The Application of Commercially Available Mobile Cigarette Topography Devices for E-cigarette Vaping Behavior Measurements

Abstract Introduction The ability to reliably measure real-world vaping behavior is critical to understand exposures to potential toxins. Commercially available mobile topography devices were originally designed to measure cigarette puffing behavior. Information regarding how applicable these devices are to the measurement of electronic cigarette (e-cigarette) vaping topography is needed. Methods Clinical Research Support System (CReSS; Pocket) and Smoking Puff Analyzer Mobile (SPA-M) topography devices were tested against the calibrated laboratory-based smoking puff analyzer duplicator (SPA-D) device combined with an analytical smoking machine that generates programmable puffs with high precision. Puff topography of e-cigarettes was measured over a range of puff volumes (10–130 mL) at 2 and 5 s puff durations (using bell- and square-shaped puffs). “Real-world” topography data collected from 10 participants during 1 week of at-home vaping were also analyzed. Recording anomalies and limitations of the devices, such as accuracy of detection of the puff end, flow rate dropouts, unreported puffs, and abandoned vaping sessions for the CReSS, and multi-peak puffs for the SPA-M were defined. Results The accuracy of puff volumes and durations was determined for both devices. The error for SPA-M was generally within ±10%, whereas that for the CReSS varied more widely. The CReSS consistently underestimated puff duration at higher flow rates. Conclusions CReSS and SPA-M topography devices can be used for real-world e-cigarette topography measurements, but researchers have to be aware of the limitations. Both devices can provide accurate measurements only under certain puff parameter ranges. The SPA-M provided more accurate measurements under a wider range of puffing parameters than the CReSS. Summary data reported by both devices require thorough analysis of the raw data to avoid misleading data interpretation. Implications Results of this study provide researchers with valuable information about the capability of commercially available cigarette topography devices to measure real-world vaping behaviors. The differing measurement ranges of the two devices and puff recording limitations and anomalies should be taken into account during analysis and interpretation of real-world data.

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FRI0362 COMPARATIVE EFFECTIVENESS OF USTEKINUMAB (UST) AND TNF INHIBITORS (TNFI) IN PATIENTS WITH PSORIATIC ARTHRITIS (PSA) IN THE REAL-WORLD, MULTINATIONAL PSABIO STUDY: 12-MONTH FOLLOW-UP

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2755 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 778-779

Author(s):

J. S. Smolen ◽

S. Siebert ◽

T. Korotaeva ◽

P. Bergmans ◽

K. De Vlam ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Real World ◽

Activity Index ◽

Treatment Options ◽

Disease Activity Index ◽

Rapid Screening ◽

Research Support ◽

Real World Data

Background:Among treatment options for PsA, IL-12/23 inhibition with UST was the first new biologic mode of action after TNFi. Few real-world data comparing UST with TNFi are available.Objectives:Comparison of UST and TNFi treatment effectiveness within the prospectively followed PsABio cohort at 12-month (mo) follow-up.Methods:The PsABio study (NCT02627768) evaluates effectiveness, tolerability and persistence of 1st, 2nd or 3rd-line UST or TNFi in PsA. Proportions of patients (pts) reaching MDA/very low disease activity (VLDA) and clinical Disease Activity index for PSoriatic Arthritis (cDAPSA) LDA/remission are described. Comparison across UST and TNFi cohorts was done on last observation carried forward up to 12 (±3) mo, with non-response imputation for pts who had stopped/switched initial treatment. Logistic regression analysis was used, including propensity score (PS) analysis to adjust for imbalanced prognostic baseline (BL) covariates: country, age, sex, BMI, smoking (yes/no), comorbidities (cardiovascular/metabolic syndrome), PsA type (axial, polyarticular, oligoarticular), psoriasis body surface area (BSA), disease duration, cDAPSA, 12-item PsA Impact of Disease (PsAID-12), dactylitis, enthesitis, Fibromyalgia Rapid Screening Tool (FiRST) score, line of biologic (b)DMARD, synthetic DMARD use, and steroid or NSAID use.Results:Of 929 eligible pts, 893 had evaluable data at BL and at follow-up; 438 (95.6%) were treated with UST and 455 (96.6%) with TNFi (including stoppers/switchers). UST and TNFi groups had BL differences in mean age (51.0 vs 48.5 years, respectively), concurrent comorbidities (68.7% vs 60.9%), time since diagnosis (7.5 vs 6.2 years), line of treatment (1st-line 45.0% vs 55.2%; 3rd-line 20.5% vs 12.1%), NSAID use (54.8% vs 68.8%), concomitant MTX use (29.9% vs 42.0%) and psoriasis skin involvement (BSA >10% in 26.6% vs 14.8%).In 714 pts with available data, mean (standard deviation) BL cDAPSA was 30.6 (20.2; n=358) for UST and 29.3 (18.6; n=356) for TNFi. Observed data showed differences in proportion of pts achieving MDA/VLDA and cDAPSA LDA/remission in favour of TNFi, but after PS adjustment for BL differences (such as line of therapy, skin psoriasis, concomitant conventional DMARD, etc.), odds ratios for reaching targets at 12 mo did not significantly differ between UST and TNFi groups (Fig. 1).Comparison of 6- and 12-mo unadjusted data showed sustained MDA/VLDA responses with both UST (21.8%) and TNFi (29.5%), with comparable proportions of additional pts achieving these targets between 6 and 12 mo (17.0% and 20.3%, respectively). Sustained efficacy became lower with successive lines of treatment (data not shown).Conclusion:Various factors, including patient characteristics such as comorbidities, influence the physician’s selection of treatment modality for patients needing a bDMARD. Our real-world results demonstrate differences in observed clinical effectiveness between UST and TNFi. However, after PS adjustment for a number of BL differences, clinical results at 12 mo were comparable between UST and TNFi groups. Data at 12 mo also show sustained response with both UST and TNFi treatment, as well as a similar rate of pts achieving targets after 6 to 12 mo of treatment.Acknowledgments:This study was funded by Janssen.Disclosure of Interests:Josef S. Smolen Grant/research support from: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Consultant of: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Stefan Siebert Grant/research support from: BMS, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Elisa Gremese Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Wim Noel Employee of: Janssen Pharmaceuticals NV, Michael T Nurmohamed Grant/research support from: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Consultant of: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Elke Theander Employee of: Janssen-Cilag Sweden AB, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB

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O24 Concomitant treatment with MTX does not increase the efficacy of ustekinumab or TFNi in PsA: results from the PsABio study

Rheumatology ◽

10.1093/rheumatology/keaa110.023 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

Stefan Siebert ◽

Elisa Gremese ◽

Paul Bergmans ◽

Kurt de Vlam ◽

Beatriz Joven-Ibáñez ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Real World ◽

