Impact of Body Mass Index and Obesity on Clinical Response to Systemic Treatment for Psoriasis (Evidence from the Psocare Project)

Study identification

• EU PAS number:
  EUPAS1620
• Study ID:
  16746
• Official title and acronym:
  Impact of Body Mass Index and Obesity on Clinical Response to Systemic Treatment for Psoriasis (Evidence from the Psocare Project)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Objective: Our aim was to assess the role of the body mass index (BMI) in the clinical response to systemic treatment for psoriasis. Methods: A nationwide cohort study of patients receiving a new systemic treatment for plaque psoriasis at reference centres in Italy was conducted. Information was gathered through a web-based electronic form. Patients being maintained on the same medication and with data available at 8 and 16 weeks by March 31, 2007, were eligible. The outcome was a reduction in the Psoriasis Area Severity Index (PASI) of at least 75% at follow-up compared to baseline (PASI-75). Results: Out of 8,072 patients enrolled, 2,368 were eligible and analysable at 8 weeks and 2,042 at 16 weeks. PASI-75 was achieved by 819 patients (34.5%) at 8 weeks and1,034 (50.6%) at 16 weeks. The proportion steadily decreased with increased values of BMI. Compared to normal weight (BMI = 20–24) the adjusted odds ratio for achieving PASI-75 in obese patients was 0.73 (95% CI = 0.58–0.93) at 8 weeks and 0.62 (95% CI = 0.49–0.79) at 16 weeks. The impact of the BMI did not show remarkable variations according to the drug prescribed at entry. Conclusion: The BMI affects the early clinical response to systemic treatment for psoriasis.
• Study status:
  Finalised

Research institutions and networks

Institutions

Centro Studi GISED

Italy

Multiple centres: 147 centres are involved in the study
Psocare, Italy

Networks

Psocare

Study timelines

Date when funding contract was signed

Planned: 01/06/2005

Actual: 24/04/2012

Study start date

Planned: 01/09/2005

Actual: 02/10/2012

Date of final study report

Planned: 31/03/2007

Actual: 05/11/2013

Sources of funding

Other

More details on funding

Agenzia Italiana del Farmaco

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable