Treatment persistence and colectomy-free outcomes in patients with ulcerative colitis receiving golimumab or adalimumab: a UK experience

ObjectiveTo examine real-world treatment persistence, colectomy-free survival and treatment switching patterns in UK patients with ulcerative colitis (UC) prescribed golimumab or adalimumab.DesignThis was a retrospective chart review study in adult patients diagnosed with UC using data from 16 National Health Service sites in the UK. Patient records were included in the study if they had initiated first or second-line adalimumab or golimumab between 1 March 2016 and 30 September 2017 (index date). Subjects were required for ≥6 months post treatment initiation. Demographics, clinical characteristics, treatment-related data and colectomy data were extracted over a follow-up period of 6–12 months. Treatment persistence rate was the primary outcome. Colectomy-free survival and treatment switching were secondary outcomes. Outcomes were compared between treatments using χ2 tests and Fisher’s exact test for categorical variables. The t-tests were used for continuous variables. Time-to-event variables were evaluated using Kaplan-Meier curves and log-rank tests.ResultsThe study included a total of 183 patients (96 (52.5%) prescribed adalimumab; 87 (47.5%) golimumab), and patients were mostly first line (79.8%). Demographic and clinical characteristics were generally similar between treatment groups. Persistence rates within 12 months were 64.6% for adalimumab and 64.4% for golimumab (p=0.681). Overall, 20.2% switched to other therapy within 1 year, with 8.2% golimumab and 12.0% adalimumab switching to another biologic. Of patients prescribed adalimumab, 14.6% had ≥1 dose change, mainly dose escalations. In the 12 months post treatment initiation, 8.2% of patients underwent colectomy, with no significant difference in colectomy-free survival by treatment, p=0.73.ConclusionThis study provides evidence of clinical outcomes and real-world persistence for adalimumab and golimumab in UC. The persistence rates of both therapies were above 64.0% at 12 months following treatment initiation. In addition, the 1-year colectomy-free survival was relatively similar between the two treatments.

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P433 A real-world observational study assessing treatment persistence in ulcerative colitis patients receiving anti-TNF treatment (golimumab or adalimumab)

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.562 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S394-S394

Author(s):

S Hoque ◽

S Boccaletti ◽

A Puenpatom ◽

C Brown ◽

C Black ◽

...

Keyword(s):

Ulcerative Colitis ◽

Real World ◽

Treatment Initiation ◽

Retrospective Chart Review ◽

Real World Data ◽

Biologic Treatment ◽

Treatment Persistence ◽

Free Survival ◽

The Real ◽

The Uk

Abstract Background There are limited published observational data describing both clinical outcomes and treatment persistence rates for anti-TNFs used to treat ulcerative colitis (UC), particularly for golimumab. Based on published literature the outcomes demonstrated in clinical trials do not necessarily translate into clinical practice, highlighting the importance of real-world studies. In this study, we evaluated treatment persistence, switching patterns, and colectomy outcomes between golimumab and adalimumab in the real-world setting. Methods A retrospective chart review was conducted across 16 NHS sites in the UK. Data describing demographics, treatment history and colectomy were collected for UC patients treated with either golimumab or adalimumab. Patients were receiving golimumab or adalimumab as first or second-line therapy and initiating treatment between 1 March 2016 and 30 September 2017. Patients enrolled were required to have at least 6 months of data for analyses, and were followed within 12 months where the data were available. Kaplan–Meier analysis was conducted to assess time to discontinuation and also time to colectomy; log-rank tests were used to compare the two treatment arms. Results A total of 183 patients, (87 golimumab, 96 adalimumab), mean age was 45.6 years (46.8 years golimumab; 44.4 years adalimumab) and 59.6% were male (71.3% golimumab; 49.0% adalimumab), were included. Overall, 79.8% (78.2% golimumab; 81.3% adalimumab) of patients were receiving their first-line biologic. Treatment persistence with golimumab or adalimumab were relatively similar; 64.4% of golimumab and 64.6% of adalimumab patients remaining on treatment at 12 months (p = 0.7, Figure 1). Of the 65 patients who discontinued treatment within 12 months, 48.4% golimumab and 64.7% adalimumab switched to another biologic. Of those patients who switched, vedolizumab was the most commonly prescribed drug (56.8%), followed by infliximab biosimilar (Inflectra/Remsima) (29.7%) and infliximab (Remicade) (13.5%). Colectomy-free survival was demonstrated by 92.0% golimumab and 91.7% of adalimumab patients 12 months post-treatment initiation (p = 0.7). Conclusion The real-world data collected in this study demonstrate comparable treatment persistence for golimumab compared with adalimumab 12 months following treatment initiation. Colectomy-free survival was relatively similar within 1 year.

