Tu1251 Implications of Evolving Anti-Tumour Necrosis Factor (Anti-TNF) Treatment Patterns in a Tertiary Referral Centre: Results of 1457 Patient-Years Follow-up

2012 ◽  
Vol 142 (5) ◽  
pp. S-784-S-785
Author(s):  
Alexandra I. Thompson ◽  
Nicholas A. Kennedy ◽  
Diana Wu ◽  
Elizabeth Hird ◽  
Daniela Stoyanova ◽  
...  
Keyword(s):  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Treatment Patterns ◽  
Referral Centre ◽  
Tertiary Referral ◽  
Tertiary Referral Centre ◽  
Necrosis Factor

scholarly journals POS1021 THE PsABio STUDY IN ITALY: A REAL-WORLD COMPARISON OF THE PERSISTENCE, EFFECTIVENESS AND SAFETY OF USTEKINUMAB AND TUMOUR NECROSIS FACTOR INHIBITORS IN PATIENTS WITH PSORIATIC ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 778-779
Author(s):  
E. Gremese ◽  
F. Ciccia ◽  
C. Selmi ◽  
G. Cuomo ◽  
R. Foti ◽  
...  
Keyword(s):  
Adverse Event ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Research Support ◽  
Treatment Persistence ◽  
Low Disease Activity ◽  
Necrosis Factor

