scholarly journals P305 Effectiveness and Safety of Vedolizumab in Biologic-Naïve Patients: Real-World Data from the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD)

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S333-S333
Author(s):  
F Macaluso ◽  
W Fries ◽  
S Renna ◽  
A Viola ◽  
M Muscianisi ◽  
...  
Keyword(s):  
Clinical Response ◽  
Real World ◽  
Primary Outcome ◽  
Real World Data ◽  
Mayo Score ◽  
Significant Difference ◽  
Bowel Diseases ◽  
Observational Cohort ◽  
Inflammatory Bowel

Abstract Background Biologic-naïve patients treated with Vedolizumab (VDZ) are largely underrepresented in real-world cohorts. We performed a multicentre, observational, cohort study on the effectiveness and safety of VDZ as treatment for Crohn’s disease (CD) and ulcerative colitis (UC) among biologic-naïve subjects. Methods Data of consecutive biologic-naïve patients with CD and UC treated with VDZ from July 2016 to December 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). The primary outcome was the clinical response at 14 and 52 weeks evaluated with Harvey Bradshaw Index in CD and partial Mayo score in UC. Results 172 consecutive patients (CD: n=88; UC: n=84; median age 66.0 years) were included, with a median follow-up of 58.8 weeks. After 14 weeks, a clinical response was reported in 68.2% of patients with CD and 67.9% of patients with UC treated with VDZ, including 45.5% patients in the CD group and 46.4% patients in the UC group who achieved steroid-free remission. After 52 weeks, a clinical response was reported in 77.4% of CD and in 73.8% of UC patients treated with VDZ, including 59.7% patients in the CD group and 60.7% patients in the UC group who achieved steroid-free remission. All differences between CD and UC were not statistically significant. Cox survival analysis showed no significant difference in the probability of treatment discontinuation between CD and UC patients (log-rank p=0.73). Conclusion This large, real-world, multicenter study demonstrated the effectiveness and safety of VDZ as a first-line biologic, showing high rates of clinical response and steroid-free remission at both induction and maintenance.

scholarly journals P439 Effectiveness of Ustekinumab on Crohn’s disease associated spondyloartropathy: real-world data from the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD)

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S439-S440
Author(s):  
F Macaluso ◽  
W Fries ◽  
A Viola ◽  
G Costantino ◽  
M Muscianisi ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Real World ◽  
Real World Data ◽  
Web Based ◽  
Bowel Diseases ◽  
Concomitant Reduction ◽  
Inflammatory Bowel ◽  
Intestinal Symptoms

Abstract Background The efficacy of Ustekinumab (UST) on Crohn’s disease (CD) associated spondyloarthropathy (SpA) was evaluated neither in randomized controlled trials nor in real-world studies. Web-based data from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD) were extracted to perform a multicentre, real-world assessment of the effectiveness of UST on CD-associated SpA Methods All consecutive CD patients with active SpA at the initiation of the treatment with UST from January 2019 (the date on which the drug became available for clinical practice in Sicily) to August 2019 were extracted from the SN-IBD cohort. The study outcomes were evaluated at 8 and 24 weeks. The primary outcome was the articular response, defined as the disappearance of objective signs of arthritis (swelling and/or articular stiffness) and resolution of pain. As ancillary end-points, the clinical response (reduction of Harvey-Bradshaw Index ≥ 3 compared with baseline with a concomitant reduction of at least ≥ 50% of steroid dosage compared with baseline) and the steroid-free remission (Harvey-Bradshaw Index < 5 without steroids use) were assessed. Results Out of 131 total patients treated with UST, 30 consecutive patients (22.9%) had active SpA at baseline (axial SpA: 3/30; peripheral SpA: 18/30; axial plus peripheral SpA: 9/30). After 8 weeks, 10 patients (33.3%) reported an articular response [0/3 patients with axial SpA, 7/18 patients (38.9%) with peripheral SpA, and 3/9 patients (33.3%) with axial and peripheral SpA]. After 24 weeks, 13 patients (43.3%) had an articular response [0/3 patients with axial SpA, 10/18 patients (55.5%) with peripheral SpA, and 3/9 patients (33.3%) with axial and peripheral SpA]. None of these 13 responders was taking systemic steroids at 24 weeks. The concomitant presence of a clinical response on intestinal symptoms was associated with the articular response at 24 weeks at univariable analysis (OR 5.14, CI 1.09-32.70, p=0.038). Conclusion UST obtained a response on articular symptoms in nearly half of the patients with CD and active SpA at baseline after 24 weeks. The rate of response was higher in case of peripheral arthropathy. The articular response was associated with the clinical response on intestinal symptoms.

scholarly journals P325 Real-World Effectiveness And Safety Of Ustekinumab In Patients With Ulcerative Colitis: A Multi-Centre Study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S349-S350
Author(s):  
D Parakkal ◽  
A Johnson ◽  
M Fenster ◽  
G Ramos ◽  
M Zulqarnain ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Real World ◽  
Drug Level ◽  
Previous Exposure ◽  
Multi Centre Study ◽  
Mayo Score ◽  
Number Of Patients ◽  
Endoscopic Remission

Abstract Background Pivotal trials have shown that ustekinumab (UST) is effective in ulcerative colitis (UC). However, the population included in these trials do not always represent the cohort of patients treated in the “real world”. In this study, we aimed to describe the effectiveness and safety of UST in a clinical cohort of patients with UC Methods We performed a multi-center cohort study and included patients with active UC starting UST. Variables collected included demographics, previous and current UC medications, disease activity (measured using partial and endoscopic Mayo score [PMS and EMS]) at 8 weeks, 6 months and end of follow-up. We also abstracted UST drug level and anti-UST antibodies (AUA), albumin and C-reactive protein levels. Primary outcomes were clinical response at week 8 defined as a reduction of 3 points in the PMS or PMS<2. Secondary outcomes were clinical remission defined as a PMS <2 and endoscopic remission defined as a MES ≤1, and the development of an adverse event (AE) attributed to UST. Results Ninety-five patients were included with a median age of 42 years (IQR:32-57) and 53 (56%) were female. Median follow-up was 5 months (IQR:2.2-7.4). Only 4 (4.3%) were naïve to biologics or tofacitinib and 62 (66%) had previous exposure to at least 2 other biologics. No variables were found to be associated with response at week 8 (Figure 2). Those patients who responded at week 8 had higher median albumin levels vs those who did not (median of 4.4 [IQR: 4.1-4.6] vs 4.1 g/dL [IQR:3.8-4.3]; p=0.02). There were no differences in baseline CRP levels (1mg/dL [IQR:0.6-2.8] vs 0.6 mg/dL [0.3-1.5]; p=0.06). Among the 33 patients who had follow-up endoscopic assessment, 7 (21.2%) had achieved endoscopic remission and 4 (12%) achieved histologic remission. Median UST level was 4.1 mcg/ml (IQR:2.5-5.1) and no patients had detectable AUA. Five patients underwent colectomy (5.3%). Only 6 patients (6.6%) presented with an AE (all minor that included, rash, headaches, arthralgias and infection). Conclusion In a population enriched with refractory UC, UST was well tolerated and induce response and remission in a significant number of patients. The rate of response was lower in obese patients and those with extensive colitis but was not associated with previous exposure to biologics and/or tofacitinib. Larger studies with a longer follow-up are warranted. Figure 1: Rates of clinical response and remission in patients with UC receiving ustekinumab Figure 2: Association between several baseline characteristics and response to ustekinumab in UC

THU0393 INFLAMMATORY BOWEL DISEASES AMONG SECUKINUMAB-TREATED PATIENTS: 24 CASES FROM THE MISSIL REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 431.1-431
Author(s):  
J. G. Letarouilly ◽  
B. Pariente ◽  
D. Staumont-Sallé ◽  
P. Goupille ◽  
P. Claudepierre ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Real World ◽  
Bowel Disease ◽  
Research Support ◽  
Real World Data ◽  
Pooled Data ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
New Onset

