Introduction
The prevalence of ulcerative colitis (UC) in elderly patients is rising and is associated with aging-related challenges such as functional reserve decline, compromised immune responses, and comorbidities. Anti-TNF agents and vedolizumab are effective therapies for UC but may also be associated with increased risk in elderly patients. Therefore, it is challenging to choose a first-line biologic therapy (FLBT) and data regarding FLBT for the aging population are scarce.
Aims & Methods
Our aim was to compare the safety, and persistence on drug of elderly patients with UC treated with anti-TNF agents compared to vedolizumab as first-line therapy.
Methods: This was a retrospective, single tertiary center study, including all patients with UC who initiated their FLBT at age≥60 years, between 1/1/2010 to 31/12/202. Clinical and demographic data were extracted and adverse events occurring within 52 weeks of treatment initiation were recorded.
Results
A total of 264 patients with UC aged ≥60 years were screened,62 patients were included in the final analysis [35 males (56.4%), age 68.9±7.0 years, disease duration 12.1±13.1 years]. Anti-TNF was the FLBT for 33 patients (53.2%) and vedolizumab for 29 patients (46.8%). Disease duration, gender, smoking status, concomitant exposure to steroids, concomitant use of IMM were comparable between the groups. Patients treated with an anti-TNF had a significantly lower CCI (4.9±1.86vs. 3.7±2.0, p=0.017) and more severe endoscopic disease (2.5±0.8 vs. 2.2±0.6, p=0.009) (Table 1).
Overall, at 52 weeks of follow-up, 6 patients had an adverse event. 4 patients suffered from infections:1 patient treated with Anti-TNF had severe pneumonia and needed hospitalization, 2 patients treated with vedolizumab had CMV infection and needed treatment cessation until resolution of CMV and another patient treated with vedolizumab, with known metastatic disease (CCI=10), died due to sepsis (week 17). No de-novo or recurrent malignancy were observed. One patient on vedolizumab had a skin rash treated with antihistamines and did not require treatment cessation, another patient on infliximab stopped treatment due to anaphylaxis. There were similar rates of hospitalizations between the cohorts (39.4% vs.17.2%, respectively, p=0.230). In terms of treatment persistence, median time on anti-TNF was similar to that on vedolizumab (32.00 weeks [20.00-80.57, n=13] vs 45.07 weeks [24.39-155.60, n=28] (p=0.324), respectively).
Table 1: Characteristics of study cohort
| | Anti TNF (n=33) | Vedolizumab(n=29) | |
| Male gender (%) | 18 (54.45) | 17 (58.62) | 0.801 |
| Disease duration (y) | 10.45±10.55 | 13.93±15.47 | 0.301 |
| Steroids(%) | 18(54.5) | 14(48.2) | 0.696 |
| IMM(%) | 9(27.2) | 2(6.8%) | 0.194 |
| Mayo score | 2.53±0.8 | 2.26±0.6 | 0.009 |
| CCI | 3.75±2.01 | 4.96±1.86 | 0.017 |
| SCCAI | 8.2±3.4 | 7.2±3.4 | 0.614 |
| ^CRP(mg\L) | 8.1 [1.27-18.10] | 10.9 [2.55-37.75] | 0.466 |
| ^Calprotectin(μg/g) | 1392.5 [389.00-2750.00] | 618.0 [281.75-1100.75] | 0.367 |
*Anti TNF group included 21 patients on infliximab and 12 patients on Adalimumab; Plus-minus values are means ±SD, 5-ASA=5 aminosalicylic acid, IMM=immunomodulators(methotrexate, azathioprine,6-mercaptopurine),y=years
^CRP and calprotectin are calculated as medians with IQR in [].
Conclusion
Anti-TNF and vedolizumab are equally safe as first-line biologic therapy among elderly patients with UC indicating that other factors may guide therapy selection in this patient population. Further prospective and larger studies are needed to fortify our findings.
Disclosure
I hereby certify that neither i and to the best of my knowledge nor anyone of the co-authors has something to disclose