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Clinical and Economic Impact of The Use Of Infliximab Biosimilar Inflectra In Rheumatoid Arthritis, Psoriatic Arthropathy And Ankylosing Spondylitis Patients
A546
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6
Westhovens R1, Ravelingien I2, Van de Vyvere K3, Pansar I4, Purcaru O5, Kumke T6, Gyselbrecht L7 1University Hospitals KU Leuven, Leuven, Belgium, 2Onze Lieve Vrouwziekenhuis, Aalst, Belgium, 3AZ Groeninge, Kortrijk, Belgium, 4UCB Pharma, Brussels, Belgium, 5UCB Pharma, Slough, UK, 6UCB Pharma, Monheim, Germany, 7Algemeen Stedelijk Ziekenhuis, Aalst, Belgium
Objectives: To evaluate the effect of certolizumab pegol (CZP) treatment on workplace and household productivity over 52 weeks (wks) in rheumatoid arthritis (RA) patients in real-world clinical practice in Belgium. Methods: RA0046 was an observational, non-interventional, prospective study. Eligible patients were ≥ 18 years with moderate to severe active RA suitable for treatment with CZP according to the SmPC and Belgian local reimbursement criteria (DAS28≥ 3.7). Disease burden at study baseline on workplace and household productivity over the preceding month was evaluated using the validated, RA-specific Work Productivity Survey. Data are presented for all patients who received ≥ 1 CZP dose with ≥ 1 post-baseline assessment of ≥ 1 primary efficacy variable (full analysis set). Missing data were imputed using last observation carried forward. Results: Of 141 patients enrolled, 93 (66%) completed the study to Wk52. At baseline, patients had active disease: mean (SD) DAS28: 4.8 (0.9), tender joint count: 8.8 (6.1), swollen joint count: 6.4 (4.1), HAQ-DI: 1.5 (0.6), and Pain (0–100mm VAS): 65.5 (19.4). All patients reported a high burden on productivity at baseline. At Wk52, patients missed fewer days of paid and household work ([mean baseline/Wk52] paid: 5.9/2.9; household: 8.9/5.2), suffered fewer days of ≥ 50% reduced productivity at work and home ([baseline/Wk52] work: 5.1/3.0; home: 7.9/4.7), and reported reduced interference of arthritis in paid and household work ([mean baseline/Wk52, 0–10 scale] paid: 5.4/2.7; household: 5.7/3.2). Improvements in clinical outcomes were also observed; by Wk52, 71% of patients achieved a good EULAR response, and 66% achieved EULAR remission. The safety profile of CZP was comparable to previous reports, with no new safety signals identified. Conclusions: CZP treatment over 52 wks was associated with improvements in workplace and household productivity in real-world clinical practice in Belgium; comparable improvements in clinical outcomes were also observed.
PMS85 Long-Term Improvements in Workplace and Household Productivity and Social Participation Over 4 Years of Certolizumab Pegol Treatment in Patients with Axial Spondyloarthritis, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis van der Heijde D1, Braun J2, Rudwaleit M3, Landewé R4, Purcaru O5, Kavanaugh A6 University Medical Center, Leiden, The Netherlands, 2Rheumazentrum Ruhrgebiet, Herne, Germany, 3Endokrinologikum Berlin, Berlin, Germany, 4Zuyderland Medical Center, Heerlen, The Netherlands, 5UCB Pharma, Slough, UK, 6UC San Diego School of Medicine, La Jolla, CA, USA
1Leiden
Objectives: To report the long-term effect of certolizumab pegol (CZP) on workplace and household productivity, social participation, and caregiver burden up to 4 years (204 weeks [wks]) in patients with axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS, meeting modified New York criteria) and non-radiographic axSpA (nr-axSpA). Methods: RAPID-axSpA (NCT01087762) was doubleblind and placebo-controlled to Wk24, dose-blind to Wk48 and open-label to Wk204. Patients had active axSpA, according to ASAS criteria, including AS and nr-axSpA patients. Patients originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4) continued on their assigned dose in the open-label period. The validated arthritis-specific Work Productivity Survey (WPS; administered Q4W) assessed the impact of axSpA on workplace and household productivity. A socio-economic module administered Q4W assessed caregiver burden. Descriptive statistics (LOCF imputation) in patients originally randomized to CZP are summarized to Wk204. Results: 325 patients were randomized, of whom 218 received CZP from Wk0. Of patients randomized to CZP at baseline, 93% completed Wk24 and 65% Wk204. Employed CZP patients (72% at baseline) reported reductions in workplace absenteeism and presenteeism to Wk24, with continued improvements to Wk204 (baseline: mean 1.8 days missed/month, mean 5.2 days with reduced productivity/month vs Wk204: mean 0.2 days missed/month, mean 1.4 days with reduced productivity/month). CZP patients also reported continued improvements in household productivity and social participation to Wk204. After 4 years of CZP treatment, patients were less likely to require regular assistance from relatives/friends in usual activities (40.8% [baseline]; 12.4% [Wk204]) and more likely not to require any assistance (55.5% [baseline]; 85.3% [Wk204]). Similar improvements were observed in AS and nr-axSpA. Conclusions: The initial improvements with CZP in workplace and household productivity, increased participation in social/leisure activities and caregiver burden were continued long-term to 4 years in axSpA, AS and nr-axSpA patients.
MUSCULAR-SKELETAL DISORDERS – Health Care Use & Policy Studies PMS86 Clinical and Economic Impact of The Use Of Infliximab Biosimilar Inflectra In Rheumatoid Arthritis, Psoriatic Arthropathy And Ankylosing Spondylitis Patients Borras Blasco J1, Gracia-Pérez A2, Casterá D1, Rosique-Robles D1, Abad J1, Heskouri Benlemlih H1 1Hospital Sagunto, Sagunto, Spain, 2Hospital de Sagunto, Sagunto, Spain
Objectives: The aim of this study is determine the persistence, clinic and economic impact of the use of Inflectra®in Rheumatoid arthritis (RA), psoriatic arthritis (PA) and ankylosing spondylitis (AS) patients Methods: Observational, retrospective cohort study patients treated with Inflectra® during Jun 2015 to June 2016. We collected age, sex, indication, dose and persistence of Inflectra®. Efficacy endpoints included DAS28 and BASDAI. Safety was also assessed. We determined the real cost of Inflectra® treatment for each patient from invidualized IV administration
and correlated dates during the study period were collected from Outpatient Clinic Hospital Pharmacy software. We simulated the real cost of these patients if the patients received Remicade®. Cost savings were calculated using Inflectra® and Remicade® hospital prices. Results: From Jun 2015 to Jun 2016, 14 patients (7 women; age 42±8 years; weight 81±17 kg; 9 AS, 4 RA, 1 PA) were treated with Inflectra®. 8 (57%) patients were naïve to anti-tnf-alfa drugs and 6 (43%) patients were preteated with at least 1 anti-tnf-alfa drug. At Jun 2016, 12 (85%) patients continued on Inflectra® treatment. 2 patients discontinued therapy due to relapse of their AS. Patients with Inflectra® presented a persistence of 5.5±1,9 months (EA 5,7±2,0, AR 4,1±1,1, AP 7) with a range of 2.8 to 8.4 months. Any infusion adverse reaction was reported. Total associated costs of the Inflectra® treatment throughout the observation period were 57730€ . If these patients had been treated with Remicade® the total cost of therapy would have been 74767€ . The implementation of the procedure to use Inflectra® for all new prescriptions of Infliximab saved 17037€ . Conclusions: Inflectra® produces cost savings when used in anti tnf alfa drugs naïve and anti tnf alfa drugs pretreated patients. At a time when therapy cost is an unavoidable component of health-care treatment decisions, Inflectra® could be a cost-effective option for selected RA, PA and AS patients. PMS87 Real World Utilization of Biological Agents in Rheumatoid Arthritis Patients: A French National Claims Database Analysis Over The Period 2010–2014 Laurendeau C, Lafuma A, Trancart M Cemka-Eval, Bourg La Reine, France
Objectives: To describe the current medical management of Rheumatoid Arthritis (RA) patients in routine practice in a national representative sample of patients, focusing on biological agents (BA) uptake. Methods: The “Échantillon Généraliste des bénéficiaires” (EGB) database is a 1/97 representative sample of the national claims database covering the whole French population. RA patients were identified as adults (age > 18) benefiting from full coverage (“ALD” eligibility criteria) for RA (ICD-10 codes M05-06) from 2010 to 2014. Patients treated with BA were defined as RA patients with at least one claim for at least one BA over the period 2010-2014. First line initiations were identified by the absence of a BA claim during a period of 3 months, followed by at least one BA claim. Results: Over the 4-year period, 46,992 patients (21.8% of the RA population) had a reimbursed BA. Number of RA patients treated with BA increased over time from 31,538 in 2010 to 38,630 in 2014. Over the period, 30,102 patients begun a first line BA, most of them (61%) being initiated with etanercept and adalimumab. In these patients, treatment discontinuation occurred mainly during the first two years, with respectively 64%, 51% and 39% of the patients still undergoing first line treatment at the end of year 1, 2 and 4. Among the 38,630 patients treated in 2014, 47% were still treated with the first line BA, 23% had one switch, 15% had two switches and 15% had three or more. Conclusions: Claims database