Real world use of biological drugs in patients with psoriasis/psoriatic arthritis: a retrospective, population-based study from Southern Italy in the years 2010-2014

BACKGROUND: Biological drugs, such as infliximab, etanercept, adalimumab, ustekinumab, golimumab and certolizumab are third-line therapy for psoriasis (PsO) and psoriatic arthritis (PsA), but they may be used at earlier stage in severe forms. This study investigated the pattern of use and costs of biological drugs for PsO/PsA in a large population from Southern Italy during the years 2010-2014. METHODS: This was a retrospective, population-based, drug-utilization study, using healthcare administrative databases of the ASL (Local Health Unit) and two hospitals of Messina Province (Sicily) in the years 2010-2014. Incident users of adalimumab, ustekinumab, infliximab, etanercept and golimumab for PsO/PsA were characterized. Yearly prevalence of use and costs, as well as time to treatment discontinuation and switch were assessed. RESULTS: During the study period, 517 patients received at least one study drugs prescription for PsO/PsA and 304 (58.8%) were incident users, mostly treated with adalimumab (33.6%). Incident users were mostly males (59.8%), with a median age of 49 years. The prevalence of biological drugs users in PsO/PsA increased from 4.3 to 6.9 per 10,000 inhabitants from 2011 to 2014. Pharmaceutical expenditure of the study drugs almost doubled (from 2.6 to 4.7 million euros over 5 years of observation). During the first year of treatment, discontinuation occurred in 31.8% of incident users and switch was not infrequent (7.4%). CONCLUSIONS: Prevalence of use and costs of biological drugs for PsO/PsA substantially increased in recent years in a large population of Southern Italy. Larger uptake of lowest cost biological drugs, and biosimilars whenever available, may help access to the most innovative drugs

Proceedings of the Closed Round Table and Italian Consensus on the Medication-Related Osteonecrosis of Jaws (MRONJ) at the Symposium of Italian Society of Oral Pathology and Medicine (SIPMO) Ancona, 20 October 2018 - Part II

none22nononeCampisi, Giuseppina; Bedogni, Alberto; Bertoldo, Francesco; Bettini, Giordana; Biasotto, Matteo; Colella, Giuseppe; Consolo, Ugo; Di Fede, Olga; Favia, Gianfranco; Fusco, Vittorio; Gabriele, Mario; Lo Casto, Antonio; Lo Russo, Lucio; Marcianò, Antonia; Mauceri, Rodolfo; Meleti, Marco; Mignogna, Michele; Oteri, Giacomo; Panzarella, Vera; Romeo, Umberto; Santarelli, Andrea; Vescovi, PaoloCampisi, Giuseppina; Bedogni, Alberto; Bertoldo, Francesco; Bettini, Giordana; Biasotto, Matteo; Colella, Giuseppe; Consolo, Ugo; Di Fede, Olga; Favia, Gianfranco; Fusco, Vittorio; Gabriele, Mario; Lo Casto, Antonio; Lo Russo, Lucio; Marcianò, Antonia; Mauceri, Rodolfo; Meleti, Marco; Mignogna, Michele; Oteri, Giacomo; Panzarella, Vera; Romeo, Umberto; Santarelli, Andrea; Vescovi, Paol

ERas and COLorectal endoscopic surgery: an Italian society for endoscopic surgery and new technologies (SICE) national report

Background Several reports demonstrated a strong association between the level of adherence to the protocol and improved clinical outcomes after surgery. However, it is difficult to obtain full adherence to the protocol into clinical practice and has still not been identified the threshold beyond which improved functional results can be reached. Methods The ERCOLE (ERas and COLorectal Endoscopic surgery) study was as a cohort, prospective, multi-centre national study evaluating the association between adherence to ERAS items and clinical outcomes after minimally invasive colorectal surgery. The primary endpoint was to associate the percentage of ERAS adherence to functional recovery after minimally invasive colorectal cancer surgery. The secondary endpoints of the study was to validate safety of the ERAS programme evaluating complications' occurrence according to Clavien-Dindo classification and to evaluate the compliance of the Italian surgeons to each ERAS item. Results 1138 patients were included. Adherence to the ERAS protocol was full only in 101 patients (8.9%), > 75% of the ERAS items in 736 (64.7%) and > 50% in 1127 (99%). Adherence to > 75% was associated with a better functional recovery with 90.2 +/- 98.8 vs 95.9 +/- 33.4 h (p = 0.003). At difference, full adherence to the ERAS components 91.7 +/- 22.1 vs 92.2 +/- 31.6 h (p = 0.8) was not associated with better recovery. Conclusions Our results were encouraging to affirm that adherence to the ERAS program up to 75% could be considered satisfactory to get the goal. Our study could be considered a call to simplify the ERAS protocol facilitating its penetrance into clinical practice