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PMO-23 Treatment persistence rates with Tofacitinib in a real-world cohort of anti-TNF refractory ulcerative colitis patients

10.1136/gutjnl-2021-bsg.162 ◽

2021 ◽

Author(s):

Thomas Conley ◽

James Colclough ◽

Eleanor Liu ◽

Violeta Razanskaite ◽

William Jakobek ◽

...

Keyword(s):

Ulcerative Colitis ◽

Real World ◽

Treatment Persistence ◽

Persistence Rates

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Superior treatment persistence with ustekinumab in Crohn’s disease and vedolizumab in ulcerative colitis compared with anti‐TNF biological agents: real‐world registry data from the Persistence Australian National IBD Cohort (PANIC) study

Alimentary Pharmacology & Therapeutics ◽

10.1111/apt.16436 ◽

2021 ◽

Author(s):

Yanna Ko ◽

Sudarshan Paramsothy ◽

Yunki Yau ◽

Rupert W. Leong

Keyword(s):

Ulcerative Colitis ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Real World ◽

Biological Agents ◽

Registry Data ◽

Treatment Persistence

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Comparison of Real-World Treatment Outcomes With Vedolizumab Versus Infliximab in Biologic-Naive Patients With Inflammatory Bowel Disease

Crohn's & Colitis 360 ◽

10.1093/crocol/otz022 ◽

2019 ◽

Vol 1 (2) ◽

Cited By ~ 2

Author(s):

Haridarshan Patel ◽

Dominick Latremouille-Viau ◽

Rebecca Burne ◽

Sherry Shi ◽

Shashi Adsul

Keyword(s):

Inflammatory Bowel Disease ◽

Real World ◽

Bowel Disease ◽

Treatment Initiation ◽

Healthcare Resource ◽

Healthcare Resource Utilization ◽

Persistence Rates ◽

The Us ◽

Inflammatory Bowel

Abstract Background Little is known about long-term real-world effectiveness of vedolizumab versus infliximab in biologic-naive patients with inflammatory bowel disease (IBD). Methods Biologic-naive IBD patients who received vedolizumab or infliximab in the US Explorys Universe database (May 2014–September 2018) were weighted using Entropy-balancing. Results Persistence rates were higher for vedolizumab (N = 542) versus infliximab (N = 1,179) cohort at 12 (84.5% vs 77.5%; P = 0.0061) and 24 (77.6% vs 64.6%; P = 0.0005) months post-maintenance therapy. Healthcare resource utilization composite end point rates were lower in vedolizumab versus infliximab cohort at 12 (36.2% vs 48.2%; P < 0.0001) and 24 (46.9% vs 59.9%; P < 0.0001) months post-treatment initiation. Conclusions Biologic-naive IBD patients who received vedolizumab had better long-term real-world effectiveness measures versus infliximab patients.

