Clinical trial NCT01401452: Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities
Official title: Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate to Severe Plaque Psoriasis
Keywords: Monoclonals
Moderate to severe plaque psoriasis
Psoriasis Area & Severity Index (PASI)
Adalimumab
Biological disease modifying anti-rheumatic drugs (BDMARD)
Co-morbidities
Antibodies
Disease Life Quality Index (DLQI)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Raffeiner GmbH
First posted: 2011-07-25
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital, Dermatology

Brief summary: This multicenter, post marketing observational study (PMOS) was designed to evaluate the effectiveness of adalimumab over a period of 9 months as determined by the Psoriasis Area and Severity Index (PASI) in participants with moderate to severe plaque psoriasis with distinct co-morbidities. Secondary objectives of this study were to measure changes in psychological health via the Dermatology Life Quality Index (DLQI); changes in comorbidities with respect to gender; changes in quality of life using the Short Form Health Survey (SF-36); and evaluation of Minimal Clinically Important Differences (MCID).

Detailed description: Male or female participants ages 18 years of age and older for whom the treating physician had recently prescribed adalimumab were included in this study. Adalimumab was prescribed in accordance with the terms of the local marketing authorization with regards to dose, population, and indication. There were 5 planned visits during the study: baseline (Visit 1), 1 month (Visit 2), 3 months (Visit 3), 6 months (Visit 4), and 9 months (Visit 5).

Eligibility criteria: Inclusion Criteria:

Participants for whom adalimumab therapy is indicated and has been prescribed according to the product label and who meet the following criteria:

* Participant age ≥ 18 years
* Participants with moderate to severe plaque psoriasis participants who have at last one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression (diagnosed by a medical specialist for psychology, neurology, or psychiatry)
* Adalimumab naïve participants with moderate to severe plaque psoriasis after unsatisfactory response, non tolerability, or contraindication of systemic therapies such as ciclosporin, methotrexate or PUVA ( psoralen + UVA) or after biological disease modifying anti-rheumatic drugs (bDMARDs) failure (e.g.: infliximab, etanercept or ustekinumab)
* Participants of each country must fulfill any local treatment recommendation for use of bDMARD in psoriasis in their respective country. For Austria: participants must fulfill Austrian Treatment Recommendations for use of bDMARD in psoriasis (Chest X-ray and IGRA\* interferon gamma release assay or PPD-skin test negative for tuberculosis)
* Participant is willing to give informed consent to anonymous data collection and their forwarding to AbbVie as well as to informed consent if required in different countries.
* Participant must be able and willing to self-administer adalimumab injections or have a qualified person available to administer Humira® syringe or Humira® Pen injections

Exclusion Criteria:

The following participants will not be included in this observational study:

* Participants who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SPC) and Humira Pen® SPC
* Participants participating in another study program or clinical trial
* Participants who have been treated with Humira® before

Primary outcomes:
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9
timeFrame: Baseline, Months 1, 3, 6, and 9
Secondary outcomes:
measure: Mean Dermatology Life Quality Index (DLQI) Scores
timeFrame: Baseline, Months 1, 3, 6, and 9
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9
timeFrame: Baseline, Months 1, 3, 6, and 9
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9
timeFrame: Baseline, Months 1, 3, 6, and 9
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9
timeFrame: Baseline, Months 1, 3, 6, and 9
measure: Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
timeFrame: Baseline, Months 1, 3, 6, and 9
measure: Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
timeFrame: Baseline, Months 1, 3, 6, and 9
measure: Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
timeFrame: Baseline, Months 1, 3, 6, and 9
measure: Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
timeFrame: Baseline, Months 1, 3, 6, and 9
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc
role: STUDY_DIRECTOR
References: