Efficacy and Safety of Biological Therapies and JAK Inhibitors in Older Patients with Inflammatory Bowel Disease

Abstract

With the introduction of more and more monoclonal antibodies selectively targeting various mediators of the immune system, together with Janus-Kinase (JAK)-inhibitors with variable affinities towards different JAK subtypes, the available therapeutic options for the treatment of inflammatory bowel diseases (IBD) have undergone an acceleration in the last five years. On the other hand, the prevalence of IBD patients over 65-years-old is steadily increasing, and, with this, there is a large population of patients that presents more comorbidities, polypharmacy, and, more frequently, frailty compared to younger patients, exposing them to potentially major risks for adverse events deriving from newer therapies, e.g., infections, cardiovascular risks, and malignancies. Unfortunately, pivotal trials for the commercialization of new therapies rarely include older IBD patients, and those with serious comorbidities are virtually excluded. In the present review, we focus on existing literature from pivotal trials and real-world studies, analyzing data on efficacy/effectiveness and safety of newer therapies in older IBD patients with special emphasis on comorbidities and frailty, two distinct but intercorrelated aspects of the older population since age by itself seems to be of minor importance.

Keywords: Crohn’s disease; comorbidities; frailty; infections; malignancies; ulcerative colitis.

Figure 1

Real-world studies on the effectiveness of biological therapies in elderly and adult IBD patients. The most representative endpoint of each study was selected. Data are expressed as percentages according to different outcomes. SFR = steroid-free remission, SFP = steroid-free persistence, FU = follow-up, MH = mucosal healing, naïve: Patients without prior biologic treatment, studies including a younger control group of patients treated with the same biologic drug are represented with parallel bars, studies comparing different therapeutic drugs are allocated to the respective column, Ref [36] was excluded because only treatment failure was calculated [30,31,32,33,37,38,39,40,41,42,43,44,45,46,47,48].