Background:There are still unmet needs in the treatment of psoriatic arthritis (PsA), including in terms of treatment persistence, which is a function of effectiveness, safety and patient satisfaction. Ustekinumab (UST) was the first new biologic drug to be developed for the treatment of PsA after tumour necrosis factor inhibitors (TNFi).Objectives:To compare treatment persistence, effectiveness and safety of UST and TNFi in Italian patients within the PsABio cohort.Methods:PsABio (NCT02627768) is an observational study of 1st/2nd/3rd-line UST or TNFi treatment in PsA in 8 European countries. The current analysis set includes 222 eligible patients treated in 15 Italian centres, followed to Month 12 (±3 months). Treatment persistence/risk of stopping was analysed using Kaplan−Meier (KM) and Cox regression analysis. Proportions of patients reaching minimal disease activity (MDA)/very low disease activity (VLDA) and clinical Disease Activity Index for PsA (cDAPSA) low disease activity (LDA)/remission were analysed using logistic regression, including propensity score (PS) adjustment for imbalanced baseline covariates, and non-response imputation of effectiveness endpoints if treatment was stopped/switched before 1 year. Last observation carried forward data are reported.Results:Of patients starting UST and TNFi, 75/101 (74.3%) and 77/121 (63.6%), respectively, persisted with treatment at 1 year. The observed mean persistence was 410 days for UST and 363 days for TNFi. KM curves and PS-adjusted hazard ratios confirmed significantly higher persistence (hazard ratio [95% confidence interval (CI)]) for UST versus TNFi overall (0.46 [0.26; 0.82]; Figure 1). Persistence was also higher for UST than TNFi in patients receiving monotherapy without methotrexate (0.31 [0.15; 0.63]), in females (0.41 [0.20; 0.83]), and in patients with body mass index (BMI) <25 kg/m2 (0.34 [0.14; 0.87]) or >30 kg/m2 (0.19 [0.06; 0.54]). There was no significant difference in persistence between treatments in patients with BMI 25−30 kg/m2. While patients receiving 1st- and 3rd-line UST or TNFi showed similar risk of discontinuation (0.60 [0.27; 1.29] and 0.36 [0.10; 1.25], respectively), patients receiving 2nd-line UST showed better persistence than those receiving 2nd-line TNFi (0.33 [0.13; 0.87]). Other factors added to the PS-adjusted Cox model did not show significant effects. In patients with available follow-up data, the mean (standard deviation) baseline cDAPSA was 26.3 (15.4) for UST and 23.5 (12.3) for TNFi; at 1-year follow-up, 43.5% of UST- and 43.6% of TNFi-treated patients reached cDAPSA LDA/remission. MDA was reached in 24.2% of UST- and 28.0% of TNFi-treated patients, and VLDA in 12.5% of UST- and 10.2% of TNFi-treated patients. After PS adjustment (stoppers/switchers as non-responders), odds ratios (95% CI) at 1 year did not differ significantly between UST and TNFi groups for reaching cDAPSA LDA/remission (1.08 [0.54; 2.15]), MDA (0.96 [0.45; 2.05]) or VLDA (0.98 [0.35; 2.76]). In total, 23 (20.4%) patients reported ≥1 treatment emergent adverse event with UST and 30 (22.2%) with TNFi; 6 (5.3%) and 10 (7.4%) patients, respectively, discontinued treatment because of an adverse event.Conclusion:In the Italian PsABio cohort, UST had better overall persistence compared with TNFi, as well as in specific subgroups: females, patients on monotherapy without methotrexate, with BMI <25 or >30 kg/m2, and patients receiving UST as 2nd-line treatment. At 1 year, both treatments showed similar effectiveness, as measured by cDAPSA responses and MDA/VLDA achievement.Acknowledgements:This study was funded by Janssen. Contributing author: Prof. Piercarlo Sarzi-Puttini, ASST Fatebenefratelli-Sacco, University of Milan, ItalyDisclosure of Interests:Elisa Gremese: None declared, Francesco Ciccia Speakers bureau: AbbVie, Abiogen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Consultant of: Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Grant/research support from: Celgene, Janssen, Novartis, Pfizer, Roche, Carlo Selmi Speakers bureau: AbbVie, Alfa-Wassermann, Amgen, Biogen, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi-Genzyme, Consultant of: AbbVie, Alfa-Wassermann, Amgen, Biogen, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi-Genzyme, Grant/research support from: AbbVie, Amgen, Janssen, Pfizer, Giovanna CUOMO: None declared, Rosario Foti Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Janssen, Roche, Sanofi, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Janssen, Roche, Sanofi, Marco Matucci Cerinic Speakers bureau: Actelion, Biogen, Janssen, Lilly, Consultant of: Chemomab, Grant/research support from: MSD, Fabrizio Conti Consultant of: AbbVie, Bristol-Myers Squibb, Galapagos, Lilly, Pfizer, Enrico Fusaro Speakers bureau: AbbVie, Amgen, Lilly, Grant/research support from: AbbVie, Pfizer, Giuliana Guggino Speakers bureau: AbbVie, Celgene, Novartis, Pfizer, Sandoz, Grant/research support from: Celgene, Pfizer, Florenzo Iannone Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Andrea Delle Sedie: None declared, Roberto Perricone: None declared, Luca Idolazzi Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, Sandoz, Paolo Moscato: None declared, Elke Theander Employee of: Janssen, Wim Noel Employee of: Janssen, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Silvia Marelli Employee of: Janssen, Laure Gossec Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Biogen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, Grant/research support from: Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, Sanofi, Josef S. Smolen Speakers bureau: AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Lilly, MSD, Novartis- Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, Grant/research support from: AbbVie, AstraZeneca, Lilly, Novartis, Roche.

scholarly journals Discontinuation and switching patterns of tumour necrosis factor inhibitors (TNFis) in TNFi-naive and TNFi-experienced patients with psoriatic arthritis: an observational study from the US-based Corrona registry

RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000880 ◽  
Author(s):  
Philip J Mease ◽  
Chitra Karki ◽  
Mei Liu ◽  
YouFu Li ◽  
Bernice Gershenson ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Patient Demographics ◽  
Switching Patterns ◽  
The Us ◽  
Factor Inhibitor ◽  
The Usa ◽  
Necrosis Factor

