Background Biological treatments used for the treatment of inflammatory bowel disease (IBD) have demonstrated their efficacy and safety, although these results were obtained from studies that mostly include young people generally included in clinical trials. The objective of our study is to assess the efficacy of these treatments in the elderly population in real life Methods Patients have been retrospectively included with established diagnosis of IBD aged 65 years or older at the time of initiating biological treatment(Infliximab, Adalimumab, Golimumab, Ustekinumab or Vedolizumab).Among the patients included, the clinical response (at the discretion of the researcher)after induction(around 12 weeks of treatment)and at 52 weeks was assessed.When that were available, the data related to endoscopic response at week 52 were collected(endoscopic activity was classified as moderate, mild or severe, according to the researcher) Results A total of 1090 patients were included(707 CD and 383 UC).The indication for biologic in our experience was lack of response to immunosuppressants(292, 27.1%), corticodependence(318, 29.5%), perianal disease(31, 2.9%), treatment for postoperative recurrence(76, 7.0%), severe corticorefractory ulcerative colitis(59, 5.5%), others(303, 28.1%).After induction, at approximately 12–14 weeks of treatment, 419(39.6%) were in clinical remission, 502(47.4%) had a response without remission, and 137 patients(12.9%) had no response.The percentages of remission with the different biologics were: infliximab 159 patients(42.6%), adalimumab 118 patients (38.4%), golimumab 9 patients(32.1%), ustekinumab 50(32.7%), vedolizumab 84(40.6%)(p = 0.3).At 52 weeks of treatment 442 patients(50.63%) clinical remission, 249 patients had a response (28.5%) and 53 patients had no response (6.1%). Before one year of treatment, 129 patients(14.8%) had suspended treatment due to ineffectiveness, being significantly higher(p <0.0001) for golimumab 9 patients(37.5%) compared to the rest of the biological treatments analyzed.We analyzed the percentages of clinical response to the different biological treatments, without identifying statistically significant differences between the remission rates: infliximab 160 (51.3%), adalimumab 131(50.9%), golimumab 10(41.7%), ustekinumab 49(44.9%) and vedolizumab 92(53.8%).In colonoscopy at 52 weeks(performed 218 patients), 35.8% endoscopic remission(78 patients), 32.1% mild activity(70 patients), 26.1% moderate activity(57 patients) and 6.0% severe activity(13 patients). Conclusion Biological drugs have response rates in elderly patients similar to those described in the general population. In our experience, golimumab was the drug that had to be discontinued most frequently due to ineffectiveness.

Background Biological drugs are being increasingly used for the treatment of inflammatory bowel diseases (IBD) in elderly patients. Despite the particular characteristics of this population subgroup, the efficacy and safety of these treatments in real clinical practice is poorly evaluated. Methods Retrospective and multicenter study of GETECCU, carried out in 28 Spanish hospitals. Patients with IBD who started biological treatment (Infliximab, Adalimumab, Golimumab, Ustekinumab or Vedolizumab) aged 65 years or older were included. Efficacy (clinical- at the criteria of the responsible physician-, biochemical and endoscopic) was assessed at 12-14 weeks and at 52 weeks of treatment. Adverse effects such as tumors or serious infections were also recorded. Results A total of 570 patients were included, baseline characteristics are shown in Table 1. Biologics used were: Infliximab (214, 37.5%), Adalimumab (167, 29.3%), Golimumab (16, 2.8%), Ustekinumab (73, 12.8%) and Vedolizumab (100, 17.5%). After 12-14 weeks of treatment, in 38.7% (220) of the cases clinical remission had been achieved and in 47.7% (270) there was clinical response without remission. However, 80 patients (13.9%) had no response, resulting in treatment discontinuation due to primary failure. At week 52, only 379 patients (66.5%) continued on biological treatment: 216 (57%) were in clinical remission (216, 57.0%) while 129 (34%) had response without remission and 34 (9%)had no response. In addition, 119 patients (21%) had an endoscopic study performed: 47 (39,5%) presented with endoscopic remission, 38 (31,9%) with mild activity, 28 (23,5%) with moderate activity and 6, (5.1%) with severe activity. At the end of the follow-up, only 60% of the patients continued on biological treatment, being the reason for withdraw lack of efficacy or due to the report of adverse side effects. Regarding treatment safety in this population, 12.1% (68 patients) suffered an infectious complication with a microbiological diagnosis, requiring hospitalization in 62.1% of the cases. In addition, 39 patients (6.9%) were diagnosed with a tumor until the end of the follow-up, noting that 34.2% of the cases continued on biological therapy after the diagnosis. Likewise, in 25 patients (36.8%) this infection forced discontinuation of biological treatment. Finally, 10 patients stopped biological treatment due to a serious adverse reaction to it Conclusion Response rates to biological treatment in elderly patients are similar to those described in the general population, with approximately one third of failures happening during the first year. However, a remarkable proportion of patients developed a serious adverse effect that could be related to treatment

