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Background Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce. We compare the efficacy and safety of ADA biosimilars SB5, APB501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting. Methods A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn’s disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti–tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars. Results A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint. Conclusions Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars.

Background and Aims: Adalimumab (ADA) biosimilars have been included into the therapeutic armamentarium of inflammatory bowel disease (IBD); however, comparative data on the efficacy and safety of the different ADA biosimilars after replacing the ADA originator for a non-medical reason remains scarce. We aimed to compare in a real-life setting the efficacy and safety of four ADA biosimilars SB5, APB501, GP2017, and MSB11022 in IBD patients after replacing the originator for a non-medical reason. Methods: A multicenter retrospective study was performed on consecutive IBD patients, analyzing clinical, laboratory, and endoscopic data. The primary endpoints of the study were maintenance of clinical remission and safety of the different biosimilars. Results: 153 patients were enrolled, 26 with UC and 127 with CD. Clinical remission was maintained in 124 out of 153 (81%) patients after a median (IQR) follow-up of 12 (6–24) months, without any significant difference between the four ADA biosimilars. ADA biosimilars dosage was optimized in five patients (3.3%). Loss of remission was significantly higher in UC patients (10/26 patients, 38.5%) than in CD patients (19/127 patients, 14.9%, p<0.025). Adverse events occurred in 12 (7.9%) patients; the large majority were mild. Conclusions: No difference in efficacy and safety was found between ADA biosimilars when used to replace the ADA originator for a non-medical reason. However, in UC patients the replacement of ADA originator for this reason should be carefully assessed.

The aim of this study was to evaluate somatic cell count (SCC), prevalence and etiology of mastitis in a dairy buffalo herd from Analândia, São Paulo State, Brazil, in the dry and rainy seasons. Additionally, antimicrobial susceptibility profile of microorganisms isolated from milk samples was also evaluated. 1,042 milk samples from female Murrah buffaloes in a dairy farm located in Analândia, São Paulo State, Brazil, collected between May 2011 and November 2012 were analyzed. After the mammary gland physical examination, strip cup test and California Mastitis Test (CMT) were performed. Afterwards, 50mL of milk samples from each mammary quarter were collected aseptically for SCC in automatic equipment and microbiological examination. The antimicrobial sensitivity profile to ampicillin, cefoperazone, ceftiofur, enrofloxacin, gentamicin, neomycin, oxacillin, penicillin, and sulfamethoxazole/trimethoprim was evaluated by disk diffusion method. The monthly average temperature and pluviometric index were obtained from "Centro Integrado de Informações Agrometeorológicas" (CIIAGRO) of "Instituto Agronômico de Campinas" (IAC). Milk samples with positive results in the microbiological test showed average SCC of 137,720 cells/mL in the dry period and 190,309 cells/mL in the rainy period. Although a higher number of isolated microorganisms was observed in buffalo milk samples during the rainy period (69/600) compared to the dry period (50/442), the season had no significant effect on the frequency of isolation of microorganisms.