A retrospective analysis of treatment patterns, drug discontinuation and healthcare costs in Crohn's disease patients treated with biologics.

BACKGROUND/AIMS: This real-world analysis evaluated the persistence and direct healthcare costs of Crohn's Disease (CD) patients treated with biologics in Italy. METHODS: A retrospective analysis on administrative databases of Italian healthcare entities, covering 10.4 million residents, was performed. Adult CD patients under biologics between 2015 and 2020 were included and attributed to first/second treatment line based on absence/presence of biologic prescriptions 5-years before index-date (first biologic prescription). RESULTS: Of 16,374 CD patients identified, 1,398 (8.5%) were biologic-treated: 1,256 (89.8%) in first line and 135 (9.7%) in second line. Kaplan-Meier curves estimated a higher persistence for ustekinumab-treated patients followed by vedolizumab, infliximab and adalimumab, in both lines. Considering baseline variables and adalimumab as reference, infliximab in first line (HR: 0.537) and ustekinumab in first (HR: 0.057) and second line (HR: 0.213) were associated with significantly reduced risk of drug-discontinuation. First line total/average healthcare direct-costs were €13,637, €11,201, €17,104 and €18,340 in patients persistent on adalimumab, infliximab, ustekinumab and vedolizumab, respectively. CONCLUSIONS: This real-world analysis showed differences in persistence over 12-months between biologic treatments, being higher in ustekinumab-treated group, followed by vedolizumab, infliximab and adalimumab. Patients' management was associated with comparable direct healthcare costs among treatment lines, mainly driven by drug-related expenses.

Effectiveness End Points in Real-World Studies on Biological Therapies in Psoriasis: Systematic Review with Focus on Drug Survival.

Psoriasis is a complex and chronic disease, and, in most cases, therapies are required during all patients' lifetime. The efficacy and safety profiles of biological therapies are well established, but their effectiveness is still open to discussion. We performed a systematic review to summarize how the effectiveness of biological therapies for psoriasis is measured in real-world studies and to understand whether drug survival, a recent alternative outcome to clinical ones, is a recurrent and valid outcome of effectiveness. In March 2017, we searched for quantitative epidemiological data of psoriasis treatments using PubMed/Medline and EMBASE, and we included 65 publications. The retrospective study design (37%) was most frequent, followed by prospective registries (29%), prospective studies (19%), and retrospective administrative databases/claims. Drug survival was reported in over 60% of prospective registries and retrospective studies, and less frequently in prospective studies. A general consensus emerged in the definition of drug survival as the time patients remain under treatment with a specific therapy, and in its interpretation as an overall marker of treatment success and treatment adherence, as it represents simultaneously information on drug efficacy, drug safety, and patient satisfaction. In conclusion, notwithstanding some limitations, drug survival is a useful measurement of biological therapy effectiveness for psoriasis in daily practice. Its major advantage is that it can be computed also in already collected databases without any specific clinical information on psoriasis. This outcome, combined with evidence on clinical markers of effectiveness, can contribute to better understanding the performance of this expensive class of drugs.

Crohn's disease in Italy: A critical review of the literature using different data sources.

BACKGROUND: Incidence and prevalence of Crohn's disease (CD) have increased during the last decades in several world areas. Italian data on CD are scattered between various administrative, educational and scientific sources, and findings are poorly summarized. AIMS: We conducted a review focusing not only on prevalence and incidence of CD in Italy, but also on mortality, treatments, delayed diagnosis and hospitalization. METHODS: In October 2015, we searched for quantitative epidemiological data of CD using PubMed/Medline, EMBASE, and the Cochrane Database of Systematic Reviews. We also conducted searches on selected web resources for databases and educational publications. RESULTS: Sixteen studies reporting data on incidence of CD from Italy were found. Incidence rates of CD in the early 2010's in Italy were 3.5-4 cases per 100,000 inhabitants per year. Ten investigations provided data on CD prevalence, with large variability between Italian areas. Most studies considering data at two or more time points or across consecutive time periods reported increasing incidence or prevalence of CD. CONCLUSION: This review of Italian epidemiological data indicates that CD incidence and prevalence are continuing to (moderately) increase. Diagnostic delay, treatments, hospitalization and surgery for CD in Italy were also reviewed and quantified, though information is somewhat limited.