is a useful tool to describe the medical management of RA patients and especially the use of medications in real life. Number of BA treated patients increased over time in France, and almost half of the patients remained treated with the 1st line treatment. PMS88 Effectiveness of A Referral Program For Early Arthritis Diagnosis At Primary Care Centers In Portugal - Final Results From The Siara Study Laires PA1, Dezerto R1, Mesquita R1, Fonseca JE2, Cernadas R3, Miranda LC4, Silva JC5, Costa L6, Nogueira AM1 1Merck Sharp & Dohme, Oeiras, Portugal, 2Centro Hospitalar Lisboa Norte, EPE - Hospital Santa Maria, Lisbon, Portugal, 3ARS Norte, Oporto, Portugal, 4Instituto Português de Reumatologia, Lisbon, Portugal, 5Garcia de Orta Hospital, Almada, Portugal, 6Hospital São João (Centro Hospitalar de São João, EPE), Oporto, Portugal
Objectives: We aimed to evaluate the impact of a referral program on the identification and appropriate referral to the rheumatologist of patients with suspected inflammatory arthritis. Methods: SIARA (Referral Strategies and Disease Education Impact on Diagnosis and Referral of Axial Spondyloarthritis and Rheumatoid Arthritis Patients) was an observational prospective, randomized (by clusters of primary care centers) study to analyze the impact of Referral Support Actions (RSA) consisting of physician educational sessions about the disease and implementation of referral recommendations. It was conducted during three years between 18th July 2012 and 9th June 2015. The 28 participating primary care centers were randomly and by clusters assigned to RSA or control group (with no intervention). Both RSA and control groups identified and referred patients with suspected inflammatory arthritis to the rheumatology unit of the reference hospital. The main studied outcome is the correct diagnosis of rheumatoid arthritis and all inflammatory arthritis cases confirmed by the rheumatologist of the reference hospital. Results: Out of a total of 340 participants, 206 patients were referred to a rheumatologist: 96 RSA patients and 110 control patients. Mean age was 48.2 years (range: 18-65) and 87.1% were female. Despite the positive trend, no significant between-group differences were seen regarding the improvement of rheumatoid arthritis referral. About 7.3% (n= 7) of RSA patients and 2.7% (n= 3) of controls had a confirmed diagnosis of rheumatoid arthritis by the rheumatologist (OR= 2.8; 95% CI 0.7-11.2; Chi-square p-value= 0.128). However, the rate of confirmed inflammatory arthritis was significantly superior in RSA with 16.9% (n= 14) versus 6.0% (n= 5) in the controls (OR= 3.2; 95% CI 1.1-9.2; p= 0.028). Conclusions: Our findings suggest a positive impact of referral activities, namely physician educational sessions, at the primary care centers. This should be further analyzed and considered by healthcare deciders in order to improve health outcomes in inflammatory arthritis. PMS89 Monitoring Evidence-Based Technology Incorporation: The Case of Biological Rheumatoid Arthritis Drugs In Brazil From 2010 to 2014 Oliveira AV, Ramalho WM, Silva EN
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6
Westhovens R1, Ravelingien I2, Van de Vyvere K3, Pansar I4, Purcaru O5, Kumke T6, Gyselbrecht L7 1University Hospitals KU Leuven, Leuven, Belgium, 2Onze Lieve Vrouwziekenhuis, Aalst, Belgium, 3AZ Groeninge, Kortrijk, Belgium, 4UCB Pharma, Brussels, Belgium, 5UCB Pharma, Slough, UK, 6UCB Pharma, Monheim, Germany, 7Algemeen Stedelijk Ziekenhuis, Aalst, Belgium