Concomitant Treatment ◽

Skin Involvement ◽

Research Support ◽

Real World Data ◽

Low Disease Activity ◽

Intention To Treat ◽

Patient Reported

Abstract Background The additional benefit of methotrexate (MTX) as a concomitant treatment in PsA has not been fully elucidated for TNF inhibitors (TNFi) and no real-world data on this currently exist for ustekinumab (UST). We investigated the additive effect of MTX on the ability to reach composite treatment targets beyond monotherapy with UST or TNFi, and the ability to improve patient-reported outcomes in a real-world clinical setting in 8 European countries. Methods The PsABio study (NCT02627768) evaluates persistence, effectiveness and tolerability of 1st, 2nd or 3rd-line UST or TNFi in patients with PsA. Proportions of patients reaching minimal disease activity (MDA)/very low disease activity (VLDA) and clinical Disease Activity in Psoriatic Arthritis (cDAPSA) low disease activity (LDA) or remission, as well as the patient acceptable symptom state (PASS; score ≤4) of the 12-item Psoriatic Arthritis Impact of Disease questionnaire (PsAID-12) were evaluated. Here we present 6-month follow-up data using intention to treat (ITT) analysis; patients who stopped/switched initial treatment were imputed as non-responders. The effect of MTX co-therapy was investigated within UST and TNFi cohorts, as well as between the cohorts, using multivariate logistic regression including interaction terms, and propensity score (PS) analysis to adjust for imbalanced, potentially prognostic, baseline covariates. Results Of 930 patients, data was available for 868 ITT patients, including patients who switched/stopped before 6 months (UST: n = 28/426 [6.6%], TNFi: n = 44/442 [10.0%]). At baseline there were no relevant differences in demographics and disease activity, however there were significant differences in skin involvement as well as csDMARD and NSAID exposure. Co-therapy with MTX did not increase the likelihood of achieving any of the outcomes in either the UST or TNFi cohorts (Table 1). After PS adjustment, co-treatment with MTX did not influence treatment effects differently when added to UST compared with TNFi. concomitant use of csDMARDs other than MTX yielded very similar results. Conclusion In a real-world setting, concomitant treatment with MTX in addition to UST or TNFi was not associated with enhanced effects across a broad variety of disease outcomes, including disease activity, disease impact, and skin involvement within or between treatment cohorts, after PS adjustment for baseline confounders. Disclosures S. Siebert: Consultancies; AbbVie, UCB, Pfizer, Janssen, Boehringer Ingelheim, Celgene, Novartis. Grants/research support; Pfizer, Janssen, BMS, Celgene, UCB, Boehringer Ingelheim. E. Gremese: Consultancies; AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Sanofi, UCB, Roche, Pfizer. P. Bergmans: Shareholder/stock ownership; Johnson & Johnson. Other; Employee of Janssen. K. de Vlam: Consultancies; Johnson & Johnson. B. Joven-Ibáñez: Member of speakers’ bureau; Celgene, Novartis, MSD, Pfizer, AbbVie, Janssen. G. Katsifis: None. T.V. Korotaeva: Consultancies; Pfizer, MSD, Novartis, AbbVie, Celgene, Biocad, Janssen, UCB, Lilly, Novartis-Sandoz. W. Noël: Other; Employee of Janssen. C. Selmi: None. P.P. Sfikakis: None. P. Smirnov: Other; Employee of Janssen. E. Theander: Other; Employee of Janssen. M.T. Nurmohamed: Grants/research support; Pfizer, AbbVie, Roche, BMS, MSD, Mundipharma, UCB, Janssen, Menarini, Lilly, Sanofi, Celgene. L. Gossec: Honoraria; AbbVie, Celgene, Janssen, Lilly, Novartis-Sandoz, Pfizer, Sanofi, UCB. Grants/research support; Pfizer. J.S. Smolen: Consultancies; AbbVie, Amgen, AstraZeneca, Astro, Celgene, Celtrion, GlaxoSmithKline, ILTOO Pharma, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB. Grants/research support; AbbVie, Janssen, Lilly, MSD, Pfizer, Roche.

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Peak Inspiratory Flow Rate in COPD: An Analysis of Clinical Trial and Real-World Data

International Journal of Chronic Obstructive Pulmonary Disease ◽

10.2147/copd.s291554 ◽

2021 ◽

Vol Volume 16 ◽

pp. 933-943

Author(s):

Martin Anderson ◽

Kathryn Collison ◽

M Bradley Drummond ◽

Melanie Hamilton ◽

Renu Jain ◽

...

Keyword(s):

Clinical Trial ◽

Flow Rate ◽

Real World ◽

Inspiratory Flow ◽

Inspiratory Flow Rate ◽

Real World Data ◽

World Data ◽

Peak Inspiratory Flow ◽

Peak Inspiratory Flow Rate

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

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2516 ◽

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

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FRI0289 DOES SMOKING AFFECT SECUKINUMAB TREATMENT OUTCOMES AND SAFETY IN PATIENTS WITH ANKYLOSING SPONDYLITIS? – REAL WORLD DATA FROM THE GERMAN AQUILA STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.256 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 733.1-733

Author(s):

E. Riechers ◽

U. Kiltz ◽

J. Brandt-Juergens ◽

P. Kästner ◽

D. Peterlik ◽

...

Keyword(s):

Ankylosing Spondylitis ◽

Disease Activity ◽

Real World ◽

Smoking Status ◽

Interventional Study ◽

Research Support ◽

Real World Data ◽

Global Functioning ◽

Mean Values ◽

World Data

Background:There is growing body of evidence that smoking is associated with more active and severe disease in patients (pts) with ankylosing spondylitis (AS).1,2The German non-interventional study AQUILA provides real-world data on the influence of smoking on therapeutic effectiveness and safety under secukinumab (SEC), a fully human monoclonal antibody that selectively inhibits interleukin-17A.Objectives:The aim of this interim analysis is to describe selected baseline (BL) demographics, to evaluate SEC effectiveness on disease activity and global functioning and health, and to report safety profile depending on smoking status of AS pts.Methods:AQUILA is an ongoing, multi-center, non-interventional study including up to 2700 pts with active AS or psoriatic arthritis. Pts were observed from BL up to week (w) 52. Real-world data was assessed prospectively and analyzed as observed. Assessment of CRP and validated questionnaires were used to collect data on disease activity (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI), global functioning and health (Assessment of SpondyloArthritis-Health Index, ASAS-HI) and depressive mood (Beck´s Depression Inventory version II, BDI-II). For calculation of proportion of pts who experienced (serious) adverse events ((S)AEs), all AS pts were included who received at least one dose of SEC irrespective of further documentation of any study visit. This analysis focuses on the subgroups non-smoker (NS) and smoker (S).Results:At BL, 311 AS pts were included: 42.1% (n=131) NS and 32.8% (n=102) S. Remaining subgroups were 15.1% (n=47) ex-smoker and 10.0% (n=31) of unknown smoking status. About half of AS pts in NS were male, while in S (69.6%) portion of men was more than twice as high as of women. S were slightly younger than NS (mean age: 43.9/49.0 years). During the study, CRP value decreased irrespective of smoking status with numerically higher fluctuations in S (Fig. 1A). BASDAI (NS: 5.2 at BL to 3.7 at w52, S: 5.6 at BL to 4.1 at w52) and ASAS-HI (Fig. 1B) scores numerically improved best in NS, whereas more variations were seen in S; the same was observed for BDI-II score values (NS: 11.8 at BL to 9.2 at w52, S: 13.0 at BL to 12.1 at w52). Although no major significant differences in mean values existed between NS and S, S displayed – except in w4 – overall higher mean values in the parameters mentioned above. Regarding the occurrence of AEs/SAEs with or without suspected relationship to SEC, there was no significant difference between NS and S (Table 1).Table 1.Overview of AEs (and SAEs) under SEC treatment depending on smoking status in AS ptsNumber of pts withNS (N=140), n (%)S (N=110),n (%)P valueAE95 (67.9)78 (70.9)0.80AE with suspected relationship to SEC66 (47.1)41 (37.3)0.29SAE39 (27.9)30 (27.3)0.95SAE with suspected relationship to SEC15 (10.7)10 (9.1)0.87Conclusion:In a real-world setting, SEC improved disease activity and global functioning and health in AS pts with slight (mostly non-significant) differences between NS and S. Overall, this interim analysis shows that SEC is an effective treatment with a favorable safety profile up to 52 weeks, irrespective of the pts’ smoking status. Further progress of the AQUILA study will reveal whether this trend will continue.Figure 1.CRP and global functioning and health in AS pts treated with SEC depending on smoking status**CRP data/ASAS-HI scores were documented not for all AS pts at BL and subsequent visits.References:[1]Averns HL et al, Scand J Rheumatol 1996;25:138-42; 2. Chung HY et al, Ann Rheum Dis 2012;71:809-16Disclosure of Interests:Elke Riechers Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Chugai, Novartis, UCB, Uta Kiltz Grant/research support from: AbbVie, Amgen, Biogen, Novartis, Pfizer, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, Jan Brandt-Juergens: None declared, Peter Kästner Consultant of: Chugai, Novartis, Daniel Peterlik Employee of: Novartis Pharma GmbH, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi

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AB0817 DOES SMOKING AFFECT SECUKINUMAB TREATMENT OUTCOMES AND SAFETY IN PATIENTS WITH PSORIATIC ARTHRITIS? - REAL WORLD DATA FROM THE GERMAN AQUILA STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.365 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1711.1-1711

Author(s):