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Sa1741 A REAL-WORLD COMPARISON OF THE EFFECTIVENESS AND SAFETY OF VEDOLIZUMAB AND ANTI-TNF THERAPIES IN EARLY TREATMENT INITIATION WITH FIRST-LINE BIOLOGIC THERAPY IN ULCERATIVE COLITIS: RESULTS FROM EVOLVE

Gastroenterology ◽

10.1016/s0016-5085(20)31703-0 ◽

2020 ◽

Vol 158 (6) ◽

pp. S-405

Author(s):

Gerassimos J. Mantzaris ◽

Brian Bressler ◽

Uri Kopylov ◽

Marielle Bassel ◽

Neil R. Brett ◽

...

Keyword(s):

Ulcerative Colitis ◽

Real World ◽

Early Treatment ◽

Treatment Initiation ◽

Biologic Therapy ◽

First Line

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DOP55 A real-world comparison of the effectiveness and safety of vedolizumab and anti-TNF therapies in early treatment initiation with first-line biologic therapy in ulcerative colitis: Results from EVOLVE

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.094 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S092-S094

Author(s):

G Mantzaris ◽

B Bressler ◽

U Kopylov ◽

M Bassel ◽

N Brett ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Response ◽

Real World ◽

Early Treatment ◽

Clinical Remission ◽

Treatment Initiation ◽

Clinical Effectiveness ◽

Mucosal Healing ◽

First Line

Abstract Background Evidence suggests that early treatment (Tx) with biologic agents in Crohn’s disease improves long-term clinical outcomes. However, there is less evidence in ulcerative colitis (UC), and data comparing early Tx with first-line biologic vedolizumab (VDZ) to anti-tumour necrosis factor (anti-TNF) in real-world settings is needed. This study compared the clinical effectiveness and safety of UC patients who initiated VDZ or an anti-TNF as a first-line biologic within 2 years following diagnosis. Methods This was a real-world, multi-country, retrospective chart review study in Canada, Greece and the United States where biologic-naïve UC patients (≥18 years old) were treated with VDZ or an anti-TNF (adalimumab, infliximab, golimumab) agent within 2 years following diagnosis (initiated Tx May 2014–March 2018). Clinical effectiveness and safety data were collected from Tx initiation to earliest of chart abstraction date, death, or 6 months post-Tx discontinuation (Canada only). Tx persistence was defined as the duration of time from treatment initiation to discontinuation. Analyses of cumulative rates of Tx persistence, clinical response, clinical remission and mucosal healing over 24 months were estimated using Kaplan–Meier analyses. Clinical response, remission and mucosal healing were assessed using pre-defined hierarchical algorithms of standard disease measures reported in the medical records. Analyses of incidence rates (per 100 person-years [PYs]) of disease exacerbations, disease-related surgeries, serious adverse events (SAEs) and serious infections (SIs) were performed. Adjusted analyses used inverse probability weighting to balance cohorts. Results This analysis included 176 UC patients (VDZ: 86; anti-TNF: 90) from 37 sites. Mean (SD) age at index date: VDZ, 41.4 (18.9); anti-TNF, 36.8 (15.6) years (p = 0.20) and the proportion male: VDZ, 58.1%; anti-TNF, 56.7% (p = 0.84). At 12 months, 72.9% and 58.1% continued VDZ and anti-TNF respectively (p = 0.03) (Figure 1A). Though there were no differences in clinical response, clinical remission or mucosal healing between VDZ and anti-TNF groups; VDZ patients were significantly less likely to experience disease exacerbations (HR = 0.47 [95% CI: 0.32–0.69]) and SAEs (HR = 0.37 [95% CI: 0.19–0.72]) (Figure 2). Adjusted outcomes (Figures 1C and D, and 2B) were similar to unadjusted outcomes. Conclusion EVOLVE is one of the first studies that compared early VDZ Tx to early anti-TNF Tx in biologic-naïve UC patients. Results showed VDZ was associated with higher persistence, lower likelihood of experiencing disease exacerbations and a more favourable safety profile. Thus, in early UC, Tx with VDZ may improve long-term clinical outcomes. Sample size limitations warrant further study.

