstrated that it was possible to reasonably predict EQ-5D-3L utility scores from the DLQI data. A user-friendly freely accessible tool has been produced to enable analysts to use this system.

Conclusion
Although it remains preferable to use scores derived directly from the EQ-5D-3L, this system can be used to generate utility estimates in future evaluations of treatment for patients with psoriasis.

5. Comparison of Drug Discontinuation, Effectiveness and Safety Between Clinical Trial Eligible and Ineligible Patients in BADBIR

Purpose
Patients with psoriasis enrolled in clinical trials of biologics may not be similar to those treated in dermatology clinic. This could mean that results achieved in clinical trials e.g. safety and efficacy may be different when drugs are used in the “real world”. There is evidence that patients who would not meet the entry criteria for such trials (ineligible) have a greater risk of serious adverse events (SAEs), but the effect on drug discontinuation and effectiveness are unknown.

Results

• Psoriasis patients receiving biologic therapy who were identified as ineligible for clinical trials were twice as likely to experience a serious adverse event (SAE) when compared with eligible patients in the first 12 months of treatment.
• These same ineligible patients had significantly lower levels of improvement in their psoriasis when compared with eligible patients in the first 12 months of treatment (Humira, Enbrel and Stelara).
• There were no differences in overall discontinuation rates between eligible and ineligible categories for any of the biologics investigated.

Conclusion
Psoriasis patients enrolled in clinical trials on biologics are not entirely representative of real-world patients. Dermatologists should be mindful of these differences when counselling patients on biologic treatment.

6. Cumulative Exposure to Biologics and Risk of Cancer in Psoriasis Patients: Psonet studies from Israel, Italy, Spain, United Kingdom and Republic of Ireland

Purpose
In theory, there may be an increased risk of cancer following long‐term exposure to biologic therapies in patients with psoriasis. The aim of this study was to assess the relationship between total length of exposure to biologic therapy and risk of cancer.

Results

• Psonet comprises independent drug safety registries that collaborate to investigate the long-term safety and effectiveness of biologic and systemic therapies in patients with moderate-to-severe psoriasis.
• In this study the total length of exposure to biologics was found not to be associated with the risk of developing cancers, even after considering the effect of age, gender, location, previous exposure to methotrexate, ciclosporin and phototherapy, duration of psoriasis, and other medical conditions.

Conclusion
Total length of exposure to biologic therapies in psoriasis patients treated in real‐world clinical practice does not appear to be linked to a higher risk of cancer after several years of use.