Objectives: To evaluate the effect of certolizumab pegol (CZP) treatment on workplace and household productivity over 52 weeks (wks) in rheumatoid arthritis (RA) patients in real-world clinical practice in Belgium. Methods: RA0046 was an observational, non-interventional, prospective study. Eligible patients were ≥ 18 years with moderate to severe active RA suitable for treatment with CZP according to the SmPC and Belgian local reimbursement criteria (DAS28≥ 3.7). Disease burden at study baseline on workplace and household productivity over the preceding month was evaluated using the validated, RA-specific Work Productivity Survey. Data are presented for all patients who received ≥ 1 CZP dose with ≥ 1 post-baseline assessment of ≥ 1 primary efficacy variable (full analysis set). Missing data were imputed using last observation carried forward. Results: Of 141 patients enrolled, 93 (66%) completed the study to Wk52. At baseline, patients had active disease: mean (SD) DAS28: 4.8 (0.9), tender joint count: 8.8 (6.1), swollen joint count: 6.4 (4.1), HAQ-DI: 1.5 (0.6), and Pain (0–100mm VAS): 65.5 (19.4). All patients reported a high burden on productivity at baseline. At Wk52, patients missed fewer days of paid and household work ([mean baseline/Wk52] paid: 5.9/2.9; household: 8.9/5.2), suffered fewer days of ≥ 50% reduced productivity at work and home ([baseline/Wk52] work: 5.1/3.0; home: 7.9/4.7), and reported reduced interference of arthritis in paid and household work ([mean baseline/Wk52, 0–10 scale] paid: 5.4/2.7; household: 5.7/3.2). Improvements in clinical outcomes were also observed; by Wk52, 71% of patients achieved a good EULAR response, and 66% achieved EULAR remission. The safety profile of CZP was comparable to previous reports, with no new safety signals identified. Conclusions: CZP treatment over 52 wks was associated with improvements in workplace and household productivity in real-world clinical practice in Belgium; comparable improvements in clinical outcomes were also observed.
PMS85 Long-Term Improvements in Workplace and Household Productivity and Social Participation Over 4 Years of Certolizumab Pegol Treatment in Patients with Axial Spondyloarthritis, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis van der Heijde D1, Braun J2, Rudwaleit M3, Landewé R4, Purcaru O5, Kavanaugh A6 University Medical Center, Leiden, The Netherlands, 2Rheumazentrum Ruhrgebiet, Herne, Germany, 3Endokrinologikum Berlin, Berlin, Germany, 4Zuyderland Medical Center, Heerlen, The Netherlands, 5UCB Pharma, Slough, UK, 6UC San Diego School of Medicine, La Jolla, CA, USA
1Leiden
Objectives: To report the long-term effect of certolizumab pegol (CZP) on workplace and household productivity, social participation, and caregiver burden up to 4 years (204 weeks [wks]) in patients with axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS, meeting modified New York criteria) and non-radiographic axSpA (nr-axSpA). Methods: RAPID-axSpA (NCT01087762) was doubleblind and placebo-controlled to Wk24, dose-blind to Wk48 and open-label to Wk204. Patients had active axSpA, according to ASAS criteria, including AS and nr-axSpA patients. Patients originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4) continued on their assigned dose in the open-label period. The validated arthritis-specific Work Productivity Survey (WPS; administered Q4W) assessed the impact of axSpA on workplace and household productivity. A socio-economic module administered Q4W assessed caregiver burden. Descriptive statistics (LOCF imputation) in patients originally randomized to CZP are summarized to Wk204. Results: 325 patients were randomized, of whom 218 received CZP from Wk0. Of patients randomized to CZP at baseline, 93% completed Wk24 and 65% Wk204. Employed CZP patients (72% at baseline) reported reductions in workplace absenteeism and presenteeism to Wk24, with continued improvements to Wk204 (baseline: mean 1.8 days missed/month, mean 5.2 days with reduced productivity/month vs Wk204: mean 0.2 days missed/month, mean 1.4 days with reduced productivity/month). CZP patients also reported continued improvements in household productivity and social participation to Wk204. After 4 years of CZP treatment, patients were less likely to require regular assistance from relatives/friends in usual activities (40.8% [baseline]; 12.4% [Wk204]) and more likely not to require any assistance (55.5% [baseline]; 85.3% [Wk204]). Similar improvements were observed in AS and nr-axSpA. Conclusions: The initial improvements with CZP in workplace and household productivity, increased participation in social/leisure activities and caregiver burden were continued long-term to 4 years in axSpA, AS and nr-axSpA patients.