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Clinical characteristics and outcomes of patients with advanced hepatocellular carcinoma treated with immunotherapy: A “real world” retrospective study.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e16644 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e16644-e16644

Author(s):

Adel Chergui ◽

Eswar Gadde ◽

Ana Acuna-Villaorduna ◽

Rafi Kabarriti ◽

Sanjay Goel ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Real World ◽

Clinical Characteristics ◽

Treatment Initiation ◽

Local Treatment ◽

Advanced Hepatocellular Carcinoma ◽

Line Treatment ◽

Second Line ◽

Male Predominance ◽

Dismal Prognosis

e16644 Background: Advanced hepatocellular carcinoma (HCC) is an aggressive malignancy with dismal prognosis. Newer agents, including immunotherapy (IO), have been granted accelerated approval for patients previously treated or unable to tolerate sorafenib. However, information outside clinical trials is scarce. This study aims to describe clinical characteristics and outcomes of HCC patients treated with IO. Methods: HCC patients treated with IO were identified using the institutional software, Clinical Looking Glass. Data regarding demographics, clinical and treatment characteristics were collected by chart review. Neutrophil/lymphocyte ratio (NLR) and AFP were collected at IO treatment initiation and considered low if below 4 and 400, respectively. Progression-free survival (PFS) was defined as time from treatment initiation to progression of disease or death, and overall-survival (OS) as time from IO initiation to death from any cause. Disease characteristics were analyzed using descriptive statistics, PFS and OS were plotted using Kaplan-Meier curves. Results: 52 patients with a median age of 64.5 years and male predominance (38, 73.1%) were identified. There were 24 (54.5%) Hispanics, 9 (20.5%) Non-Hispanic Blacks, 7 (15.9%) Non-Hispanic White and 4 (9.1%) Asians. Cirrhosis present in 41 (83.7%), median MELD of 8 (IQ: 7-10). 37 (77.1%) patients had ECOG 0-1. Hepatitis B and C and B infection were encountered in 12 (24.5%) and 22 (44%) patients, respectively. Intravascular invasion present in 16 (34.8%) and extrahepatic metastases in 7 (14.9%). Local treatment was provided to 29 (59.2%) and radiation to 14 (28.6%). First line treatment (tx1) was Sorafenib in 29 (55.8%) and Nivolumab in 21 (40.4%). Nivolumab was second line treatment or beyond (tx2) in 31 (59.6%). Median PFS was 6.2 (3.1-10.6) months and it did not differ between tx1 and tx2 (8 vs 5.9 months, p = 0.90). Median OS was 13.2 months; there was a tendency towards higher survival rates in patients that were treated in tx2 (11.8 vs 14.3 months, 0 = 0.59) and in patients with low NLR (14.8 vs 9.2 months, p = 0.14). Median OS was higher in patients with low AFP at IO treatment initiation (15.7 vs. 9.2 months, p = 0.03). Conclusions: In this multiethnic cohort, the “real world” experience of the benefit of IO in HCC is encouraging, with a median OS exceeding one year. NLR showed potential as a possible biomarker. Expanded data may elucidate the differences if any, between use of IO as front vs. second line therapy, in PFS and OS.

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Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to Lenalidomide and Dexamethasone (LD) for the Treatment of Non-Transplant Eligible Multiple Myeloma

Blood ◽

10.1182/blood.v126.23.1845.1845 ◽

2015 ◽

Vol 126 (23) ◽

pp. 1845-1845 ◽

Cited By ~ 4

Author(s):

Victor H Jimenez-Zepeda ◽

Christopher P. Venner ◽

Andrew Belch ◽

Irwindeep Sandhu ◽

Tatiana Nikitina ◽

...

