Metabolic abnormalities associated with initiation of systemic treatment for psoriasis: evidence from the Italian Psocare Registry


  • Funding support
    The Psocare project was supported by the Italian Drug Agency, Agenzia Italiana del Farmaco (AIFA), via the AIFA resolution dated June 13, 2005. These analyses were also supported by the Ministero della Salute and the Ministero dell’Istruzione, Università e Ricerca Scientifica (Programmi di Ricerca Scientifica di Rilevante Interesse Nazionale).

  • Financial disclosure
    Dr. Naldi is a member of the Global Steering Committee of the Psolar Registry supported by Centocor and serves as a consultant for Janssen-Cilag. Dr. Gisondi served as a consultant for Pfizer. Dr. Chimenti served and/or is serving as a consultant for Abbott, Merck, Pfizer and Janssen-Cilag. Dr. Girolomoni served and/or is serving as a consultant for Abbott, Merck and Pfizer. Dr. Giannetti served as a consultant for Abbott, Merck and Pfizer. Dr. Picardo served as a consultant for Abbott and Pfizer.

L. Naldi.


Objective  To evaluate variations in laboratory parameters and diagnoses of selected clinical conditions up to 16 weeks after starting a new systemic psoriasis treatment for Psocare Registry enrollees.

Design  Prospective cohort study.

Setting  Italian public referral centres for psoriasis treatment.

Patients  First-time recipients (= 10,539) of continuous systemic psoriasis treatment for at least 16 weeks.

Main outcome measure  Mean variations in (weeks 8 and 16) and proportions of patients reaching a clinically meaningful increase in serum levels (week 16) of total and low-density lipoprotein cholesterol, triglycerides, aspartate amino transferase, alanine amino transferase and creatinine, as well as week-16 cumulative incidences of new diagnoses of diabetes mellitus and arterial hypertension.

Results  Mean cholesterol and triglyceride levels significantly increased in patients treated with acitretin or cyclosporine. Mean triglyceride levels also increased in efalizumab- and etanercept-treated patients. Mean transaminase values increased in methotrexate-treated patients, and mean aspartate amino transferase levels increased in infliximab-treated patients. The average serum creatinine value increased in cyclosporine-treated patients. Acitretin and cyclosporine were associated with risk of hypercholesterolaemia (odds ratios 1.51 and 1.34) and acitretin with risk of hypertriglyceridaemia (odds ratio 1.43). Methotrexate and infliximab were associated with risk of more than doubling the upper normal aspartate amino transferase (odds ratios 2.06 and 1.87) and alanine amino transferase (odds ratios 2.38 and 1.74) values. The relative risk of developing arterial hypertension and diabetes was increased for patients receiving cyclosporine (odds ratios 3.31 and 2.88).

Conclusion  Systemic treatments for psoriasis resulted in heterogeneous effects on the parameters analysed.