BACKGROUND: The cumulative exposition to biologics is increasing with prolonged treatment with a certain biologic or consecutive biological treatment. However, long-term safety data are limited available. OBJECTIVES: The aim of this study was to prospectively evaluate the 5-year safety of biological treatment for @entity1569 in daily practice. METHODS: A cohort of 173 @entity1569 @entity1 on biologics was prospectively followed for 5 years. All adverse events reported were documented and analysed. Primary endpoint was the percentage of @entity1 reporting at least one serious adverse event. The rate of @entity5 , serious @entity281 and serious cardiovascular events was compared with the general population incidence rate. The nature and rate of dermatological adverse events was compared with a group of prospectively followed @entity309 @entity1 on @entity310 blocking therapy. RESULTS: Between February 2005 and April 2010, 173 @entity1 were enrolled in the registry and went through a total number of 263 treatment episodes. The total number of @entity1 -years of follow-up in the registry was 409. The number of @entity1 -years was the highest for etanercept. Forty-nine @entity1 (28%) reported 88 serious adverse events. Only one serious adverse event was certainly causally related to the biologic and 21 events (24% of SAEs) were considered possibly related. The incidence of @entity5 , serious @entity281 and serious cardiovascular events was comparable with the population incidence rate, except for @entity272 . The incidence of @entity272 was significantly higher than the general population incidence rate. The nature and rate of dermatological adverse events differed from the @entity309 cohort. CONCLUSIONS: In this cohort, the safety of biological therapies for @entity1569 was favourable with a low incidence of therapy-related serious adverse events.

Safety of treatment with biologics for XXXX in daily practice: 5-year data.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity1569 :: ('MESH:D011565', 'Disease') :: ['psoriasis'] @entity5 :: ('MESH:D009369', 'Disease') :: ['malignancies'] @entity310 :: ('7124', 'Gene') :: ['TNF-a'] @entity281 :: ('MESH:D007239', 'Disease') :: ['infections'] @entity272 :: ('MESH:D012871', 'Disease') :: ['skin malignancies'] @entity309 :: ('MESH:D001172', 'Disease') :: ['rheumatoid arthritis']
@entity1569 :: (MESH:D011565,Disease) :: ['psoriasis']
