Vedolizumab may be an effective option for the treatment of postoperative recurrence of Crohn's disease.

BACKGROUND: The role of Vedolizumab (VDZ) as therapeutic option for the postoperative recurrence of Crohn's disease (CD) following ileocolonic resection is unknown. AIMS: To assess the effectiveness of VDZ in this setting. METHODS: All consecutive CD patients with a baseline colonoscopy at 6-12 months from the ileocolonic resection showing postoperative recurrence (Rutgeerts score ≥i2) and treated with VDZ after the baseline colonoscopy were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD). The primary outcome was endoscopic success, assessed at the first colonoscopy following initiation of VDZ and defined as reduction of at least one point of Rutgeerts score. The secondary outcome was clinical failure, assessed at one year and at the end of follow-up. RESULTS: Fifty-eight patients were included (mean follow-up: 24.8 ± 13.1 months). Endoscopic success was reported in 47.6% of patients. Clinical failure was reported in 19.0% of patients at one year, and in 32.8% of patients at the end of follow-up. A new resection was required in 7 patients (12.1%). CONCLUSIONS: VDZ may be an effective option for the treatment of postoperative recurrence of CD.

SPOSAB ABP 501: A Sicilian Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Adalimumab Biosimilar ABP 501.

BACKGROUND AND AIM: There are few clinical data on Adalimumab (ADA) biosimilars in inflammatory bowel disease. We aimed to perform a multicenter, observational, prospective study on safety and effectiveness of ADA biosimilar ABP 501 in patients with inflammatory bowel disease. METHODS: All consecutive patients from the cohort of the Sicilian Network for Inflammatory Bowel Disease treated with ADA biosimilar ABP 501 from February 2019 to February 2020 were enrolled. Patients were divided into three groups: group A, naïve to ADA and naïve to anti-tumor necrosis factors; group B, naïve to ADA and previously exposed to anti-tumor necrosis factors; and group C: switched from ADA originator to ABP 501. RESULTS: A total of 559 patients (median age 39 years; Crohn's disease 88.0%, ulcerative colitis 12.0%) were included, with a follow-up time of 403.4 patient-years. Thirty-six serious adverse events occurred in 36 patients (6.4%; incidence rate [IR]: 8.9 per 100 person-years [PY]). The IR of serious adverse events was higher among patients in group A compared with group C (17.4 vs 4.8 per 100 PY; IR ratio = 3.61; P < 0.001) and among patients in group B compared with group C (16.4 vs 4.8 per 100 PY; IR ratio = 3.42; P = 0.041). Among ADA-naïve patients (group A + B), 188 (85.8%) had a clinical response after 12 weeks, including 165 (75.3%) who achieved steroid-free remission. Higher treatment persistence estimates were reported for patients in group C compared with groups A and B (log-rank P < 0.001). CONCLUSIONS: Safety and effectiveness of ABP 501 seem to be overall similar to those reported for ADA originator. Switching from originator to ABP 501 was safe and effective.

The SPOSIB SB2 Sicilian Cohort: Safety and Effectiveness of Infliximab Biosimilar SB2 in Inflammatory Bowel Diseases, Including Multiple Switches.

BACKGROUND: No data on the recently introduced infliximab (IFX) biosimilar SB2 in inflammatory bowel disease (IBD) are available. METHODS: The Sicilian Prospective Observational Study of Patients With IBD Treated With Infliximab Biosimilar SB2 is a multicenter, observational, prospective study performed among the cohort of the Sicilian Network for Inflammatory Bowel Disease. All consecutive IBD patients starting the IFX biosimilar SB2 from its introduction in Sicily (March 2018) to September 2019 (18 months) were enrolled. RESULTS: Two hundred seventy-six patients (Crohn disease: 49.3%, ulcerative colitis: 50.7%) were included: 127 (46.0%) were naïve to IFX and naïve to anti-tumor necrosis factor medications (anti-TNFs), 65 (23.5%) were naïve to IFX and previously exposed to anti-TNFs, 17 (6.2%) were switched from an IFX originator to SB2, 43 (15.6%) were switched from the biosimilar CT-P13 to SB2, and 24 (8.7%) were multiply switched (from IFX originator to CT-P13 to SB2). The cumulative number of infusions of SB2 was 1798, and the total follow-up time was 182.7 patient-years. Sixty-seven serious adverse events occurred in 57 patients (20.7%; incidence rate: 36.7 per 100 patient-year), and 31 of these events caused the withdrawal of the drug. The effectiveness after 8 weeks of treatment was evaluated in patients naïve to IFX (n = 192): 110 patients (57.3%) had steroid-free remission, while 56 patients had no response (29.2%). At the end of follow-up, 72 patients (26.1%) interrupted the treatment, without significant differences in treatment persistency estimations between the five groups (log-rank P = 0.15). CONCLUSIONS: The safety and effectiveness of SB2 seem to be overall similar to those reported for the IFX originator and CT-P13.

