Psoriasis
Conditions
Keywords
pediatric psoriasis, etanercept, PASS, safety, effectiveness
Brief summary
Psoriasis is a chronic, often severe, autoimmune condition that affects approximately 2% of the world's population. The epidemiology of pediatric psoriasis has not been well documented and no treatment guidelines exist for pediatric psoriasis. Etanercept is a biologic drug and has been licensed for the treatment of chronic severe plaque psoriasis in children and adolescents (6-17 years of age) who are inadequately controlled by or are intolerant to, other systemic therapies or phototherapies. Although the long-term safety and efficacy of etanercept in children with juvenile idiopathic arthritis (JIA) has been studied and the short-term safety profile of etanercept in both JIA and pediatric psoriasis appears similar, there is limited data available about the long-term effects of etanercept in pediatric psoriasis, especially with respect to malignancy. The aim of this study is to assess the safety and effectiveness of etanercept for the treatment of pediatric psoriasis in Europe. Patients aged \<=17 with plaque psoriasis diagnosed by a dermatologist will be invited to participate in the registry only after a clinical decision has been made to prescribe etanercept. The safety of the drug and how well the drug works will be evaluated during the follow-up period. The follow-up period will last 5 years and patients will be followed up every 3 months for the first 2 years and every 6 months for the next 3 years or until the end of study.
Detailed description
Non-probability sample
Interventions
DRUGEtanercept
Expected duration of 24 weeks as one course
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 17 years of age or younger * Diagnosed with plaque psoriasis by a dermatologist. * Prior to enrollment, there must be a clinical decision to initiate etanercept for the treatment of plaque psoriasis and etanercept must then be initiated. * Actively being treated with etanercept, regardless of length of treatment prior to enrollment * Willing to provide written informed consent
Exclusion criteria
* Prior therapy with any biologic agent other than etanercept * History of malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants | Baseline up to 5 years | Serious infections were defined as any infections those were life-threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalisation. Opportunistic infections of interest included protocol-specified infections due to bacteria: Salmonella bacteremia, Campylobacteriosis, Shigellosis, Mycobacterium tuberculosis, Mycobacterium avium, Mycobacterium kansasii, Syphilis, Pseudomonas aeruginosa, Acinetobacter baumannii, Listeriosis, Nocardiosis, Legionellosis, Actinomycosis, Bartonellosis; Fungal: Aspergillosis, Invasive Candida albicans, Coccidioidomycosis, Cryptococcosis, Histoplasmosis, Blastomycosis, Paracoccidioidomycosis, Sporotrichosis, Penicilliosis, Zygomycosis and Pneumocystosis; Protozoans: Cryptosporidiosis, Isosporiasis, Microsporidiosis, Acanthamoebiasis, Toxoplasmosis, Trypanosomiasis and Leishmaniasis; Viral: Cytomegalovirus, John Cunningham Virus, Disseminated or central nervous system herpes zoster, Kaposi's sarcoma and BK virus. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants | Baseline up to 28 days after last dose of study drug (up to 61 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. |
| Number of Participants Who Discontinued From Etanercept During Initial Treatment Period: Prospective Participants | Baseline up to 24 weeks | Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks. |
| Number of Participants Who Discontinued From Etanercept After Initial Treatment Period: Prospective Participants | Week 24 up to Week 216 | Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks. |
| Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants | Week 24 up to Week 216 | Participants those who completed the initial treatment period of at least 24 weeks and entered the follow up period, and during the follow up period who required subsequent treatment with etanercept or other systemic therapies were reported. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period | Week 24 up to Week 216 |
Countries
France, Germany, Greece, Hungary, Italy, Netherlands, Portugal, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years. | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Participants moved to another hospital | 4 |
| Overall Study | Participated in another clinical trial | 1 |
| Overall Study | Site closed due to non-responsiveness | 1 |
| Overall Study | Sponsor decision | 21 |
| Overall Study | Withdrawal by Subject | 4 |
| Overall Study | Withdrawal of parent/guardian consent | 1 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age, Continuous | 14.5 Years STANDARD_DEVIATION 3.3 |
| Race/Ethnicity, Customized Black | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized Other Asian | 2 Participants |
| Race/Ethnicity, Customized Unknown | 11 Participants |
| Race/Ethnicity, Customized White or Caucasian | 56 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 72 |
| other Total, other adverse events | 44 / 72 |
| serious Total, serious adverse events | 11 / 72 |
Outcome results
Primary
Number of Participants Who Discontinued From Etanercept After Initial Treatment Period: Prospective Participants
Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.
