Comparison of body weight and clinical-parameter changes following the treatment of plaque psoriasis with biological therapies

ABSTRACT

Objective: This study is a retrospective analysis evaluating the presence of comorbidities, as well as the changes in body weight and clinical parameters in psoriasis patients following treatment with anti-TNF-α agents and with the anti-CD11a agent efalizumab.

Research design and methods: A total of 268 patients affected by chronic plaque psoriasis, and receiving systemic monotherapy with efalizumab, etanercept, or infliximab, were included. The follow-up period was 2, 4 and 6 months.

Main outcome measures: Clinical data including age, gender, weight, type and severity of psoriasis and age of onset were collected. Severity of psoriasis was assessed according to the Psoriasis Area and Severity Index (PASI) and body surface area (BSA).

Results: Hypertension and hyperlipidaemia were the comorbidities present with the higher frequency in our group of patients. PASI score was reduced by between 43.8 and 52% in all treatment groups. No relevant blood chemistry changes were observed following therapy, with the exception of a decrease in neutrophils and an increase in leukocyte numbers reported in the efalizumab and etanercept groups. Interestingly, after 6 months of therapy, the weight of the patients remained unvaried in those taking efalizumab (−0.05%) but was moderately increased in the etanercept (+0.72%) and in infliximab groups (+0.3%).

Conclusions: The present study shows that there were clinically significant differences in weight gain effects between efalizumab and anti-TNF-α agents in psoriatic patients. The changes in body weight gain increase did not reach statistical significance, although there is a trend towards this, and this may be due to the relatively small number of patient studied.

Keywords: :

• Biologicals
• Body weight
• Comorbidities
• Psoriasis
• Systemic treatments

Transparency

Declaration of funding

This research and the publication of this article are supported by Merck Serono SpA. All the authors take full responsibility for the contents and views expressed in the article and declare that they received no direct funding from the study sponsor.

Declaration of financial/other relationships

All the authors have disclosed that they have no significant relationships with the study sponsors, nor any other relevant financial relationships.

All peer reviewers receive honoraria from CMRO for their review work. Peer Reviewer 1 has disclosed that he/she has received research grant funding from Galderma, Astellas, Abbott, Centocor, Stiefel; that he/she is a consultant/advisor to Galderma, Abbott, Amgen, Centocor, Stiefel and that he/she is on the speakers bureau for Galderma, Abbott, Centocor, Stiefel, Astellas. Peer Reviewer 2 has disclosed that he/she has no relevant financial relationships.

Acknowledgements

The authors thank the following medical doctors of the Department of Dermatological Sciences at the University of Florence for clinical assistance: Alfaioli Barbara, Betti Silvia, Colucci Roberta, Gori Alessia, Grazzini Marta, Mokhtarzadeh Shabnam. The authors also thank Dr Sergio Di Matteo, senior analyst at S.A.V.E. (Studi Analisi Valutazioni Economiche), Milan, for statistical analysis.