Feasibility of using E-mail counseling as part of a smoking-cessation program.

BACKGROUND: The need for more effective smoking-cessation interventions is firmly established. However, access to these services can be problematic in real life. E-mail messages may be a convenient alternative to deliver smoking-cessation interventions. The aim of this pilot study was to assess the effectiveness of incorporating tailored e-mail consultation messages in a smoking-cessation program for smokers willing to quit. METHODS: This pilot study examined the feasibility of integrating e-mail consultation messages in a smoking-cessation program for smokers willing to quit and with Internet access. At baseline, demographic data, smoking history and expired carbon monoxide (CO) levels were collected at a clinic visit. The subjects were provided with the specialist's e-mail address and instructed to prepare e-mail messages containing simple and clear information about their quitting progress. The counselor offered e-mail counseling throughout the smoking-cessation program. A 6-month follow-up visit was arranged, at which abstinence was reviewed. RESULTS: Of the 30 participants initially enrolled in the study, 21 (70%) attended the follow-up 6-month visit. E-mail counseling was more frequently offered (4-8 times) to the participants who completed the study, compared to those lost to follow-up (1-4 times). Comparisons with baseline exhaled CO values showed a significant within-group reduction at 6 months after smoking-cessation (P < .001) in the quitters, compared to smoking-cessation failures. Sustained smoking abstinence at 6 months was 37%. CONCLUSIONS: The integration of e-mail consultation counseling in a smoking-cessation intervention is feasible and effective. E-mail counseling as part of a smoking-cessation program warrants further evaluation.

Cigarette smoking is associated with a greater risk of incident asthma in allergic rhinitis.

BACKGROUND: Asthma and rhinitis are often comorbid conditions, and several studies have suggested that rhinitis often precedes asthma. Sensitization to allergen has been shown to be one of the strongest determinants of incident asthma, but little is known about the effects of cigarette smoking among individuals with allergic rhinitis. OBJECTIVE: We sought to evaluate the importance of cigarette smoking as an additional risk factor for incident asthma in a cohort of hospital-referred nonasthmatic adult subjects with allergic rhinitis. METHODS: The study population selected at baseline was invited for a follow-up visit 10 years later to check for possible asthma features. Categories of smokers, exsmokers, and never smokers were used in the analyses together with pack-years to calculate the level of cumulative exposure. RESULTS: Complete data were available from 325 patients. Smoking was significantly related to the risk of incident asthma, with the odds ratio (OR) being 2.67 (95% CI, 1.70-4.19) for univariate and 2.98 (95% CI, 1.81-4.92) for multivariate analyses. A clear dose-response association for exposure to tobacco and risk of new-onset asthma was observed in the multivariate analyses: those with 1 to 10 pack-years had an OR of 2.05 (95% CI, 0.99-4.27), those with 11 to 20 pack years had an OR of 3.71 (95% CI, 1.77-7.78), and those with 21 or more pack-years had an OR of 5.05 (95% CI, 1.93-13.20) compared with never smokers. CONCLUSIONS: The current findings support the hypothesis that cigarette smoking is an important independent risk factor for the development of new asthma cases in adults with allergic rhinitis.

Changes in airway hyperresponsiveness following smoking cessation: comparisons between Mch and AMP.

BACKGROUND: Given the observed association between smoking, inflammation and airway hyperresponsiveness (AHR) one may predict that smoking cessation may improve AHR. However, only a few studies have investigated the effect of smoking on AHR and their results appear to be conflicting depending on the stimulus used in their bronchoprovocation protocol. The aim of the current study was to compare changes in AHR between direct (methacholine (Mch)) and indirect (adenosine 5'monophosphate (AMP)) stimuli before and at different time points after smoking cessation in smokers with allergic rhinitis (+/-asthma). METHODS: We have prospectively studied changes in AHR to inhaled Mch and AMP in smokers with allergic rhinitis (+/-asthma), before and at 6 and 12 months after smoking cessation. RESULTS: It was found that 28% (16/57) of the participants had quit smoking by the end of the study. No significant change in AHR was observed in smoking cessation failures. A significant improvement in AHR to AMP but not Mch was observed 6 months after smoking cessation in quitters; a 1.2 doubling concentrations change in PC20 AMP was measured whereas only a 0.4 doubling concentrations change was observed for PC20 Mch. However, after 12 months smoking cessation the improvement in AHR became significant for both AMP and Mch, their dose-response curves being displaced to the right to a similar extent (1.4 and 1.1 doubling concentrations for AMP and Mch, respectively). CONCLUSION: Smoking cessation can improve AHR in smokers who quit with a 6 months improvement being reported for the airways response to AMP but not Mch. AMP challenge may detect earlier changes in AHR in smokers during smoking cessation.