ObjectiveTo examine patterns of tumour necrosis factor inhibitor (TNFi) use in TNFi-naive and TNFi-experienced patients with psoriatic arthritis (PsA) in the USA.MethodsAll patients aged ≥18 years with PsA enrolled in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry who initiated a TNFi (index therapy) between March 2013 and January 2017 and had ≥1 follow-up visit were included. Times to and rates of discontinuation/switch of the index TNFi were compared between TNFi-naive and TNFi-experienced cohorts. Patient demographics and disease characteristics at the time of TNFi initiation (baseline) were compared between cohorts and between patients who continued versus discontinued their index TNFi by the first follow-up visit within each cohort.ResultsThis study included 171 TNFi-naive and 147 TNFi-experienced patients (total follow-up, 579.2 person-years). Overall, 75 of 171 TNFi-naive (43.9%) and 80 of 147 TNFi-experienced (54.4%) patients discontinued their index TNFi; 33 of 171 (19.3%) and 48 of 147 (32.7%), respectively, switched to a new biologic. TNFi-experienced patients had a shorter time to discontinuation (median, 20 vs 27 months) and were more likely to discontinue (p=0.03) or switch (p<0.01) compared with TNFi-naive patients. Among those who discontinued, 49 of 75 TNFi-naive (65.3%) and 59 of 80 TNFi-experienced (73.8%) patients discontinued by the first follow-up visit; such patients showed a trend towards higher baseline disease activity compared with those who continued.ConclusionsThe results of this real-world study can help inform treatment decisions when selecting later lines of therapy for patients with PsA.

Influence of Drug Exposure on Vedolizumab-Induced Endoscopic Remission in Anti-Tumour Necrosis Factor [TNF] Naïve and Anti-TNF Exposed IBD Patients

2019 ◽  
Vol 14 (3) ◽  
pp. 332-341 ◽  
Author(s):  
Bram Verstockt ◽  
Evelien Mertens ◽  
Erwin Dreesen ◽  
An Outtier ◽  
Maja Noman ◽  
...  
Keyword(s):  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Drug Exposure ◽  
Real Life ◽  
Predictive Biomarkers ◽  
Treatment Intensification ◽  
Tertiary Referral Centre ◽  
Long Term Treatment ◽  
Endoscopic Remission ◽  
Necrosis Factor

Abstract Background and Objectives Vedolizumab has demonstrated efficacy and safety in patients with Crohn's disease [CD] and ulcerative colitis [UC]. Endoscopic outcome data are limited, especially in anti-tumour necrosis factor [TNF] naïve patients. The present study compared endoscopic outcome in anti-TNF naïve and exposed patients, and explored if this was affected by drug exposure. Methods We retrospectively analysed all patients initiating vedolizumab at our tertiary referral centre since 2015. For UC, endoscopic improvement was defined as a Mayo endoscopic subscore ≤1 at week 14. For CD, endoscopic remission was defined as absence of ulcerations at week 22. Vedolizumab trough concentrations were measured at week 6, week 14 and during maintenance. Results A total of 336 patients were identified [53.3% CD], 20% of them being anti-TNF naïve. Endoscopic improvement was achieved by 56.1% of UC patients and endoscopic remission by 39.1% of CD patients. Endoscopic outcomes were significantly better in anti-TNF naïve vs exposed patients [all: 67.2% vs 42.0%, p = 0.0002; UC: 74.4% vs 50.0%, p = 0.02; CD: 57.1% vs 35.8%, p = 0.03]. Achievement of endoscopic end points significantly impacted long-term treatment continuation [p = 9.7 × 10−13]. A better endoscopic outcome was associated with significantly higher drug exposure in both CD and UC. Conclusions The results of this observational, single-centre real-life study suggest that vedolizumab may induce endoscopic remission in both CD and UC. Although anti-TNF naïve patients had a significantly better outcome, 42% of anti-TNF exposed patients still benefited endoscopically. A clear exposure–endoscopic response relationship exists, but not all patients will benefit from treatment intensification. Hence, predictive biomarkers remain necessary. Podcast This article has an associated podcast which can be accessed at https://academic.oup.com/ecco-jcc/pages/podcast

Patients with rheumatoid arthritis treated with tumour necrosis factor antagonists increase their participation in the workforce: potential for significant long-term indirect cost gains (data from a population-based registry)

2009 ◽  
Vol 69 (01) ◽  
pp. 126-131 ◽  
Author(s):  
J Augustsson ◽  
M Neovius ◽  
C Cullinane-Carli ◽  
S Eksborg ◽  
R F van Vollenhoven
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Indirect Cost ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Population Based ◽  
Hours Worked ◽  
Population Based Registry ◽  
Necrosis Factor