Background:An alert regarding about the tolerance of Interleukin 17 (IL-17) inhibitors has been issued from data of randomized controlled trials showing cases of de novo inflammatory bowel diseases (IBD). In a recent analysis of pooled data from 21 clinical trials, cases of IBD events (including Crohn’s disease (CD), ulcerative colitis (UC) and inflammatory bowel disease unclassified (IBDU)) were uncommon (1). Yet, real-world data are lacking.Objectives:To describe real-world data about patients treated by IL-17 inhibitors developing new onset IBD (CD or UC).Methods:A French national registry called MISSIL was started in February 2018 to collect the cases of patients treated by IL-17 inhibitors developing new onset IBD. This registry is conducted by rheumatologist, dermatologist and gastroenterologist learned societies specialized on immune-mediated inflammatory diseases. In France, secukinumab (SEK) has been granted market authorization since June 2016 and ixekizumab since April 2018.Results:24 cases under SEK were reported between February 2018 and January 2020: 3 patients with psoriasis and 21 patients with spondylwoarthritis. There were 20 patients with new onset CD and 4 with UC. Mean age was 51.7 ± 15.7 years old and 12/24 were female; 10 presented an axial spondyloarthritis, 5 a peripheral spondyloarthritis and 6 both,13/17 were HLA-B27 positive,7/19 had a radiographic sacroiliitis and 11/17 a MRI sacroiliitis. Only 2 were biological Disease-modifying antirheumatic drug (bDMARD)-naïve. Crohn’s disease was mainly located at the ileum, colon and rectum. The median time to onset of symptoms was 2 (1-6) months. The main symptoms were diarrhea, nausea and vomiting and loss of weight. Median CRP at the onset of symptoms was 68 mg/L (41-140.5); 21 patients underwent biopsies, 12 were in favor of CD. IL-17 inhibitors were consistently stopped. Patients were treated by corticosteroids (16/24), mesalazine (7/24), methotrexate (3/24), thiopurines (2/24), infliximab (9/243), adalimumab (3/24), golimumab (2/24), ustekinumab (5/24). The evolution was favorable under treatment with complete resolution (4/24), improvement (11/24) or stabilization (5/24). 3 patients worsened under treatment and 1 died (massive myocardial infarction).Conclusion:IBD flare in patients treated with IL-17 inhibitors are rare and lead to discuss the potential iatrogenic role of IL-17 inhibitor drugs. Further cases are needed to better characterize this complication. A case-control study will be conducted to identify patients at risk to develop IBD under IL-17 inhibitor.References:[1]Reich et al. Incidence rates of inflammatory bowel disease in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis treated with secukinumab: a retrospective analysis of pooled data from 21 clinical trials. Ann Rheum Dis. 2019;78:473-479Disclosure of Interests:Jean-Guillaume Letarouilly Grant/research support from: Research grant from Pfizer, Benjamin Pariente: None declared, Delphine Staumont-Sallé Speakers bureau: Lilly, Novartis, Philippe Goupille Grant/research support from: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Consultant of: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Speakers bureau: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Pascal Claudepierre Speakers bureau: Janssen, Novartis, Lilly, Stephane Varin: None declared, Sylvain Lanot: None declared, Emmanuelle Dernis Speakers bureau: Lilly, Novartis, Tristan Pascart Speakers bureau: Novartis, Lilly, Beatrice Banneville Speakers bureau: Lilly, Novartis, Pauline Baudart: None declared, Bruno Gombert: None declared, Elodie BAUER: None declared, Laurianne Plastaras: None declared, Sébastien Barbarot: None declared, Renaud FELTEN: None declared, Loïc Le Dantec: None declared, Nathalie Sultan-Bichat: None declared, Céline Girard: None declared, Arnaud Constantin Grant/research support from: Study was sponsored by Sanofi Genzyme, Consultant of: Consulting fees from Abbvie, BMS, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, Daniel Wendling: None declared, Philippe Gaudin Speakers bureau: Lilly, Denis Jullien Speakers bureau: Lilly, Novartis, Thao Pham Speakers bureau: Novartis, Janssen, Lilly, Rene-Marc Flipo Speakers bureau: Novartis, Janssen, Lilly

scholarly journals Real-world effectiveness of vedolizumab in inflammatory bowel disease: week 52 results from the Swedish prospective multicentre SVEAH study

2021 ◽  
Vol 14 ◽  
pp. 175628482110233
Author(s):  
Carl Eriksson ◽  
Sara Rundquist ◽  
Vyron Lykiardopoulos ◽  
Ruzan Udumyan ◽  
Per Karlén ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Real World ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Real World Data ◽  
Inflammatory Bowel

