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

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

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

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

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

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

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

Rheumatology ◽  
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.

scholarly journals SAT0432 EFFECT OF SEX ON DISEASE CHARACTERISTICS AND DISEASE IMPACT IN PATIENTS WITH PSORIATIC ARTHRITIS (PsA): INSIGHTS FROM THE REAL-WORLD, OBSERVATIONAL MULTINATIONAL PsABio COHORT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1171.1-1173
Author(s):  
M. T. Nurmohamed ◽  
I. Van der Horst-Bruinsma ◽  
A. W. Van Kuijk ◽  
S. Siebert ◽  
P. Bergmans ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Physical Functioning ◽  
Real World ◽  
Comprehensive Treatment ◽  
Diagnosis Delay ◽  
Health State ◽  
Research Support ◽  
Disease Characteristics ◽  
Disease Impact

Background:Female sex has been associated with more severe disease and poorer treatment outcomes in PsA. These observations are often based on small populations or national cohorts/registries.Objectives:To investigate the effects of sex on disease characteristics and disease impact in PsA, using data of 929 consecutive patients (pts) from PsABio.Methods:PsABio is a real-world, non-interventional European study in PsA pts treated with UST or TNFi based on their rheumatologist’s choice. Observed male and female baseline (BL) data were described and compared using 95% CI.Results:Women in PsABio (n=512 [55%]) were numerically older than men (mean [SD]: 50.5 [12.7] / 48.7 [12.3] years, respectively). Women were more obese (BMI >30), % (95% CI): F: 35 (30, 39), M: 24 (20, 29), men more overweight (BMI >25–30): F: 31 (27, 36), M:51 (46, 57). Age at diagnosis, delay from first symptom to diagnosis, and disease duration were similar for both sexes.Women entered PsABio more often on 3rd line treatment, whereas men started on 1st-line biologic treatment more often (F/M 1st line 47%/55%; 2nd line 34%/33%; 3rd line 20%/12%). Numerically, concomitant MTX was given more often to women vs men (32% vs 27%). At BL, 60% of women and 64% of men were on NSAIDs; 7.9% and 2.5% on antidepressant drugs. Women had significantly more comorbidities, with numerically more cardiovascular disease and anxiety/depression, and 3 times more IBD.Women had significantly higher 68 tender joint counts (TJC): 13.0 vs 10.4, while 66 swollen joint counts were not significantly different: 5.8 vs 5.5. Axial or combined axial-peripheral disease was similarly frequent, in 29% of women and 26% of men (Figs. 1, 2).Clinical Disease Activity index for PSoriatic Arthritis (cDAPSA) was higher in women (31.8 vs 27.3); pt-reported levels of pain, global disease activity (VAS scales) and higher TJC contributed to this. While enthesitis prevalence (based on Leeds Enthesitis Index) was comparable, men had significantly more frequent dactylitis, nail disease and worse skin psoriasis. At BL, 3.4% of women vs 7.1% of men, were in MDA.Regarding physical functioning (HAQ-DI), impact of disease (PSAID-12) and quality of life (EQ5D-3L health state), women with PsA starting a biologic (b)DMARD, expressed significantly greater negative impact and more limitations due to their disease (Fig. 2).Conclusion:In routine care, women with PsA starting a bDMARD presented with worse outcomes over a range of assessments compared with men (higher pt-reported pain and disease activity, TJC, and worse physical functioning and QoL), while men had worse dactylitis and psoriasis. Follow-up analysis will report whether the effects of biologic therapy are different in both sexes. The increased prevalence of associated features related to pain and impact on functioning and QoL may indicate the need for a more comprehensive treatment approach for women to avoid unnecessary and premature bDMARD stop or switch.Acknowledgments:This study was funded by Janssen.Disclosure of Interests: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, Irene van der Horst-Bruinsma Grant/research support from: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Consultant of: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Arno WR van Kuijk Grant/research support from: Janssen, 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, 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, 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, Wim Noel Employee of: Janssen Pharmaceuticals NV, 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, 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, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB

THU0399 HOW DO TNF-ALPHA-INHIBITORS IN MEDICAL HISTORY AFFECT PATIENT REPORTED OUTCOMES AND RETENTION IN ANKYLOSING SPONDYLITIS PATIENTS TREATED WITH SECUKINUMAB IN REAL WORLD? - GERMAN AQUILA STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 436-437
Author(s):  
U. Kiltz ◽  
J. Brandt-Juergens ◽  
P. Kästner ◽  
E. Riechers ◽  
D. Peterlik ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Treatment Outcomes ◽  
Medical History ◽  
Physical Functioning ◽  
Real World ◽  
Interim Analysis ◽  
Retention Rates ◽  
Research Support ◽  
Kaplan Meier

Background:Secukinumab (SEC), a fully human monoclonal antibody that selectively inhibits interleukin 17A, is approved for treatment of patients with ankylosing spondylitis (AS). However, there is lack of real-world evidence on SEC treatment outcomes, disease activity, physical functioning and on its retention, especially in anti-tumor necrosis factor (anti-TNF) naïve patients and patients pretreated with different anti-TNFs in medical history.1Objectives:The aim of this interim analysis is to evaluate SEC treatment outcomes on disease activity, physical functioning and retention rates in AS patients stratified by number of anti-TNFs (naive, 1 or ≥2) in medical history.Methods:AQUILA is an ongoing, multi-center, non-interventional study. AS and psoriatic arthritis patients treated with SEC in daily practice are enrolled and observed from baseline (BL, d0 or d1 of study start) up to week 52 according to clinical routine. Real-world effectiveness of SEC was assessed prospectively and analyzed as observed. Here, we report interim results of SEC effectiveness on different treatment outcomes in AS patients by means of validated questionnaires such as patient´s global assessment (PGA), Bath Ankylosing Disease Activity Index (BASDAI), and Assessment of Spondyloarthritis Health Index (ASAS-HI). In addition, retention rates (time from study inclusion until premature SEC treatment discontinuation) were assessed through Kaplan-Meier plots. This interim analysis focuses onanti-TNF naïveand AS patients treated with1 anti-TNFor≥2 anti-TNFsin medical history. Wilcoxon tests were conducted to show significant differences between the subgroups.Results:At BL, 311 AS patients were included; 72 (23.2%) of them received SEC already for more than 1 day up to more than 6 months before BL. Most AS patients were anti-TNF-experienced (71.1%): 82 (26.4%) and 139 (44.7%) AS patients had 1 or ≥2 prior anti-TNF treatments, respectively. BL scores for PGA, BASDAI and ASAS-HI were similar between the different anti-TNF subgroups. Constant improvement was shown in all parameters from BL up to week 52, irrespective of prior anti-TNF treatment (PGA-anti-TNF naïve: 5.9 to 3.5, PGA-1 anti-TNF:6.1 to 4.2 and PGA-≥2 anti-TNFs:6.7 to 5.1; BASDAI-anti-TNF naïve: 5.3 to 3.4, BASDAI-1 anti-TNF:5.5 to 3.7 and BASDAI-≥2 anti-TNFs:5.7 to 4.7). However, overall better improvement was observed inanti-TNF naïvepatients, as seen by the example of ASAS-HI (Fig. 1). Between 30% and 40% of patients prematurely discontinued SEC treatment in the subgroups1 anti-TNFand≥2 anti-TNFs, respectively, while only about 20% did so in theanti-TNF naïveAS patients (Fig. 2).Conclusion:SEC has shown to improve disease activity, physical functioning and QoL in anti-TNF-naïve and pretreated AS patients in a real-world setting. The benefits of SEC were numerically more distinct in anti-TNF-naïve patients. Moreover, SEC demonstrated high retention rate, particularly in anti-TNF-naïve patients, thereby confirming previously reported real-world data on SEC from EuroSpA research collaboration network.2References:[1]Glintborg B, et al, Ann Rheum Dis 2013;72:1149-55; 2. Michelsen B, et al, Arthritis Rheumatol 2019:71(suppl10) #1822Disclosure of Interests: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, Elke Riechers Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Chugai, Novartis, UCB, Daniel Peterlik Employee of: Novartis Pharma GmbH, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, SanofiFigure 1.Change of health in AS patients treated with SEC stratified by anti-TNF pretreatmentFigure 2.SEC treatment retention depending on anti-TNF pretreatment (Kaplan-Meier plot)

Number of Patients Eligible for PCSK9 Inhibitors Based on Real-world Data From 2.5 Million Patients