E. Riechers ◽

U. Kiltz ◽

J. Brandt-Juergens ◽

P. Kästner ◽

D. Peterlik ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Real World ◽

Interim Analysis ◽

Smoking Status ◽

Depressive Mood ◽

Research Support ◽

Real World Data ◽

World Data ◽

Number Of Patients

Background:Several studies have shown a negative association between smoking status and psoriatic arthritis (PsA) clinical outcomes.1,2The German non-interventional study AQUILA provides real-world data on the influence of smoking on therapeutic effectiveness and safety issues under secukinumab (SEC), a fully human monoclonal antibody that selectively inhibits interleukin-17A.Objectives:The aim of this interim analysis is to describe selected baseline (BL) demographics, to evaluate SEC effectiveness on disease activity and depressive mood and to report the safety profile depending on smoking status of PsA patients.Methods:AQUILA is an ongoing, multi-center study including up to 2700 patients with active PsA or ankylosing spondylitis. Patients were observed from BL up to week (w) 52. Real-world data was assessed prospectively and analyzed as observed. In addition to the assessment of C-reactive protein (CRP), data was collected on patient´s disease activity (tender/swollen joint counts, TJC/SJC), skin disease activity (Psoriasis Area and Severity Index, PASI) and depressive mood (Beck´s Depression Inventory version II, BDI-II). For calculation of the proportion of patients who experienced (serious) adverse events ((S)AEs), all PsA patients were included who received at least one dose of SEC irrespective of further documentation of any study visit. This interim analysis focuses on subgroups non-smoker (NS) and smoker (S).Results:At BL, 641 PsA patients were included: 49.8% (n=319) non-smokers (NS) and 24.3% (n=156) smokers (S). 17.5% (n=112) were ex-smoker and 8.4% (n=54) of unknown smoking status. In both, NS and S, the proportion of women was higher (58.0% in NS and 67.3% in S). NS were slightly older than S (mean age: 53.8/49.7 years). There were no significant differences between NS and S in mean CRP within the 52 weeks (Fig. 1A). Both TJC and SJC improved over time and were similar between NS and S (Fig. 1B). Although mean absolute PASI value was worse in S at BL, a similar temporal improvement was seen in both groups (NS: 7.0 at BL to 1.0 at w52; S: 9.2 at BL to 1.0 at w52). BDI-II scores decreased in both groups with overall higher values in S (NS: 10.9 at BL to 9.1 at w52; S: 12.8 at BL and 10.8 at w52). Regarding the occurrence of AEs and SAEs with or without suspected relationship to SEC, NS had percentagewise less events than S (Table 1). In addition, percentage of PsA patients who discontinued SEC treatment due to an AE was lower for NS compared to S.Table 1.Overview of AEs (and SAEs) under SEC treatment depending on smoking status in PsA patientsNumber of patients withNS (N=333), n (%)S (N=161),n (%)P valueAE233 (70.0)118 (73.3)0.11AE with suspected relationship to SEC129 (38.7)72 (44.7)0.10SAE74 (22.2)45 (28.0)0.06SAE with suspected relationship to SEC29 (8.7)18 (11.2)0.37Figure 1.Disease activity in PsA patients treated with SEC depending on the smoking status**CRP data/ACR joint counts were documented not for all PsA patients at BL and subsequent visits.Conclusion:In a real-world setting, SEC improved disease activity and depressive mood of PsA patients with no obvious differences between NS and S. Overall, this interim analysis shows that SEC is an effective and reliable treatment, irrespective of the PsA patients’ smoking status. Further progress of the AQUILA study as well as long-term data from other real-world observational studies with SEC, such as SERENA, will reveal whether this trend will continue.References:[1]Hojgaard P et al, Ann Rheum Dis 2015; 74:2130-6; 2. Eder L et al, Arthritis Care Res 2011 Aug; 63:1091-7Disclosure of Interests:Elke Riechers Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Chugai, Novartis, UCB, Uta Kiltz Grant/research support from: AbbVie, Amgen, Biogen, Novartis, Pfizer, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, Jan Brandt-Juergens: None declared, Peter Kästner Consultant of: Chugai, Novartis, Daniel Peterlik Employee of: Novartis Pharma GmbH, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi

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POS0445 PHYSICIAN AND PATIENT REPORTED EFFECTIVENESS OUTCOMES ARE SIMILAR IN TOFACITINIB AND TNF INHIBITORS IN RHEUMATOID ARTHRITIS PATIENTS: DATA FROM A RHEUMATOID ARTHRITIS REGISTRY IN CANADA

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.787 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 452.1-452

Author(s):

M. Movahedi ◽

A. Cesta ◽

X. Li ◽

E. Keystone ◽

C. Bombardier

Keyword(s):

