TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis

Production of Antibodies Against Tnf-alfa Blockers in Patients With Psoriasis

TNF alfa blockers are widely used for treatment of severe psoriasis. These biologics are well-tolerated with few side effects.

Unfortunately not all patients respond adequately to treatment with tnf alfa blockers. Some do not respond at all while others respond initially but gradually lose effect despite increased dose and more frequent administration.

The cause of treatment failure is largely unknown and it may be production of tnf-alfa neutralizing antibodies. This has been demonstrated in patients with rheumatoid arthritis and inflammatory bowel disease who lost response after treatment with tnf-alfa blockers.

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Drug: subjects will receive either infliximab, adalimumab or etanercept

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lone Skov, MD, PhD; Phone Number: +4539773204; Email: lone.skov.02@regionh.dk
• Study Contact Backup: Name: Peter Jensen, MD; Phone Number: +4539777538; Email: peter.jensen@regionh.dk

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Recruiting
    • Copenhagen University Hospital Gentofte, Department of Skin and Allergies
    • Contact: Lone Skov, MD, PhD; Phone Number: +4539773204; Email: lone.skov.02@regionh.dk
    • Contact: Peter Jensen, MD; Phone Number: +4539777538; Email: peter.jensen@regionh.dk
    • Principal Investigator: Lone Skov, MD, PhD
    • Sub-Investigator: Peter Jensen, MD
    • Sub-Investigator: Claus Zachariae, MD, PhD
• Sweden
  • Stockholm, Sweden, 17177
    • Recruiting
    • Karolinska Institute, Department of Medicine
    • Contact: Mona Ståhle, MD, PhD; Email: mona.stahle@ki.dk
    • Principal Investigator: Mona Ståhle, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female
• Age above 18
• Psoriasis
• Indication for treatment with tnf alfa blocking drug
• Written informed consent obtained

Exclusion Criteria:

• Severe psychiatric disorder
• No indication for treatment with tnf-alfa blocking drug
• Pregnancy
• Breastfeeding
• No written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: tnf-alfa treatment (infliximab, adalimumab, or etanercept); This arm includes all the patients of the study. They are patients who are start treatment with a tnf-alfa blocking drug

Drug: subjects will receive either infliximab, adalimumab or etanercept; The subjects receive treatment with a tnf-alfa blocking according to the official guidelines for the particular drug. The study subjects will receive treatment with one drug only -; infliximab or; adalimumab or; etanercept The consulting dermatologist decides which drug to use according to official guidelines; Other Names: adalimumab; infliximab; etanercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in concentration of tnf-alfa antibodies in serum	Measurement (ELISA) of concentration of tnf-alfa neutralizing antibodies	3, 6, and 12 months after start of tnf-alfa blocking agent

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in severity of psoriasis, PASI	severity of psoriasis assessed by PASI	3, 6, and 12 months after start of tnf-alfa blocking agent
Presence of psoriatic arthritis	Does the patient have psoriasis arthritis	3, 6, and 12 months after start of tnf-alfa blocking agent
change in dermatology life quality index (DLQI)	psoriasis severity assessed by the dermatology life quality index (DLQI)	3, 6, and 12 months after start of tnf-alfa blocking agent
height (cm)	subject´s height in centimeters	3 months
change in weight (kg)	subjects weight in kilograms	3, 6, and 12 months after start of tnf-alfa blocking agent

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of change in concentrations of other biomarkers of interest in psoriasis	Collection of 3 ml of serum which are kept at -80 degrees celcius for later analysis of future biomarkers of interest	3, 6, and 12 months after start of tnf-alfa blocking agent

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborators: Pfizer; The Michaelsen Foundation
• Investigators: Study Director: Lone Skov, MD, PhD, Copenhagen University Hospital Gentofte, Department of Skin and Allergies; Principal Investigator: Mona Ståhle, MD, PhD, Karolinska Institute, Department of Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: July 30, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimate): August 6, 2012

Study Record Updates

• Last Update Posted (Estimate): August 6, 2012
• Last Update Submitted That Met QC Criteria: August 3, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: psoriasis; treatment failure; tnf-alfa
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Dermatologic Agents; Etanercept; Adalimumab; Infliximab
• Other Study ID Numbers: H-2-2012-001 (Registry Identifier: Ethics committee of the Capital Region of Denmark)