Keyword(s):

Multiple Myeloma ◽

Overall Survival ◽

Treatment Regimen ◽

Research Funding ◽

Clinical Characteristics ◽

Progression Free Survival ◽

Categorical Variables ◽

P Value ◽

Similar Response ◽

Free Survival

Abstract Introduction: Cyclophosphamide, bortezomib and Dexamethasone (CyBorD) has become the standard frontline approach for the treatment of multiple myeloma (MM) in many centers across Canada. In the non-transplant eligible setting, recently a randomized controlled trial reported on the impact of Lenalidomide and Dexamethasone (LD), showing that this doublet-therapy is a feasible and efficacious combination. Based on the above-mentioned success of the LD combination, we aimed to compare the effect of CyBorD and LD for the treatment of non-transplant eligible MM (NTE) patients in the Alberta Myeloma and Dysproteinemia Program (AMDP). Patients and Methods: The primary objective was to assess ORR and PFS for NTE MM patients treated with CyBorD and LD. The recommended CyBorD regimen was as follows: bortezomib 1.3-1.5 mg/m2 SC or IV days 1, 8, 15 of a 28 day cycle (as of August, 2013 we adopted the a strategy whereby bortezomib can also be given on day 22), cyclophosphamide 300 mg/m2 PO days 1, 8, 15 and 22 and dexamethasone 20-40 mg PO days 1, 8, 15 and 22 with an aim to deliver a minimum of 9 cycles of treatment. LD was given at 25 mg days 1-21 of a 28-day cycle with Dexamethasone 20-40 mg PO days 1, 8, 15 and 22. Dose adjustments were at the discretion of the treating physician. Two-sided Fisher exact test was used to test for differences between categorical variables. A p value of <0.05 was considered significant and survival curves were constructed according to the Kaplan-Meier method and compared using the log rank test. Results: Ninety-one patients have received CyBorD and 56 have received LD. Clinical characteristics are shown in Table 1. At the time of analysis, 64 and 32 patients in the CyBorD and LD are alive of which 10 and 11, respectively, have progressed, ORR and VGPR rates were 85.7% and 56% for patients treated with CyBorD, and 83.9% and 64% for LD respectively (p=0.3). Estimated median OS was 40 months for CyBorD compared to 66 months for LD (p=0.156). In addition, median PFS was longer for LD patients compared to CyBorD (26 months vs 16.4 months, p=0.018). The rate of treatment discontinuation was similar between both groups (8.7% vs 10%, p=0.3). In Conclusion: CyBorD and LD appeared to be effective treatment options for NTE myeloma patients with similar response rates. Recognizing the limitations of a retrospective series, it is interesting to note a longer PFS and a trend towards better PFS in the LD group, however, longer follow-up and prospective validation is still required. Table 1. Clinical Characteristics Characteristic CyBorD, n=91 LD, n=56 P value Age (median) 73.9 73.6 0.2 GenderMaleFemale 57 (62.6%)34 (37.4%) 34 (60.7%)22 (39.3%) 0.8 B2microglobulin (µmol/L) 4.9 4.89 0.4 Albumin (g/L) 35 36 0.7 Stage IStage IIStage III 17.7%35.4%46.9% 23.5%37.2%39.3% 0.6 BMPC (%) 32 37.5 0.6 Heavy chain:IgGIgAFLC onlyIgDIgMBiclonal 501018113 26179010 0.068 Response rateORRCR/nCRVGPRPR 85.7%23%31.8%30.7 83.9%28%37.5%17.8% 0.3 Ab: BMPC: Bone marrow plasma cell Figure 1. Overall Survival according to treatment regimen Figure 1. Overall Survival according to treatment regimen Figure 2. Progression-Free survival according to treatment regimen Figure 2. Progression-Free survival according to treatment regimen Disclosures Jimenez-Zepeda: Celgene: Honoraria; Amgen: Honoraria; J&J: Honoraria. Venner:J&J: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Amgen: Honoraria. Sandhu:Janssen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Amgen: Consultancy, Honoraria. Duggan:Celgene: Honoraria; Jansen: Honoraria. Neri:Celgene: Research Funding. Bahlis:Johnson & Johnson: Speakers Bureau; Johnson & Johnson: Research Funding; Amgen: Consultancy; Johnson & Johnson: Consultancy; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau.

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