Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis

Conditions

Arthritis, Psoriatic

Keywords

postmarketing surveillance, Enbrel, psoriatic arthritis

Brief summary

The aim of this study is to evaluate if the data obtained in controlled clinical trials are confirmed when Enbrel is used in usual clinical practice in Belgium according to local reimbursement criteria.

Related papers

No related papers found yet.

Interventions

OTHERQuestionnaire

This is a non-interventional study

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Active erosive psoriatic arthritis of poly-articular type or active erosive or with joint space narrowing psoriatic arthritis of oligo-articular type * At least 18 years old * Have fulfilled reimbursement criteria for Enbrel in psoriatic arthritis of poly-articular type or oligo-articular type * Physician decides to prescribe Enbrel or patient is already on Enbrel * Give written informed consent at time of inclusion to study

Exclusion criteria

NA

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1	Baseline up to Year 1	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2	Year 1 up to Year 2	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3	Year 2 up to Year 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4	Year 3 up to Year 4	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5	Year 4 up to Year 5	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6	Year 5 up to Year 6	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Secondary

Measure	Time frame	Description
Percentage of Participants With at Least 1 Adverse Event (AE) Per Year	Baseline up to Year 6	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)	Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78	HAQ is a 20 item questionnaire to measure functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 items grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Total score range 0-60, higher score indicating greater functional limitations.
Incidence of Adverse Events and Serious Adverse Events Per Participant-Year	Baseline up to Month 6, 12, 18, 30, 42, 54, 66	Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100. Incidence of AEs and SAEs were broken down by each follow-up time period.
Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment	Baseline up to Month 78	—
Number of Joints With Active Arthritis	Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78	Numbers of joints with active arthritis were defined as joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness.
Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation	Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78	Quality of life for oligo-articular type arthritis was assessed on a 11-point Numerical Rating Scale (NRS) ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per participant was evaluated.
Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation	Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78	Quality of life for oligo-articular type arthritis was assessed on a 11-point NRS ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per physician was evaluated.

Countries

Belgium

Participant flow

Participants by arm

Arm	Count
Etanercept Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.	303
Total	303

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	32
Overall Study	Death	2
Overall Study	Lost to Follow-up	32
Overall Study	Non-responder	52
Overall Study	Reason not related to Etanercept	29

Baseline characteristics

Characteristic	Etanercept
Age Continuous	48.29 Years STANDARD_DEVIATION 10.83
Sex: Female, Male Female	137 Participants
Sex: Female, Male Male	166 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	179 / 301
serious Total, serious adverse events	65 / 301

Outcome results

Primary

Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Time frame: Baseline up to Year 1

Population: Safety set included all the participants who signed informed consent form (ICF) and had at least one dose of study medication and had follow-up data.

Arm	Measure	Value (NUMBER)
Etanercept	Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1	7.97 Percentage of participants

Primary

Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Time frame: Year 1 up to Year 2