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Background The most feared adverse events related to biological treatment in patients with inflammatory bowel disease (IBD) are the development of tumors and / or serious infections. These events are generally more frequent in elderly patients, so the increased use of biological drugs in these patients today makes it necessary to assess the safety of these drugs in this population. Methods Patients have been retrospectively included with established diagnosis of IBD at age, 65 at the time of initiating biological treatment(Infliximab, Adalimumab, Golimumab, Ustekinumab or Vedolizumab).Data regarding the development of oncological events during treatment have been collected. Variables related to infectious processes during biological treatment have also been included, documented by microbiological analysis and requiring systemic treatment and / or hospitalization(excluding bowel infection by CMV). Statistical analysis was performed with Stata, 15.0,categorical variables were compared with the chi2 test for proportions Results 1090 patients have been retrospectively included. Regarding the development of tumors, we observed an oncological event in, 74 (6.9%). They developed in, 30 patients (8%) with infliximab, 23 patients (7.1%) with adalimumab, 3 patients(11.1%) with golimumab, 10 patients (6.4%) with ustekinumab, and, 8 (3, 8%) vedolizumab. It was significantly lower(p = 0.04) for the vedolizumab group compared to other treatments, however, statistical significance was not reached for the ustekinumab group (p = 0.5)., 31% (23 patients) had an oncological history prior to the start of the biological treatment under study. The most frequently developed tumors were cutaneous, not melanocytic in, 10 patients, lung in, 10 patients and hematological tumors (7 non-Hodgkin lymphoma, 3 acute leukemias and, 2 intestinal lymphomas), 7 bladder tumors, 5 prostate and, 4 colorectal carcinoma.Regarding the development of infections, these occurred in, 160 patients during biological treatment(14.9%), without differences between the different biological drugs used (p = 0.61): infliximab, 61,(19.4%), adalimumab, 39 (12.5%), golimumab, 5(17.8%), ustekinumab, 22(14.1%), and vedolizumab, 34 (16.5%).Likewise, 85 (53.1%) require hospitalization due to the infectious process and in, 51(31.9%), it is permanently suspended due to the infection.Until the end of the follow-up, 158 patients (36.4%) suspended the biological drug due to an adverse effect, with the time until suspension:, 1.47 years(mean); SD:1.6 Conclusion In our experience, the development of tumors is more frequent in patients who use anti-TNF compared to other targets, although its incidence is generally low. However, there are no differences in the development of infections between the different biological treatments.

Background The use of biological drugs for the treatment of IBD in elderly patients is becoming more frequent in our environment. However, given the greater risk of these patients to develop related adverse effects, the profile of the patients in whom it is applied and the type of drug to choose, has not been established. Methods Patients have been retrospectively included with established diagnosis of IBD UC, CD or indeterminate colitis (IC) by usual criteria (clinical, laboratory, endoscopic, radiological and / or histological) 65 years at the time of initiating biological treatment (Infliximab, Adalimumab, Golimumab, Ustekinumab or Vedolizumab) and that they have received at least the induction doses. Variables corresponding to the baseline characteristics of the patients have been collected, as well as data referring to the characteristics of IBD that have been considered relevant for the study. We calculated the comorbidity of the patients using the Charlston index The statistical analysis was completed using Stata 15.0. For continuous variables, after checking the normality of the distribution, were compared using t Student and categorical variables chi2 test for proportions Results 1090 biological treatments started in patients aged 65 years or older have been retrospectively included. The baseline characteristics are summarized in TABLE 1 and those related to his IBD in TABLE 2.most used treatments in order of frequency were: Infliximab (377, 34.8%), Adalimumab(311, 28.7%),Golimumab (28, 2.6%), Ustekinumab (157, 14.5%) and Vedolizumab (209, 19.3%). It should be noted that most of the patients had monotherapy treatment, finding only 27.7% (299 patients) combined with immunosuppressants (IMS) (thiopurines in 72.9% of cases). Identify 705 patients (64.8%) had a Charlston score = <1 (absence of comorbidity), 219 patients (20.13%) 2 points (low comorbidity) and 164 (15.07%) score => 3 points (high comorbidity). It was objective that the choice of the type of biological could be conditioned by the presence of comorbidity, presenting 22% of the patients (66 cases) who opted for Ustekinumab / vedolizumab high comorbidity versus 15% of patients with antiTNF (98 cases) with high comorbidity. (p = 0.012). It was investigated whether the antecedent of neoplasia influenced the choice of biological treatment, finding that 47% of the cases (72 patients) opted for antiTNF and in 53% (80 patients) by ustekinumab / vedolizumab, these differences being statistically significant(p <0.0001) Conclusion In our experience, biological drugs with different therapeutic targets are used in elderly patients, generally in non-frail patients.The use of more specific treatments(ustekinumab, vedolizumab)is preferred in those with greater associated comorbidity