Documentation of Humira in Psoriasis Patients in Routine Clinical Practice

2014-08-27 03:15:35 | BioPortfolio


Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice.


Postmarketing Observational Study to Evaluate the Work Productivity, Safety and Efficacy of Humira for the Treatment of Moderate to Severe Plaque Psoriasis in Daily Clinical Practice.The primary objectives of the PMOS are to explore changes in health related care utilization data by the evaluation of:

- the number of missed working days

- the number of visits to doctor's office

- the number and duration of hospitalizations

- work ability to assess efficacy for different subgroups by

- the number of patients achieving a PASI 75 response to evaluate safety by

- the documentation and analysis of adverse events for all patients and subgroups with concomitant diseases Secondary objectives include the exploration of changes in quality of life measurements, of the influence of age, gender and duration of disease

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Moderate to Severe Plaque Psoriasis


adalimumab (Humira)


Site Reference ID/Investigator# 35037





Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:35-0400

Clinical Trials [2401 Associated Clinical Trials listed on BioPortfolio]

Comparative Clinical Trial of Efficacy and Safety of BCD-057 and Humira® in Patients With Moderate to Severe Plaque Psoriasis

CALYPSO clinical study is a phase 3 study which is carried out to establish the efficacy, safety and pharmacokinetic equivalence of BCD-055 (adalimumab, manufactured by JSC BIOCAD, Russia)...

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PubMed Articles [7239 Associated PubMed Articles listed on BioPortfolio]

Comprehensive Long-Term Safety of Adalimumab from Eighteen Clinical Trials in Adult Patients With Moderate to Severe Plaque Psoriasis.

Adalimumab (Humira ; AbbVie Inc., USA) is a fully human monoclonal antibody specific for tumour necrosis factor-α approved to treat adults with moderate-to-severe chronic plaque psoriasis.

Psoriasis Area and Severity Index (PASI) response in moderate-severe psoriatic patients switched to adalimumab: results from the OPPSA study.

Few studies have compared the efficacy of switching to adalimumab in the real-life setting in plaque psoriasis patients.

Benefit-risk of tofacitinib in patients with moderate to severe chronic plaque psoriasis: Pooled analysis across 6 clinical trials.

Although existing psoriasis treatments are effective and well tolerated in many patients, there is still a need for new effective targeted treatment options. Tofacitinib is an oral Janus kinase inhibi...

Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials.

Data on treatment outcomes in patients with psoriasis who have skin of color are limited. Brodalumab has shown efficacy in patients with moderate-to-severe plaque psoriasis.

Therapeutic equivalence of two formulations of calcipotriol-betamethasone ointment: a multi-centre, randomized, double-blind study in adult patients with chronic plaque psoriasis.

Topical agents are the first-line therapy for psoriasis and treatment of choice for mild to moderate chronic plaque psoriasis. Patients with severe psoriasis often use topical therapies at least for s...

Medical and Biotech [MESH] Definitions

A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies.

A narcotic antagonist with analgesic properties. It is used for the control of moderate to severe pain.

Endovascular procedure in which atheromatous plaque is excised by a cutting or rotating catheter. It differs from balloon and laser angioplasty procedures which enlarge vessels by dilation but frequently do not remove much plaque. If the plaque is removed by surgical excision under general anesthesia rather than by an endovascular procedure through a catheter, it is called ENDARTERECTOMY.

An opioid analgesic used similarly to MORPHINE in the control of moderate to severe pain. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1097)

For-profit enterprise with relatively few to moderate number of employees and low to moderate volume of sales.

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