Background: Prospectively and systematically collected real-world data on vedolizumab are scarce. We aimed to assess the long-term clinical effectiveness of vedolizumab in inflammatory bowel disease (IBD). Methods: This study was a prospective, observational, multicentre study. Overall, 286 patients with active IBD were included (Crohn’s disease, n = 169; ulcerative colitis, n = 117). The primary outcomes were clinical response at week 12 and clinical remission at week 52, based on the Harvey Bradshaw Index and the partial Mayo Clinic score. Secondary outcomes included clinical remission at week 12, clinical response at week 52, corticosteroid-free clinical remission at week 52, changes in biochemical measures, and health-related quality of life (HRQoL). Results: At baseline, 88% of the patients were exposed to anti-TNF and 41% of the patients with Crohn’s disease had undergone ⩾1 surgical resection. At week 12, clinical response was 27% and remission 47% in Crohn’s disease; corresponding figures in ulcerative colitis were 52% and 34%. Clinical response, remission and corticosteroid-free remission at week 52 were 22%, 41% and 40% in Crohn’s disease and 49%, 47% and 46% in ulcerative colitis, respectively. A statistically significant decrease in median faecal-calprotectin and C-reactive protein was observed at 12 and 52 weeks in patients with Crohn’s disease and ulcerative colitis. The HRQoL measures Short Health Scale and EuroQol 5-Dimensions improved in both Crohn’s disease and ulcerative colitis patients ( p < 0.001). Clinical disease activity at baseline was inversely associated with clinical remission at week 52. Conclusion: Vedolizumab proved effective for the treatment of refractory IBD in clinical practice.

scholarly journals P522 Effectiveness of tofacitinib in a real-world Israeli cohort of patients with moderate-severe ulcerative colitis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S498-S499
Author(s):  
I Avni Biron ◽  
A Bar-Gil Shitrit ◽  
B Koslowsky ◽  
U Kopylov ◽  
A Levartovsky ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Real World ◽  
Disease Duration ◽  
Activity Index ◽  
Albumin Level ◽  
Severe Ulcerative Colitis ◽  
Mayo Score ◽  
Observational Cohort ◽  
Retrospective Observational Cohort Study

Abstract Background We sought to define the effectiveness of tofacitinib in a real-world (RW) cohort of patients with moderate to severe ulcerative colitis (UC). Methods This was a multi-center retrospective observational cohort study (2017–2020). Clinical response and remission were defined as a reduction in Simple Clinical Colitis Activity Index (SCCAI) or partial Mayo score (PMS) of ≥3, and SCCAI ≤2 or a PMS ≤1, respectively. Results We included 73 patients (47% male; median age 26 years [IQR 19.5–39.5], disease duration 7 years [IQR 2.5–14.5], follow-up 7.1 months [IQR 3–12]), 91% biologics-experienced, and 74% ≥ 2-biologics. Half of patients used concomitant steroids. Overall, 56.1% discontinued therapy due to either lack of response and/or adverse events (AEs), median time to discontinuation - 9.7 months (IQR 3.4–16). Based on per-protocol analysis, after induction (week-8–16), 33.3% achieved response, 23.3% remission, and 19% corticosteroid free remission. At early maintenance (week 26), 50% achieved response, 26.8% remission, and 24.4% corticosteroid free remission. There were no differences between biologics-experienced and naïve patients. Seventeen patients (23.2%) had an AE: herpes zoster- 2.7%, hospitalization- 12.3%, and colectomy- 2.7%. Remitters had higher albumin level compared with non-remitters (4.2±0.35 Vs. 3.8±0.35, P=0.023, respectively). Conclusion In this multicenter RW cohort of highly biologics - experienced patients with UC, those who continued tofacitinib throughout induction achieved 50% response and 27% remission. Tofacitinib was well-tolerated.

scholarly journals P470 Ustekinumab Trough Levels are not Associated with Clinical Response in Inflammatory Bowel Disease Patients

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S460-S461
Author(s):  
Z Zelinkova ◽  
A Lipovska ◽  
K Otottova ◽  
J Lucenicova ◽  
B Kadleckova
Keyword(s):  
Inflammatory Bowel Disease ◽  
Maintenance Therapy ◽  
Clinical Response ◽  
Dose Escalation ◽  
Real World ◽  
Bowel Disease ◽  
Original Response ◽  
Mayo Score ◽  
Inflammatory Bowel ◽  
Trough Levels

