Real-life efficacy and safety of Ustekinumab as second- or third-line therapy in Crohn's disease: results from a large Italian cohort study.

OBJECTIVE: Ustekinumab (UST) is an anti-IL12/23 antibody for the treatment of Crohn's Disease (CD). The aim of this study was to compare the efficacy and safety of UST in a large population-based cohort of CD patients who failed previous treatment with other biologics. PATIENTS AND METHODS: 194 CD patients (108 males and 86 females, mean age 48 years (range 38-58 years) were retrospectively reviewed. 147 patients were already treated with anti-TNFα (75.8%), and 47 (24.2%) patients were already treated with anti-TNFα and vedolizumab. Concomitant treatment with steroids was present in 177 (91.2%) patients. RESULTS: At week 12, clinical remission was achieved in 146 (75.2%) patients. After a mean follow-up of 6 months, clinical remission was maintained in 135 (69.6%) patients; at that time, mucosal healing was assessed in 62 (31.9%) patients, and it was achieved in 33 (53.2) patients. Three (1.5%) patients were submitted to surgery. Steroid-free remission was achieved in 115 (59.3%) patients. Both serum C-Reactive Protein and Fecal Calprotectin (FC) levels were significantly reduced with respect to baseline levels during follow-up. A logistic regression, UST therapy as third-line therapy (after both anti-TNFα and vedolizumab), FC >200 µg/g, and HBI ≥8 were significantly associated with lack of remission. Adverse events occurred in 5 (2.6%) patients, and four of them required suspension of treatment. CONCLUSIONS: UST seemed to be really effective and safe in CD patients unresponsive to other biologic treatments, especially when used as second-line treatment.

Cancer risk among male farmers: a multi-site case-control study.

Farmers may experience exposure to several hazardous substances, and cancer risk in this occupational group is considered an important public health issue. In order to examine the association between cancer and farming among male agricultural workers, a hospital-based case-control study was conducted in five Italian rural areas. The cancer sites selected for the study were: lip, oral cavity and oropharynx, oesophagus, stomach, colon, rectum, lung, skin melanoma, skin non-melanoma, prostate, bladder, kidney, and non-Hodgkin's lymphoma. In all, 1525 newly diagnosed cases, aged 20-75 years, were ascertained in hospital records, covering the period between March 1990 and September 1992, and for 1279 of them, a detailed exposure information was collected by a standard questionnaire. Data analyses were performed comparing each cancer site to a control group, including a subset of the other cancer sites in the study. Unconditional logistic regression models were used in the statistical analyses. Increased risks of cancer associated with agricultural work were found for stomach (OR = 1.4, 95%CI:0.9-2.0), rectum (OR = 1.5, 95%CI:0.8-2.7), larynx (OR = 1.4, 95%CI:0.8-2.5), and prostate (OR = 1.4, 95%CI:1.0-2.1). The excess of prostate cancer was specifically related to application of pesticides (OR = 1.7, 95%CI:1.2-2.6).

Cancer risk among female agricultural workers: a multi-center case-control study.

BACKGROUND: Cancer risk among women engaged in farming has been poorly investigated. This group of female workers is of particular interest, however, since they may experience exposure to several potential agricultural hazards. METHODS: A hospital-based case-control study was conducted in five Italian rural areas to examine the association between cancer and farming among women. The areas selected were located in three different regions (i.e., Piedmont, Tuscany, and Emilia-Romagna). The following cancer sites were selected for the study: stomach, colon, rectum, lung, skin melanoma, skin non-melanoma, breast, cervix and corpus uteri, ovary, bladder, kidney. Cases of non-Hodgkin's lymphoma were also included. Altogether, 1,044 newly diagnosed cases aged 20-75 years were ascertained from hospital records from March 1990 to September 1992, and for 945 of them detailed information was collected by a standard questionnaire. The analyses of data were performed comparing each case series to a reference group drawn from among the other sites. Unconditional logistic regression models were used in the statistical analyses. RESULTS: Statistically significant increased risks in association with farming were estimated for skin melanoma (OR 2.7, 95% CI 1.2-5.8) and bladder cancer (OR 2.7, 95% CI 1.2-6.1). Lung cancer was also found increased but not at a statistically significant level (OR 1.7, 95% CI 0.7-4.4). An OR lower than unity was observed for postmenopausal breast cancer (OR 0.4, 95% CI 0.3-0.7). CONCLUSIONS: The present study suggests that women in farming might experience increased risk of cancers, not usually found in excess among male farmers, as well as a protective effect for postmenopausal breast cancer. The role of different patterns of exposure or gender specific responses should be considered in further studies.