Eighteen needles to forget...an unnamed past.

Lasthénie de Ferjol syndrome is a very rare psychiatric illness that occurs mainly in women. It is characterized by severe recurrent iron-deficiency anemia caused be repeated episodes self-induced blood-letting. We report the case of a young homosexual male repeatedly admitted to various hospitals for severe hypochromic anemia. We discovered that the anemia was indeed due to psychotic self-provoked hemorrhages. Based on this experience and a review of the few cases reported in the literature, we discuss issues of early diagnosis, management and treatment of Lasthénie de Ferjol patients.

Greater risk of incident asthma cases in adults with allergic rhinitis and effect of allergen immunotherapy: a retrospective cohort study.

Asthma and rhinitis are often co-morbid conditions. As rhinitis often precedes asthma it is possible that effective treatment of allergic rhinitis may reduce asthma progression. The aim of our study is to investigate history of allergic rhinitis as a risk factor for asthma and the potential effect of allergen immunotherapy in attenuating the incidence of asthma. Hospital-referred non-asthmatic adults, aged 18-40 years between 1990 and 1991, were retrospectively followed up until January and April 2000. At the end of follow up, available subjects were clinically examined for asthma diagnosis and history of allergen specific immunotherapy, second-hand smoking and the presence of pets in the household. A total of 436 non-asthmatic adults (332 subjects with allergic rhinitis and 104 with no allergic rhinitis nor history of atopy) were available for final analyses. The highest OR (odds ratio) associated with a diagnosis of asthma at the end of follow-up was for the diagnosis of allergic rhinitis at baseline (OR, 7.8; 95%CI, 3.1-20.0 in the model containing the covariates of rhinitis diagnosis, sex, second-hand smoke exposure, presence of pets at home, family history of allergic disorders, sensitization to Parietaria judaica; grass pollen; house dust mites; Olea europea: orchard; perennial rye; and cat allergens). Female sex, sensitization to Parietaria judaica and the presence of pets in the home were also significantly predictive of new onset asthma in the same model. Treatment with allergen immunotherapy was significantly and inversely related to the development of new onset asthma (OR, 0.53; 95%CI, 0.32-0.86). In the present study we found that allergic rhinitis is an important independent risk factor for asthma. Moreover, treatment with allergen immunotherapy lowers the risk of the development of new asthma cases in adults with allergic rhinitis.

Two clinical cases of insulinoma misdiagnosed as psychiatric conditions.

We describe the clinical cases of two male subjects, respectively 73 and 41 years old, affected with insulinoma, misdiagnosed for many years as psychiatric subjects and scarcely responsive to therapy with benzodiazepins, antidepressants and antiepileptics. Although Whipple's triad was satisfied in both subjects since the onset of symptoms, they had to wait a long time for the correct diagnosis and appropriate treatment. Once the surgical therapy was carried out, our subjects recovered totally and ended the psycho-drugs.

A catastrophic case of skin gangrene.

We describe the case of a 70-year-old male with the catastrophic antiphospholipid syndrome admitted for skin gangrene of the fingers. The initial diagnosis was antiphospholipid antibody syndrome in a patient with rheumatoid arthritis and a history of deep vein thrombosis of the lower limbs. Liver involvement, the characteristic skin gangrene, pneumonia and worsening severe renal failure were determinant to make the final diagnosis of catastrophic antiphospholipid syndrome that led the patient to death.

Six clinical cases of Mandragora autumnalis poisoning: diagnosis and treatment.

A multiple case of Mandragora autumnalis poisoning is described. Mandragora autumnalis, a solanaceous plant that is common in the Sicilian countryside, contains a variable concentration of solanum alkaloids, which cause gastrointestinal irritation, and tropane alkaloids, which have anticholinergic properties and produce typical and sometimes severe atropine-like symptoms. Vital function support, decontamination, symptomatic treatment and, in severe cases, antidote therapy with physostigmine are useful to control acute poisoning.