Abstract Background Ustekinumab (UST) has been shown to effectively induce and maintain remission in inflammatory bowel disease (IBD). Only a few studies thus far have focused on UST pharmacokinetics suggesting that both, trough levels after i.v. induction as well as trough levels during stable maintenance might be associated with clinical and endoscopic response to UST. Data from real-world cohorts in this setting are scarce. Therefore, the aim of our study was to assess whether clinical response to UST was associated with a specific pharmacokinetic pattern. Methods All IBD patients treated with UST in one tertiary IBD centre between January 2017 and August 2020 were retrospectively retrieved from the database. Disease activity was assessed by Harvey-Bradshaw index (HBI) and partial Mayo score in Crohn’s disease (CD) and ulcerative colitis (UC) pts; respectively. Clinical response was defined as a decrease of HBI of ≥2 points or partial Mayo score ≥3 points. Patients not responding to therapy by week 16, or loosing original response received dose escalation from 90mg s.c. every 8 weeks to 90mg every 4 weeks. UST through levels were assessed by commercially available ELISA kit (IDKmonitor®) at week 8 after i.v. induction and/or during maintenance therapy after a minimum period of 16 weeks of treatment. Results In total, 61 IBD patients were included (mean age 38 years, range 22–70; 38 women; 54 CD/6 UC/1 IBD-U). All patients were antiTNF experienced, minority (11; 18%) had also been treated with vedolizumab prior UST. Thirty-nine pts (64%) were responders, out of these 15 pts (38%) required dose escalation at some point of the treatment due to secondary loss of response. UST through levels at week 8 were significantly higher than the maintenance levels (mean 5.6±SEM 0.7µg/mL vs. 2.2±0.3µg/mL; p&lt;0.001). There were no significant differences between responders and non-responders neither in trough levels after induction (5±0.8µg/mL vs. 6.4±1.1µg/mL, p=n.s.), nor in trough levels during maintenance therapy (2.3± 0.4µg/mL vs. 1.9 ±0.4µg/mL, p=n.s.). Patients requiring dose escalation did not differ from stable responders in maintenance trough levels (2.4±0,6 µg/mL vs. 2,3 ±0,4 µg/mL). Conclusion In this limited size real-world cohort of IBD patients, we found no difference in pharmacokinetics between reponders and non-reponders to ustekinumab.

scholarly journals Weight Gain and Liver Steatosis in Patients with Inflammatory Bowel Diseases

Nutrients ◽  
2019 ◽  
Vol 11 (2) ◽  
pp. 303 ◽  
Author(s):  
Rocco Spagnuolo ◽  
Tiziana Montalcini ◽  
Daniele De Bonis ◽  
Yvelise Ferro ◽  
Cristina Cosco ◽  
...  
Keyword(s):  
Body Weight ◽  
Weight Gain ◽  
Inflammatory Bowel Diseases ◽  
Weight Change ◽  
Transient Elastography ◽  
Liver Steatosis ◽  
Significant Difference ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Background and Aim: Most studies focused on the benefits of weight loss on hepatic steatosis and no studies have been specifically designed to assess the role of weight gain on the development of liver steatosis in patients affected by inflammatory bowel diseases. The aim of this study was to analyse the relation between weight change over time and liver steatosis in patients with inflammatory bowel diseases. Methods: We retrospectively evaluated a population of 89 ambulatory patients in clinical remission or affected by mild disease, as determined from disease activity indices, with at least one follow-up visit. Transient elastography was used to quantify liver steatosis. Results: A total of 49 individuals (55%) were overweight/obese at baseline. A significant difference in weight change was found between participants that improved, were stable and worsened, over a mean follow-up of four years. (−1.0 kg ± 4; 2.5 kg ± 6; and 5.4 kg ± 5; respectively, p = 0.009). We found a greater probability of worsening in the hepatic fat content in individuals who gained more than 6% of body weight than in those gaining less than this value (log–rank (Mantel–Cox) χ2 test = 9.85; df = 1; p = 0.002). Conclusions: A body weight gain of 6% increases the probability of deterioration in liver steatosis over a period of four years in patients with inflammatory bowel diseases. Weight gain prevention with lifestyle interventions may be the cornerstone treatment of these patients.

scholarly journals P422 Tofacitinib induces clinical and endoscopic remission in biologic refractory ulcerative colitis patients: a real-world Belgian cohort study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S384-S386 ◽  
Author(s):  
A Cremer ◽  
T Lobaton ◽  
S Vieujan ◽  
P Bossuyt ◽  
J F Rahier ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Rectal Bleeding ◽  
Real World ◽  
Stool Frequency ◽  
Janus Kinase ◽  
Short Term ◽  
Mayo Score ◽  
Endoscopic Remission