Rheumatoid Arthritis ◽

Real World ◽

Treatment Initiation ◽

Activity Index ◽

Disease Activity Index ◽

Research Support ◽

Real World Data ◽

Treatment Groups ◽

Patient Reported ◽

Anxiety Depression

Background:Tofacitinib (TOFA) is an oral, small molecule drug used for rheumatoid arthritis (RA) treatment as an alternative option to biologic disease modifying antirheumatic drugs (bDMARDs) including tumor necrosis factor inhibitors (TNFi).Objectives:We aimed to evaluate physician and patient reported effectivness outcomes in TNFi compared to TOFA, using real-world data from the Ontario Best Practices Research Initiative (OBRI).Methods:RA patients enrolled in the OBRI initiating their TOFA or TNFi (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab, and Biosimilars) between 1st June 2014 (TOFA approval date in Canada) and 31st Dec 2019 were included. Patients were required to have physician and patient reported effectivness outcomes data available at treatment initiation and 6-month (± 2 months) follow-up. These included clinical disease activity index (CDAI), rheumatoid arthritis disease activity index (RADAI), HAQ-DI, sleep problem, and anxiety/depression scores. Multiple imputation (Imputation Chained Equation, N=20) was used to deal with missing data for covaraites at treatment initiation. To deal with confounding by indication, we estimated propensity scores for covariates with an absolute standard difference greater than 0.1 between the two treatment groups.Results:A total of 419 patients were included. Of those, 226 were initiating a TNFi and 193 TOFA, and had a mean (SD) disease duration of 8.0 (8.7) and 12.6 (9.6) years, respectively. In the TNFi group, 81.9% were female and mean age (SD) at treatment initiation was 56.6 (13.4) years. In the TOFA group, 85% were female and mean (SD) age at treatment initiation was 60.3 (11.2) years. The TNFi group was less likely to have prior biologic use (21.7%) compared to the TOFA group (67.9%). At treatment initiation, physical function measured by HAQ-DI was significantly lower in TNFi compared to the TOFA group (1.2 vs.1.4).The rate of CDAI LDA/remission at 6 months was 36.7% and 33.2% in TNFi and TOFA group, respectively. The generalized linear mixed models (GLMM) adjusting for propensity score quantile, showed that there was no significant difference in CDAI LDA/remission (ORs: 0.85, 95% CI: 0.51, 1.43), RADAI (coefficient: 0.48, 95% CI: -0.18, 1.14), HAQ-DI (coefficient: -0.01, 95% CI: -0.18, 0.16), sleep problems (coefficient: -0.25, 95% CI: -0.95, 0.45), and anxiety/depression scores (coefficient: 0.12, 95% CI: -0.35, 0.58) between the two treatment groups (TOFA used as reference).Conclusion:In this real-world data study, we found that, physician and patient reported effectivness outcomes are similar in the TNFi and TOFA groups 6 months after treatment initiation in patients with RA.Disclosure of Interests:Mohammad Movahedi: None declared, Angela Cesta: None declared, Xiuying Li: None declared, Edward Keystone Grant/research support from: Amgen, Merck, Pfizer Pharmaceuticals, PuraPharm. Speaker Honoraria Agreements: AbbVie, Amgen, Bristol-Myers Squibb Company, Celltrion, Myriad Autoimmune, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, Sanofi-Genzyme, Samsung Bioepsis. Consulting Agreements/Advisory Board Membership: AbbVie, Amgen, Bristol-Myers Squibb Company, Celltrion, Myriad Autoimmune, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, Sanofi-Genzyme, Samsung Bioepsis, Claire Bombardier Grant/research support from: OBRI was funded by peer reviewed grants from CIHR (Canadian Institute for Health Research), Ontario Ministry of Health and Long-Term Care (MOHLTC), Canadian Arthritis Network (CAN) and unrestricted grants from: Abbvie, Amgen, Aurora, Bristol-Meyers Squibb, Celgene, Hospira, Janssen, Lilly, Medexus, Merck, Novartis, Pfizer, Roche, Sanofi, & UCB. Dr. Bombardier held a Canada Research Chair in Knowledge Transfer for Musculoskeletal Care and a Pfizer Research Chair in Rheumatology

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Looking in the medicine cabinet: methods for using real-world data to assess the impact of measles, mumps and rubella (MMR) and recombinant adjuvanted varicella-zoster vaccines on coronavirus disease 2019 (COVID-19) prevention and case fatality

Gates Open Research ◽

10.12688/gatesopenres.13329.1 ◽

2021 ◽

Vol 5 ◽

pp. 115

Author(s):

Douglas McNair ◽

Hao Hu ◽

Casey Selwyn

Keyword(s):