2018 ◽  
Vol 71 (12) ◽  
pp. 1010-1017 ◽  
Author(s):  
Alberto Zamora ◽  
Luís Masana ◽  
Marc Comas-Cufi ◽  
Núria Plana ◽  
Àlex Vila ◽  
...  
Keyword(s):  
Real World ◽  
Pcsk9 Inhibitors ◽  
Real World Data ◽  
World Data ◽  
Number Of Patients

scholarly journals P232 Effectiveness of adalimumab biosimilar switching: real world data from a London rheumatology centre

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Shivanee Vigneswaran ◽  
Megan Galloway ◽  
Samuel Hanlon ◽  
Aoife Tynan ◽  
Animesh Singh
Keyword(s):  
Side Effects ◽  
Disease Activity ◽  
Real World ◽  
Biologic Therapy ◽  
Underlying Disease ◽  
Real World Data ◽  
Biologic Drugs ◽  
Control Activity ◽  
World Data ◽  
Long Term Treatment

Abstract Background Biologic drugs have revolutionised the management of many rheumatological diseases with remission or low disease activity now the realistic targets for treatment. However, given the chronic nature of most rheumatological disease and the need for long term treatment, there has been a significant increase in the cost associated with disease treatment. The advent of biosimilars offers an attractive target in reducing drug costs for payers. Biosimilar medications are thought to be equally efficacious as originator drugs. Real world data in adalimumab biosimilar switching is limited. In this audit we aim to examine the real-world outcomes from switching from originator Humira to biosimilar Amgevita in a London teaching hospital. Methods A list of all adult rheumatology patients on Amgevita was obtained through pharmacy records. All patients had been switched from Humira to Amgevita from February 2019. Using clinic letters and an in-house biologics database, data was collected on the underlying disease and the date of switch. Outcomes reviewed were disease activity scores pre and post switch, documented side effects and flare of disease activity following switch including decision to revert to originator Humira or change treatment. Results There was a total of 289 adult patients on Humira who switched to Amgevita. Of these patients, 28 in total discontinued treatment - 13 with rheumatoid arthritis, 10 with psoriatic arthritis and 5 with ankylosing spondylitis. 22 had to be switched back to Humira, with a further 4 patients approved to switchback and awaiting to restart. Two additional patients were switched to alternative biologic therapy due to inefficacy. A further 3 patients refused to switch onto Amgevita. Sixteen patients had documented flares, with one requiring admission and ten requiring local or systemic corticosteroid therapy to control activity. Seven patients had documented side effects which included chest pain, headache, rash and site reactions and one patient developed shingles post switch. Conclusion A total of 9.6% of patients switched to Amgevita had disease flare or side effects resulting in a switchback to Humira or alternative biologic therapy. For a biosimilar to be approved, efficacy and safety profiles needs to be comparable to the originator biological therapy and usually looks at two treatment naïve groups, rather than direct switch. Thereby, data on switches in therapy is limited. One systematic review looking at 11,053 patients with inflammatory arthritis treated with Etanercept and switched to Benepali, found 768 reverting to original therapy giving a lower total of 6.9%. We find that although no previous data of Amgevita, our figure of 9.6% appears high in the context of previously controlled inflammatory disease with Humira. Disclosures S. Vigneswaran None. M. Galloway None. S. Hanlon None. A. Tynan None. A. Singh None.

scholarly journals POS0608 SWITCHING OF TREATMENT FROM REFERENCE ETANERCEPT TO SANDOZ ETANERCEPT BIOSIMILAR IN PATIENTS WITH RHEUMATIC DISEASES: AN INTERIM ANALYSIS OF REAL-WORLD DATA FROM THE COMPACT STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 540.1-540
Author(s):  
M. Schmalzing ◽  
A. Askari ◽  
T. Sheeran ◽  
D. Walsh ◽  
J. De Toro Santos ◽  
...  
Keyword(s):  
Disease Activity ◽  
Real World ◽  
Targeted Therapies ◽  
Clinical Remission ◽  
Interim Analysis ◽  
Disease Activity Score ◽  
Research Support ◽  
Low Disease Activity ◽  
Group A ◽  
The Mean