Objective:To investigate the effect of tumour necrosis factor (TNF) antagonist treatment on workforce participation in patients with rheumatoid arthritis (RA).Methods:Data from the Stockholm anti-TNFα follow-up registry (STURE) were used in this observational study. Patients with RA (n = 594) aged 18–55 years, (mean (SD) 40 (9) years) followed for up to 5 years were included with hours worked/week as the main outcome measure. Analyses were performed unadjusted and adjusted for baseline age, disease duration, Health Assessment Questionnaire (HAQ), 28-joint Disease Activity Score (DAS28) and pain score.Results:At baseline patients worked a mean 20 h/week (SD 18). In unadjusted analyses, significant improvements in hours worked/week could already be observed in patients at 6 months (mean, 95% CI) +2.4 h (1.3 to 3.5), with further increases compared to baseline at 1-year (+4.0 h, 2.4 to 5.6) and 2-year follow-up (+6.3 h, 4.2 to 8.4). The trajectory appeared to stabilise at the 3-year (+6.3 h, 3.6 to 8.9), 4-year (+5.3 h, 2.3 to 8.4) and 5-year follow-up (+6.6 h, 3.3 to 10.0). In a mixed piecewise linear regression model, adjusted for age, sex, baseline disease activity, function and pain, an improvement of +4.2 h/week was estimated for the first year followed by an added improvement of +0.5 h/week annually during the years thereafter. Over 5 years of treatment, the expected indirect cost gain corresponded to 40% of the annual anti-TNF drug cost in patients continuing treatment.Conclusion:Data from this population-based registry indicate that biological therapy is associated with increases in workforce participation in a group typically expected to experience progressively deteriorating ability to work. This could result in significant indirect cost benefits to society.

Minimum ten-year follow-up of acetabular fracture fixation from the Irish tertiary referral centre

Injury ◽  
2012 ◽  
Vol 43 (4) ◽  
pp. 500-504 ◽  
Author(s):  
Paul Magill ◽  
James McGarry ◽  
Joseph M. Queally ◽  
Seamus F. Morris ◽  
John P. McElwain
Keyword(s):  
Fracture Fixation ◽  
Acetabular Fracture ◽  
Referral Centre ◽  
Tertiary Referral ◽  
Tertiary Referral Centre

The Prognostic Significance of Monoallelic Versus Biallelic 13q Deletions in Patients with Chronic Lymphocytic Leukemia,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3893-3893
Author(s):  
Smita Sinha ◽  
Timothy W Farren ◽  
Marianne Grantham ◽  
Samir Agrawal
Keyword(s):  
Overall Survival ◽  
Lymphocytic Leukemia ◽  
Referral Centre ◽  
Tertiary Referral ◽  
Interphase Nuclei ◽  
Tertiary Referral Centre ◽  
Cytogenetic Abnormalities ◽  
Significant Difference ◽  
13Q Deletion