MUSCULAR-SKELETAL DISORDERS – Health Care Use & Policy Studies PMS86 Clinical and Economic Impact of The Use Of Infliximab Biosimilar Inflectra In Rheumatoid Arthritis, Psoriatic Arthropathy And Ankylosing Spondylitis Patients Borras Blasco J1, Gracia-Pérez A2, Casterá D1, Rosique-Robles D1, Abad J1, Heskouri Benlemlih H1 1Hospital Sagunto, Sagunto, Spain, 2Hospital de Sagunto, Sagunto, Spain
Objectives: The aim of this study is determine the persistence, clinic and economic impact of the use of Inflectra®in Rheumatoid arthritis (RA), psoriatic arthritis (PA) and ankylosing spondylitis (AS) patients Methods: Observational, retrospective cohort study patients treated with Inflectra® during Jun 2015 to June 2016. We collected age, sex, indication, dose and persistence of Inflectra®. Efficacy endpoints included DAS28 and BASDAI. Safety was also assessed. We determined the real cost of Inflectra® treatment for each patient from invidualized IV administration
and correlated dates during the study period were collected from Outpatient Clinic Hospital Pharmacy software. We simulated the real cost of these patients if the patients received Remicade®. Cost savings were calculated using Inflectra® and Remicade® hospital prices. Results: From Jun 2015 to Jun 2016, 14 patients (7 women; age 42±8 years; weight 81±17 kg; 9 AS, 4 RA, 1 PA) were treated with Inflectra®. 8 (57%) patients were naïve to anti-tnf-alfa drugs and 6 (43%) patients were preteated with at least 1 anti-tnf-alfa drug. At Jun 2016, 12 (85%) patients continued on Inflectra® treatment. 2 patients discontinued therapy due to relapse of their AS. Patients with Inflectra® presented a persistence of 5.5±1,9 months (EA 5,7±2,0, AR 4,1±1,1, AP 7) with a range of 2.8 to 8.4 months. Any infusion adverse reaction was reported. Total associated costs of the Inflectra® treatment throughout the observation period were 57730€ . If these patients had been treated with Remicade® the total cost of therapy would have been 74767€ . The implementation of the procedure to use Inflectra® for all new prescriptions of Infliximab saved 17037€ . Conclusions: Inflectra® produces cost savings when used in anti tnf alfa drugs naïve and anti tnf alfa drugs pretreated patients. At a time when therapy cost is an unavoidable component of health-care treatment decisions, Inflectra® could be a cost-effective option for selected RA, PA and AS patients. PMS87 Real World Utilization of Biological Agents in Rheumatoid Arthritis Patients: A French National Claims Database Analysis Over The Period 2010–2014 Laurendeau C, Lafuma A, Trancart M Cemka-Eval, Bourg La Reine, France
Objectives: To describe the current medical management of Rheumatoid Arthritis (RA) patients in routine practice in a national representative sample of patients, focusing on biological agents (BA) uptake. Methods: The “Échantillon Généraliste des bénéficiaires” (EGB) database is a 1/97 representative sample of the national claims database covering the whole French population. RA patients were identified as adults (age > 18) benefiting from full coverage (“ALD” eligibility criteria) for RA (ICD-10 codes M05-06) from 2010 to 2014. Patients treated with BA were defined as RA patients with at least one claim for at least one BA over the period 2010-2014. First line initiations were identified by the absence of a BA claim during a period of 3 months, followed by at least one BA claim. Results: Over the 4-year period, 46,992 patients (21.8% of the RA population) had a reimbursed BA. Number of RA patients treated with BA increased over time from 31,538 in 2010 to 38,630 in 2014. Over