Background:Sandoz etanercept (SDZ ETN) is a biosimilar of etanercept (ETN). COMPACT is an ongoing, non-interventional study, evaluating the effectiveness, safety, and quality of life with SDZ ETN treatment in patients (pts) with rheumatoid arthritis (RA), axial-spondyloarthritis (axSpA) or psoriatic arthritis (PsA) in real-world conditions.Objectives:We have reported an interim analysis, with the effectiveness and safety data focusing on pts who were in clinical remission or low disease activity under treatment with reference ETN or biosimilar ETN other than SDZ ETN (initial ETN; iETN) and switched to SDZ ETN.Methods:Pts aged ≥18 years for whom treatment with SDZ ETN were initiated are being enrolled. Pts were categorized under four treatment groups based on prior treatment status: Group A,pts on clinical remission or low disease activity under treatment with iETN and switched to SDZ ETN; Group B, pts who received targeted therapies and switched to SDZ ETN; Group C, biologic naïve considered uncontrolled with conventional therapy; Group D, DMARD naïve with recent diagnosis of RA considered suitable for treatment initiation with a biologic and started on treatment with SDZ ETN. Effectiveness assessments included Disease Activity Score 28-joint count Erythrocyte Sedimentation Rate (DAS28-ESR) or Ankylosing Spondylitis Disease Activity Score (ASDAS) until Week 24 after enrollment (baseline; BL) in the study. Functional disability was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). The effectiveness and safety results are reported for the pts who switched from iETN (Group A).Results:Of the 1437 pts recruited (analysis cut-off date: 16 Oct, 2020), 567 pts were switched from iETN, 163 were switched from other targeted therapies, 697 were biologic-naïve, and 10 were RA DMARD-naïve. Among pts who switched from iETN, 51.5% had RA, followed by axSpA (28.0%) and PsA (20.5%). Comorbidities were more frequent in pts with RA (70.2%) followed by PsA (58.6%) and axSpA (49.7%); musculoskeletal and connective tissue disorders were reported in 31.8% and 15.7% of pts with RA and axSpA, respectively. At BL, whilst receiving iETN, the mean (SD) DAS28-ESR scores were 2.5 (1.1) and 2.1 (1.1) in pts with RA and PsA, respectively (figure 1). The mean change from BL in DAS28-ESR score at Week 24 after switch to SDZ ETN was -0.1 (1.1) and 0 (1.0) in pts with RA and PsA, respectively. In pts with axSpA, the mean (SD) ASDAS score was 1.5 (0.7) at BL; mean change from BL in ASDAS score at Week 24 was 0.1 (0.5). At BL, the mean (SD) HAQ-DI scores were 0.8 (0.7), 0.5 (0.7) and 0.5 (0.6) in pts with RA, PsA and axSpA, respectively. Overall, the proportion of patients with at least one adverse event (AE) was 37.3%, 33.6% and 25.8% in pts with RA, PsA and axSpA, respectively. Serious AEs were reported in 6.5%, 1.7% and 3.1% of pts with RA, PsA, and axSpA, respectively. Injections site reactions were reported in 2.7%, 0.9% and 1.3% of pts with RA, PsA and axSpA, respectively.Figure 1.Disease activity in patients who switched from iETN to SDZ ETNConclusion:The interim analysis results shows that switch from iETN to SDZ ETN does not impact the effectiveness of ETN in pts with RA, axSpA or PsA, without any new safety signals.Disclosure of Interests:Marc Schmalzing Speakers bureau: Novartis, AbbVie, Chugai/Roche, Janssen-Cilag, Lilly, Consultant of: AstraZeneca, Chugai/Roche, Hexal/Sandoz, Gilead, AbbVie, Janssen-Cilag, Boehringer/Ingelheim, Grant/research support from: Travel grants: Chugai/Roche, Boehringer/Ingelheim, Celgene, Medac, Ayman Askari: None declared, Tom Sheeran Speakers bureau: Pfizer, UCB, Roche, Consultant of: Novartis, Pfizer, Grant/research support from: Novartis, UCB, Roche, David Walsh: None declared, Javier de Toro Santos: None declared, JULIO CESAR VAZQUEZ PEREZ-COLEMAN Speakers bureau: Sandoz, Abbvie, Sanofi, Fresenius, Charlotte Both Employee of: Sandoz employee Global Medical Affairs, Fabricio Furlan Employee of: Sandoz employee Global Medical Affairs, Sohaib HACHAICHI Employee of: Sandoz employee Global Medical Affairs, Herbert Kellner: None declared

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