Real World ◽

Case Fatality ◽

Data Interpretation ◽

The United States ◽

Zoster Vaccine ◽

Real World Data ◽

World Data ◽

Varicella Zoster ◽

Viral Vaccines ◽

The Impact

Background: Analysis of real-world data can be used to identify promising leads and dead ends among products being repurposed for clinical practice for coronavirus disease 2019 (COVID-19). This paper uses real-world data from Cerner Labs collected from 90 source institutions in the United States to assess the potential impact of live viral vaccines on COVID-19 case fatality rates. Methods: We identified 373,032 polymerase chase reaction (PCR)-positive COVID-19 cases in the Cerner Labs database between 01-MAR-2020 and 31-DEC-2020 and identified patients that had received measles, mumps and rubella (MMR) or a recombinant adjuvanted varicella-zoster vaccine within the previous 5 years. We calculated heterogeneity scores to support interpretation of results across institutions, and used stepwise forward variable selection to construct covariable-based propensity scores. These scores were used to match cases and control for biasing and confounding issues inherent in observational data. Results: Neither the recombinant adjuvanted varicella-zoster vaccine nor MMR showed significant efficacy in prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We could not derive clinically significant results on the impact of MMR for case fatality rates due to persistently high rates of heterogeneity between institutions. However, we were able to achieve acceptable levels of heterogeneity for the analysis of the recombinant adjuvanted varicella-zoster vaccine, and found a clinically meaningful benefit of reduced case fatality rate, with an odds ratio of 0.43 (95% confidence interval [CI]: 0.38 – 0.48). Conclusions: Using propensity score matching and heterogeneity statistics can help guide our interpretation of real-world data, and rigorous statistical methods are needed to reduce bias or disparities in data interpretation. Applying these methods to the impact of live viral vaccines on COVID-19 case fatalities yields actionable findings for further analysis.

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FRI0348 PERSISTENCE OF SECUKINUMAB AND USTEKINUMAB IN PSORIATIC ARTHRITIS: A REAL-WORLD MULTICENTRIC COHORT OF 409 PATIENTS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.746 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 769.2-769

Author(s):