the period, 30,102 patients begun a first line BA, most of them (61%) being initiated with etanercept and adalimumab. In these patients, treatment discontinuation occurred mainly during the first two years, with respectively 64%, 51% and 39% of the patients still undergoing first line treatment at the end of year 1, 2 and 4. Among the 38,630 patients treated in 2014, 47% were still treated with the first line BA, 23% had one switch, 15% had two switches and 15% had three or more. Conclusions: Claims database is a useful tool to describe the medical management of RA patients and especially the use of medications in real life. Number of BA treated patients increased over time in France, and almost half of the patients remained treated with the 1st line treatment. PMS88 Effectiveness of A Referral Program For Early Arthritis Diagnosis At Primary Care Centers In Portugal - Final Results From The Siara Study Laires PA1, Dezerto R1, Mesquita R1, Fonseca JE2, Cernadas R3, Miranda LC4, Silva JC5, Costa L6, Nogueira AM1 1Merck Sharp & Dohme, Oeiras, Portugal, 2Centro Hospitalar Lisboa Norte, EPE - Hospital Santa Maria, Lisbon, Portugal, 3ARS Norte, Oporto, Portugal, 4Instituto Português de Reumatologia, Lisbon, Portugal, 5Garcia de Orta Hospital, Almada, Portugal, 6Hospital São João (Centro Hospitalar de São João, EPE), Oporto, Portugal
Objectives: We aimed to evaluate the impact of a referral program on the identification and appropriate referral to the rheumatologist of patients with suspected inflammatory arthritis. Methods: SIARA (Referral Strategies and Disease Education Impact on Diagnosis and Referral of Axial Spondyloarthritis and Rheumatoid Arthritis Patients) was an observational prospective, randomized (by clusters of primary care centers) study to analyze the impact of Referral Support Actions (RSA) consisting of physician educational sessions about the disease and implementation of referral recommendations. It was conducted during three years between 18th July 2012 and 9th June 2015. The 28 participating primary care centers were randomly and by clusters assigned to RSA or control group (with no intervention). Both RSA and control groups identified and referred patients with suspected inflammatory arthritis to the rheumatology unit of the reference hospital. The main studied outcome is the correct diagnosis of rheumatoid arthritis and all inflammatory arthritis cases confirmed by the rheumatologist of the reference hospital. Results: Out of a total of 340 participants, 206 patients were referred to a rheumatologist: 96 RSA patients and 110 control patients. Mean age was 48.2 years (range: 18-65) and 87.1% were female. Despite the positive trend, no significant between-group differences were seen regarding the improvement of rheumatoid arthritis referral. About 7.3% (n= 7) of RSA patients and 2.7% (n= 3) of controls had a confirmed diagnosis of rheumatoid arthritis by the rheumatologist (OR= 2.8; 95% CI 0.7-11.2; Chi-square p-value= 0.128). However, the rate of confirmed inflammatory arthritis was significantly superior in RSA with 16.9% (n= 14) versus 6.0% (n= 5) in the controls (OR= 3.2; 95% CI 1.1-9.2; p= 0.028). Conclusions: Our findings suggest a positive impact of referral activities, namely physician educational sessions, at the primary care centers. This should be further analyzed and considered by healthcare deciders in order to improve health outcomes in inflammatory arthritis. PMS89 Monitoring Evidence-Based Technology Incorporation: The Case of Biological Rheumatoid Arthritis Drugs In Brazil From 2010 to 2014 Oliveira AV, Ramalho WM, Silva EN