Abstract Abstract 3893 Introduction: 13q deletions (13q-) are the commonest cytogenetic abnormality observed in patients with chronic lymphocytic leukemia as detected by fluorescence in situ hybridization (FISH). It has been observed in 45–55% of patients; in 30% it is the sole cytogenetic abnormality and in this context confers a favourable prognosis. However recent studies highlight that the situation may be more complex, with suggestions that the percentage of interphase nuclei with deletions, and the size of the deletion are key determinants of prognosis. Additionally it remains to be established whether the presence of a homozygous versus a heterozygous 13q deletion plays an additional role. Initial reports suggest that heterozygosity does not impact on time to first treatment or overall survival. Methods: We present the results of 247 patients referred to St BartholomewÕs Hospital, a tertiary referral centre, between 2002 and 2010. Diagnostic specimens were sent including cytogenetic analysis, with a proportion also referred for clinical management. Patients referred only for cytogenetic analysis were excluded from the time to treatment (TTT) and survival data. Between August 2002 and December 2010, 247 samples were found to have a 13q deletion. Samples included both peripheral blood and bone marrow. Duplicate patient samples were excluded. The probes used were Abbott Molecular IGH@/CCND1 dual colour dual fusion, Abbott Molecular Vysis LSI p53 / LSI ATM and LSI D13S319 / LSI 13q34 / CEP 12 Multi-color or the Cytocell Aquarius CLL Screening Panel. Results: Interphase FISH detected a monoallelic deletion in 133 patients (53.8%) and biallelic in 32 cases (13%). Mosaics of mono- and biallelic deletions within the nuclei were detected in 32 cases (13%). 50 cases (20.2%) demonstrated 13q deletion in addition to other cytogenetic abnormalities. 145 of the 247 patients were managed clinically at St BartholomewÕs Hospital either as the sole centre or in conjunction with their referring hospital. Seventy-eight of the 145 patients had a monoallelic 13q-, in which 38 cases (48.7%) required therapy, with a median TTT of 70.6 months. 12 patients had a sole biallelic deletion. In contrast, of those patients with a biallelic 13q-, 75% required therapy with a significantly shorter TTT (21.9 months, p=0.0284, figure 1). There were 10 deaths within the monoallelic 13q- cohort with a median follow up time of 31 months. For those with bi13q-, three deaths occurred with a median follow up of 17 months. Nineteen patients had a mosaic of monoallelic and biallelic deletions in their nuclei. Thirteen required treatment with a TTT of 56.6 months, with 3 patient deaths. Median follow up was 42 months. Of the remaining 36 patients with additional cytogenetic abnormalities, 28 (78%) required treatment with a TTT of 24 months, in which 15 patients died (median follow up: 16 months). This group was further characterized; 19 patients had an additional 11q22 deletion, which was the commonest abnormality. Nine patients had an additional 17p13 deletion and six had trisomy 12. The remaining 8 cases were either a combined 17p13- and 11q22- or 11q13-. Conclusion: Two recent studies (171i and 323ii patients) failed to demonstrate a significant difference in TTT and overall survival between patients with a heterozygous and homozygous 13q deletion. In this study, we demonstrated a significant difference in TTT (p=0.0004) amongst the patient subgroups, specifically patients with monoallelic 13q versus biallelic deletions (p=0.0284). Patients with additional cytogenetic abnormalities had the shortest TTT. This group contained patients with 17p deletions that formed 25% of the subgroup. All patient cohorts are currently being characterized further according to age, Rai/Binet stage, CD38 expression, ZAP70 expression, IgH mutational status and percentage of interphase nuclei deleted. As a tertiary referral centre, cases managed at St BartholomewÕs Hospital are skewed towards complex or refractory patients. Whilst patient numbers collated are small, they appear to suggest that a biallelic deletion confers a negative impact on TTT and that 13q deletions may not uniformly represent a good prognostic marker. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Prednisolone-induced diabetes mellitus in the cat: a historical cohort

2020 ◽  
pp. 1098612X2094352
Author(s):  
Sivert Nerhagen ◽  
Hanne L Moberg ◽  
Gudrun S Boge ◽  
Barbara Glanemann
Keyword(s):  
Diabetes Mellitus ◽  
Electronic Records ◽  
High Dose ◽  
Referral Centre ◽  
Tertiary Referral ◽  
Tertiary Referral Centre ◽  
Historical Cohort ◽  
Starting Dose ◽  
Initiation Of Therapy

Objectives Prednisolone is a commonly used drug in cats and potential adverse effects include hyperglycaemia and diabetes mellitus. The aims of this study were to evaluate the frequency and investigate potential predisposing risk factors for the development of prednisolone-induced diabetes mellitus (PIDM) in cats. Methods The electronic records of a tertiary referral centre were searched for cats receiving prednisolone at a starting dose of ⩾1.9 mg/kg/day, for >3 weeks and with follow-up data available for >3 months between January 2007 and July 2019. One hundred and forty-three cats were included in the study. Results Of the 143 cats, 14 cats (9.7%) were diagnosed with PIDM. Twelve out of 14 cats (85.7%) developed diabetes within 3 months of the initiation of therapy. Conclusions and relevance Cats requiring high-dose prednisolone therapy should be closely monitored over the first 3 months of therapy for the development of PIDM.

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