J. G. Letarouilly ◽

B. Flachaire ◽

C. Labadie ◽

N. Cohen ◽

M. Kyheng ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Propensity Score ◽

Real World ◽

Subgroup Analysis ◽

Cox Model ◽

Sensitivity Analyses ◽

Research Support ◽

Real World Data ◽

Persistence Rate

Background:Real-world data are missing for Ustekinumab (UST) and secukinumab (SEK) in psoriatic arthritis (PsA).Objectives:To evaluate the characteristics of the patients (pts) with PsA treated by UST or SEK and to assess real world persistence of UST and SEK in PsA.Methods:This is a retrospective, multicenter study of pts with PsA (CASPAR criteria or diagnosis confirmed by a rheumatologist) initiating UST or SEK with a follow-up ≥ 6 months from January 2011 to April 2019. The comparison of persistence between UST and SEK was analysed using a Cox model with an inverse probability of treatment weighting propensity score including 11 confounding factors. Subgroup analyses (age>65 years, gender, Body Mass Index (BMI), Charlson score>2, psoriasis, CRP>5mg/L, number (nb) of prior biotherapies, proportion of pts on maximum dose of UST or SEK, combination with methotrexate (MTX), enthesitic and axial forms of PsA) were also performed to test the heterogeneity of UST and SEK persistence. Finally, 2 sensitivity analyses were performed, first excluding the pts treated before the marketing authorization of SEK, and then excluding the pts that underwent a molecule switch. Causes of discontinuation were also collected.Results:406 pts were included: 245 with UST and 161 with SEK. At baseline before propensity score-matching, the UST group has a higher BMI (28.9 ± 6.4 kg/m2vs. 27.4 ± 6.0 kg/m2), more peripheral forms (98% vs. 90.8%), a higher nb of active smokers (27.1% vs. 19.9%), a higher frequency of psoriasis (96.3% vs. 83.2%), less MTX users (38.9% vs. 44.2%), a higher nb of pts with CRP >5mg/L (54.3% vs. 47%), a higher nb of pts naïve to biotherapies (22% vs. 13%) and a higher nb of pts with recommended dosing (97.3% vs 50.9%). The median persistence was 9.4 months and 14.7 months for UST and SEK, respectively. The persistence rate was lower in the UST group compared to the SEK group (40.9% vs. 59.1% % at 1 year; 26.4% vs. 38.0% at 2 years; weighted HR=1.42; 95% CI 1.07 to 1.92; p=0.015) (Fig 1). In subgroup analysis, combination with MTX was associated with a higher persistence rate in the patients with SEK compared to those receiving UST: 43.6% vs. 23.2% (HR=2.20; 95% CI 1.30 to 3.51; p=0.001), whereas no difference was observed in SEK and UST monotherapy: 33.8% vs 28.4%, respectively (HR=1.06; 95% CI 0.74 to 1.53; p=0.75) (Fig 2). A similar difference was found in the sensitivity analyses, with however a difference at the limit of significance for the analysis excluding pts with a molecule switch (adjusted HR=1.35; IC95% 0.96 to 1.92; p=0.085). The causes of discontinuation were due to inefficacy in 85% of cases and an adverse event in 12% of cases (19% in the SEK group and 9% in the UST group).Conclusion:In this first real-world study comparing UST and SEK persistence in PsA, the persistence of SEK was longer than that of UST. Subgroup analysis revealed this difference of persistence was restricted to patients treated in combination with MTX.Disclosure of Interests:Jean-Guillaume Letarouilly Grant/research support from: Research grant from Pfizer, Benoît Flachaire: None declared, Céline Labadie: None declared, Nicolas Cohen Speakers bureau: Novartis, Janssen, Maeva Kyheng: None declared, Jérémie SELLAM: None declared, Pascal Richette: None declared, Philippe Dieudé: None declared, Pascal Claudepierre Speakers bureau: Janssen, Novartis, Lilly, Bruno Fautrel Grant/research support from: AbbVie, Lilly, MSD, Pfizer, Consultant of: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Lilly, Janssen, Medac MSD France, Nordic Pharma, Novartis, Pfizer, Roche, Sanofi Aventis, SOBI and UCB, Eric Houvenagel Speakers bureau: Janssen, Novartis, Chi Duc Nguyen: None declared, Marie-Hélène Guyot: None declared, Nicolas Segaud: None declared, Frederic Maury: None declared, Laurent Marguerie: None declared, Xavier Deprez Speakers bureau: Novartis, Janssen, Jean-Hugues Salmon Speakers bureau: Novartis, Janssen, Guy Baudens: None declared, Corinne Miceli Richard: None declared, Elisabeth Gervais Speakers bureau: Novartis, Janssen, Roche, Pfizer, BMS, Abbvie, Isabelle CHARY VALCKENAERE: None declared, Pierre Lafforgue Speakers bureau: Novartis, Janssen, Damien LOEUILLE: None declared, Christophe Richez Consultant of: Abbvie, Amgen, Mylan, Pfizer, Sandoz and UCB., Thao Pham Speakers bureau: Novartis, Janssen, Lilly, Rene-Marc Flipo Speakers bureau: Novartis, Janssen, Lilly

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Computing Transmix in Complex Batch Transfers via the Mixing-Volume-Equivalent-Pipe Concept

2010 8th International Pipeline Conference, Volume 3 ◽

10.1115/ipc2010-31607 ◽

2010 ◽

Cited By ~ 1

Author(s):

Simone Rodrigues de Melo ◽

Felipe Bastos Freitas Rachid

Keyword(s):

Parabolic Equation ◽

Relative Error ◽

Flow Rate ◽

Real World ◽

Initial Value Problem ◽

Constant Flow ◽

Initial Value ◽

Flow Rates ◽

Constant Flow Rate ◽

Promising Tool

This paper presents a new concept — the mixing-volume-equivalent-pipe concept (MVEPC) — which is used to compute transmix volumes in complex batch transfers in an easy, quickly and very simple way. By taking advantage of the MVEPC, the mixing volume of a transfer carried out in a complex pipeline, with varying diameters and flow rates, can be calculated as if it had a unique diameter and a constant flow rate. To illustrate the applicability of the proposed methodology, a numerical example is presented for a transfer of typical products. The transmix volumes predicted by the MVEPC are compared with those obtained by solving the nonlinear initial-value problem for the dispersion of matter parabolic equation. The excellent agreement observed between these two methods, with relative error up to a maximum of 2.65%, enables the use of the MVEPC as a promising tool for estimating transmix volumes in real world batch transfer operations.

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