Abstract Background Tofacitinib, an oral small molecule Janus kinase inhibitor, has been approved in 2018 for the treatment of moderate to severe ulcerative colitis (UC) in Europe. We report on real-world short-term efficacy and safety data from a multicenter Belgium refractory cohort of UC patients with prior exposure to both anti-TNFα and vedolizumab. Methods This is an observational, national, retrospective multicentre study including all UC active patients started on tofacitinib (10 mg BID) from 25 centres in Belgium between November 2018 and August 2019. Prospectively collected data were retrospectively analysed according to intention to treat. Primary endpoints were clinical and endoscopic response and remission rates at weeks 8 and 16. Clinical response and remission were defined as a reduction in the Modified Clinical Mayo score (rectal bleeding, stool frequency) of ≥2 and ≤1, respectively. Endoscopic response and remission were defined as a reduction in Endoscopic Mayo score of ≥1 and ≤1, respectively. Complete endoscopic remission was defined as an Endoscopic Mayo score of 0. Descriptive statistics and Wilcoxon signed-rank test were calculated using Medcal 19.1. Results Demographic and baseline data of the 70 included patients are presented in Table 1. Of note is that nearly all patients were refractory to at least one anti-TNF and vedolizumab. Median follow-up was 16 weeks (IQR 13–26). Fifty-four per cent (38/70) of patients required prolonged induction at 10mg BID. Clinical evaluation was available in all patients at week 8 and 49 patients at week 16, while endoscopic data were available in 52 patients and 42 at weeks 8 and 16, respectively. Clinical response and remission, and endoscopic response and remission at weeks 8 and 16 are presented in Figures 1 and 2. Fifty per cent (21/42) of the patients under steroids at baseline could have stopped steroids at 16 weeks. Median baseline Modified Mayo score (rectal bleeding, stool frequency and endoscopy) decreased from 7 (IQR 5–8) to 4 (IQR 2–7) after 8 weeks (n = 49) (p &lt; 0.0001), and down to 2 (IQR 1–5) at week 16 (n = 40) (p &lt; 0.0001). Median CRP significantly decreased from baseline (5.3 mg/l, IQR [1.9–16.8]) to 1 mg/l at week 8 (IQR 0.5–6.2) (n = 49) (p = 0.003). Tofacitinib was well tolerated with only 1 reported case of single dermatome herpes zoster and no case of venous thromboembolism. Conclusion Tofacitinib very effectively induced short-term clinical and endoscopic response and remission even in a refractory cohort of patients with UC in a real-world clinical setting. During this short-term follow-up, tofacitinib was well tolerated with respect to adverse events.

TNF Inhibitors and Risk of Malignancy in Patients with Inflammatory Bowel Diseases: A Systematic Review

2020 ◽  
Author(s):  
Marie Muller ◽  
Ferdinando D’Amico ◽  
Stefanos Bonovas ◽  
Silvio Danese ◽  
Laurent Peyrin-Biroulet
Keyword(s):  
Real Life ◽  
Skin Cancers ◽  
Increased Risk ◽  
Bowel Diseases ◽  
Risk Of Malignancy ◽  
Observational Cohort ◽  
Inflammatory Bowel ◽  
Digestive Malignancies ◽  
The Impact

Abstract Background and Aims The association between tumour necrosis factor inhibitors [TNFi] and malignancy in patients with inflammatory bowel disease [IBD] is not well understood. Our aim was to systematically evaluate the impact of TNFi use on risk of malignancy in IBD patients in daily clinical practice. Methods We searched Pubmed, Embase and Scopus until March 1, 2020 for observational cohort studies on adult IBD patients reporting malignancy occurrence and TNFi use. Results Twenty-eight studies [20 retrospective and eight prospective] were included, involving 298 717 IBD patients. Mean age at inclusion ranged from 28 to &gt;65 years. Mean follow-up varied from 7 to 80 months. Infliximab was the most frequently used TNFi [13/28 studies, 46.4%], followed by adalimumab [3/28, 10.7%], while both infliximab and adalimumab were evaluated in five studies [17.8%]. In total, 692 malignancies were diagnosed in IBD patients treated with TNFi, accounting for an overall occurrence of 1.0%. The most frequent malignancies were non-melanoma skin cancers [123/692, 17.8%], digestive malignancies [120/692, 17.3%] and haematological malignancies [106/692, 15.3%]. The association between TNFi and malignancy was evaluated in 11 studies [39.3%]: no significant association was found in ten studies, while an increased risk of lymphoma in patients exposed to TNFi was reported in one study. Conclusion TNFi treatment is not associated with an increased risk of malignancy in IBD patients in real-life settings. Further large studies are needed to assess the prognosis of patients exposed to TNFi and risk of recurrence or new cancers in subjects with personal malignancy history.

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