Introduction
Long-term real-life data on vedolizumab (VDZ) are scarce. In this study, we aim to evaluate the long-term outcomes of patients (pts) with inflammatory bowel disease (IBD) who received VDZ.
Aims & Methods
The LONG-LIVE is the long-term extension (LTE) of the LIVE study, including IBD pts who had started VDZ from 04 to 06/2017 at 47 Italian centres affiliated with IG-IBD, prospectively followed-up to 06/2019. For this study, data on therapy withdrawal, clinical and endoscopic activity, need for surgery/hospitalizations, deaths, and serious adverse events (SAEs) were retrospectively extracted from 07/2019 up to the last available follow-up (fup).
Results
Seven hundred eighty-two (70% of the original cohort) pts were enrolled in the LTE (394 CD, 388 UC), 316 (40%) of whom had already definitively discontinued VDZ; 43% were female, mean age was 53±16 years, mean disease duration was 17±9 years, 76% of patients were bioexposed to anti-TNFα therapy. Among the remaining 466 still receiving VDZ, 204 (44%) subsequently suspended VDZ permanently and 9 (2%) temporarily: mean VDZ therapy duration was 113±92 weeks and 311±60 weeks among those who suspended and those who continued VDZ, respectively. Mean therapy duration was 177±124 weeks (172±124 weeks for CD and 182±125 weeks for UC, with no significant differences); longer mean persistence was observed in bionaive vs bioexposed CD pts (197±123 vs 182±122 weeks, p<0.05), while no such difference was observed in UC pts (193.1±126 vs 190±122. week, p=ns). Among CD pts who continued VDZ throughout the entire LTE, 74% and 54% were in clinical and endoscopic remission, respectively, at the last fup; among UC pts who continued VDZ throughout the entire LTE, 79% and 50% were in clinical and endoscopic remission, respectively, at the last fup. During the LTE, CD pts had a higher risk of IBD-related hospitalizations (Hazard Ration, HR, 1.37, 95% Confidence Interval, CI, 1.04-1.72, p=0.027). Specifically, 153 (20%) pts (83 CD, 70 UC) were hospitalized to receive IBD-related surgery after a mean time of 136±87 weeks from VDZ start (for CD vs UC comparison, HR 1.17, 95% CI 0.85-1.60, p=ns); 85 (11%, 54 CD, 31 UC) pts underwent IBD-related hospitalization for non-surgical reasons (CD vs UC, HR 1.71, 95% CI 1.21-2.62, p=0.015). New or recurrent cancers were reported in 17 pts (the most common localization being 4 breast cancers and 3 gastrointestinal cancers): mean interval between first VDZ administration and cancer diagnosis was 214 (±95) weeks; 20 non-oncological SAEs were recorded in pts receiving VDZ, the most common being infections (n=7), mostly pneumonia (n=4). Finally, 15 deaths were reported (of which 9 occurred in patients still receiving VDZ); the most common causes of death were infections (n=5), cardiovascular diseases (n=5) and cancer (n=3).
Conclusion
About one-third of pts were still receiving VDZ after a fup of more than 6 years, with the majority of them being in clinical remission and more than 50% also having quiescent endoscopic activity at the last observation; bionaive CD patients had longer persistence compared to bioexposed ones. During the LTE, CD pts had higher rates of IBD-related hospitalizations; most hospitalizations were due to the necessity of surgery. SAEs were observed in a minority of patients and predominantly consisted of infections; the rates of cancer diagnosis are seemingly in line with those of the general population. Overall, our study strengthens the notion that vedolizumab is associated with a long-term real-life durability in terms of both effectiveness and safety.
Disclosure
Daniela Pugliese received speaker fees and/or advisory board from AbbVie, Galapagos, MSD, Takeda and Janssen, Pfizer. Giuseppe Privitera received consultancy fees from Alphasigma and Janssen. Alessandro Armuzzi: consulting and/or advisory board fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mylan, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda; lecture and/or speaker bureau fees from AbbVie, Amgen, Arena, Biogen, Bristol-Myers Squibb, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mitsubishi-Tanabe, Novartis, Pfizer, Roche, Sandoz, Samsung Bioepis, Takeda; and research grants from MSD, Pfizer, Takeda and Biogen.