Time frame: Week 24 up to Week 216
Population: Prospective Participants: participants who started etanercept within 30 days before the enrollment date or any time after enrollment date. This outcome measure was planned to be analyzed in prospective participants only. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etanercept | Number of Participants Who Discontinued From Etanercept After Initial Treatment Period: Prospective Participants | 4 Participants |
Primary
Number of Participants Who Discontinued From Etanercept During Initial Treatment Period: Prospective Participants
Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.
Time frame: Baseline up to 24 weeks
Population: Prospective Participants: participants who started etanercept within 30 days before the enrollment date or any time after enrollment date. This outcome measure was planned to be analyzed in prospective participants only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etanercept | Number of Participants Who Discontinued From Etanercept During Initial Treatment Period: Prospective Participants | 3 Participants |
Primary
Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants
Serious infections were defined as any infections those were life-threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalisation. Opportunistic infections of interest included protocol-specified infections due to bacteria: Salmonella bacteremia, Campylobacteriosis, Shigellosis, Mycobacterium tuberculosis, Mycobacterium avium, Mycobacterium kansasii, Syphilis, Pseudomonas aeruginosa, Acinetobacter baumannii, Listeriosis, Nocardiosis, Legionellosis, Actinomycosis, Bartonellosis; Fungal: Aspergillosis, Invasive Candida albicans, Coccidioidomycosis, Cryptococcosis, Histoplasmosis, Blastomycosis, Paracoccidioidomycosis, Sporotrichosis, Penicilliosis, Zygomycosis and Pneumocystosis; Protozoans: Cryptosporidiosis, Isosporiasis, Microsporidiosis, Acanthamoebiasis, Toxoplasmosis, Trypanosomiasis and Leishmaniasis; Viral: Cytomegalovirus, John Cunningham Virus, Disseminated or central nervous system herpes zoster, Kaposi's sarcoma and BK virus.
Time frame: Baseline up to 5 years
Population: Prospective Participants: participants who started etanercept within 30 days before the enrollment date or any time after enrollment date. This outcome measure was planned to be analyzed in prospective participants only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etanercept | Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants | Serious Infections | 0 Participants |
| Etanercept | Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants | Opportunistic Infections of interest | 0 Participants |
| Etanercept | Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants | Malignancies | 0 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Time frame: Baseline up to 28 days after last dose of study drug (up to 61 months)
Population: Prospective Participants: participants who started etanercept within 30 days before the enrollment date or any time after enrollment date. This outcome measure was planned to be analyzed in prospective participants only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etanercept | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants | Treatment emergent AEs | 26 Participants |
| Etanercept | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants | Treatment emergent SAEs | 3 Participants |
Primary
Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants
Participants those who completed the initial treatment period of at least 24 weeks and entered the follow up period, and during the follow up period who required subsequent treatment with etanercept or other systemic therapies were reported.
Time frame: Week 24 up to Week 216
Population: Prospective Participants: participants who started etanercept within 30 days before the enrollment date or any time after enrollment date. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies the participants evaluable at specific rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants | Other Systemic Therapies | 26.7 percentage of participants |
| Etanercept | Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants | Etanercept therapies | 17.9 percentage of participants |
Secondary
Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period
Time frame: Week 24 up to Week 216
Population: Analysis population included all enrolled participants who were documented as having received at least 1 dose of etanercept. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period | 146.3 weeks | Standard Deviation 119.9 |