M. Govoni

SAT0403 Treatment with Golimumab or Infliximab Reduces Health Resource Utilization and Increases Work Productivity in Patients with Ankylosing Spondylitis in The QUO-VADIS Study, A Large, Prospective Real-Life Cohort

Background The true cost of treating Ankylosing Spondylitis (AS) comprises several elements including not only medication, but also healthcare resource utilization (HCRU), reduced work productivity, and absenteeism. Objectives We report the results from the QUality of Life as Outcomes and its VAriation with DIsease States (QUO-VADIS) study on the effect of the anti-tumor necrosis factor (TNF) agents, golimumab (GLM) and infliximab (IFX), on HCRU for patients with AS as well as their ability to work. Methods This was a prospective observational study in bionaïve AS patients (modified New York criteria) newly treated with GLM or IFX (originator) in a clinical practice setting. Patients were followed-up for ∼6 months of treatment with GLM or IFX and data was collected at baseline (BL), and at 3 and 6 months. The assessment of HCRU was done by evaluating data on the use of concomitant medications, hospitalizations (inpatient care or acute care) and visits in day care and outpatient settings; HCRU data reflected the prior 3 months for each timepoint. Work productivity and activity impairment (WPAI) was assessed by the number of work days missed as well as quantifying absenteeism, presenteeism, work impairment, and activity using the WPAI instrument adapted to Spondylarthritis (WPAI-SpA)(1); WPAI was based on the 7 days prior to the administration of the questionnaire. Results 963 patients received ≥1 dose of medication. The vast majority (78%, n=751) was treated with GLM, while the rest (22%, n=221) received IFX. Mean age of the patients was 42.7 years, 61.4% were male. Concomitant medication usage for AS treatment was reported by 84.3% of patients, the vast majority of whom received NSAIDs, followed by analgesics, DMARDs and corticosteroids. At BL, the percent of patients who reported hospitalizations (inpatient care) in the prior 3 months was 13.6%, which decreased to 3.1% at 6 months, while outpatient care in the 3 months prior to BL was reported by 39.4% of patients, which decreased to 19.0% at 6 months. The percent of patients receiving acute emergency care in the 3 months prior to BL reduced from 1.6%0.3% at 6 months. Further details on HCRU at BL and at 6 months are shown in the Table. The mean (SD) number of days at work, missed due to AS, was reduced from 6.3 (31.1) days at BL to 2.7 (12.3) days at 6 months. Results for WPAI-SpA assessment are presented in the Table. Conclusions In patients with AS newly treated with GLM (almost 80% of the study population) or IFX for 6 months, HCRU was reduced, as shown by the shorter mean duration of hospitalizations and the proportion of patients receiving acute, inpatient or outpatient care. Additionally, work productivity and activity increased, and patients reported fewer days of work missed due to AS after 6 months of treatment. References Tang et al. Arthritis Care Res 2011; 63: S337–349 Disclosure of Interest P. Sarzi-Puttini: None declared, F. Van Den Bosch Consultant for: Merck & Co., Inc.; Abbvie; Novartis; Pfizer; UCB; Bristol Myers Squibb, Celgene, Janssen, P. Claudepierre: None declared, S. Sajjan Employee of: Merck Sharp & Dohme, N. Vastesaeger Employee of: Merck Sharp & Dohme, M. Govoni Employee of: Merck Sharp & Dohme, S. Kachroo Employee of: Merck Sharp & Dohme

SAT0393 Clinical and Quality of Life Improvements Observed with Golimumab and Infliximab in A Large Real-Life Ankylosing Spondylitis Population: Results from The Quo-Vadis Study

Background Loss of health-related quality of life (HRQoL) is documented in Ankylosing Spondylitis (AS) patients and improvement has been observed upon therapy with anti-tumor necrosis factor (TNF) agents. Parameters such as higher ASDAS, elevated CRP and younger age have been described in literature to be associated with improved clinical outcomes. Objectives The relationship between baseline (BL, pre-anti-TNF treatment) disease-specific parameters and HRQoL improvement during anti-TNF therapy with golimumab (GLM) or infliximab (IFX) was evaluated in the QUality of Life as Outcomes and its VAriation with DIsease States (QUO-VADIS) study. Methods This prospective observational study included bio-naïve AS patients (modified New York criteria) newly treated with GLM or IFX (originator). Patients were followed-up for ∼6 months (data collected at BL, 3, and 6 months). Demographic and clinical characteristics, disease activity and HRQoL were summarized accordingly. The Classification and Regression Trees (CART) analysis evaluated the association of BL parameters (demographic, clinical, disease severity) with change in HRQoL at 6 months, measured by an improvement of ≥5 points of the Short-Form 36 (SF-36) Physical Component Summary (PCS) score. Clinical parameters included Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), and AS Disease Activity Scores (ASDAS). Results 963 patients received ≥1 dose of medication; 78% received GLM and 22%received IFX. Mean age was 42.7 years, 61.4% were male, and 65.3% had ≥ one comorbidity. Mean symptom and diagnosis duration were 11.6 and 5.3 years, respectively, and 63.8%of patients were Human Leukocyte Antigen (HLA)-B27 positive. At BL, mean BASDAI, ASDAS-CRP and BASFI scores were 6.21, 3.59 and 5.34, respectively. High and very high ASDAS disease activity was observed in 41.4% and 49.3% of patients, respectively. Clinical and HRQoL improvements were shown in all collected measures following 6 months of treatment with GLM or IFX, as documented in the Table. PCS response at 6 months (improvement of ≥5 points from BL) was achieved in 52.3% (n=504) of patients. Using CART analysis, the baseline parameters, and their cutoff values, associated with HRQoL improvement as measured by SF-36 PCS response at 6 months were ASDAS (≥3.48), C-Reactive Protein (CRP) (≥8.55 mg/L), and age (≤35.5 years), and BASFI (≥1.15). This algorithm correctly identified 57.5% (sensitivity) of the patients who had improvement on PCS >5 points and 61.0% (specificity) of the patients who had improvement on PCS ≤5 points with ROC-AUC=0.61. Conclusions This study demonstrated clinical and HRQoL improvements over 6 months in a large, real-world population of AS patients newly treated with GLM or IFX. The QUO-VADIS study also demonstrates, for the first time, the association of parameters such as higher ASDAS, elevated CRP and younger age with improvements in HRQoL and with a more robust response. The use of these predicting factors may aid clinicians in better evaluating which patients to start on antiTNF therapy with GLM or IFX. Disclosure of Interest F. Van Den Bosch Consultant for: Abbvie, Bristol Myers Squibb, Celgene, Janssen, Merck & Co., Inc., Novartis, Pfizer and UCB, R.-M. Flipo Grant/research support from: Ipsen Pharma, Menarini France, and Savie, J. Braun Consultant for: Abbvie (Abbott), Amgen, Boehringer Ingelheim, Bristol-Myers-Squibb, Celgene, CELLTRION, Centocor, Chugai, EBEWE Pharma, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, S. Sajjan Employee of: Merck Sharp & Dohme, S. Kachroo Employee of: Merck Sharp & Dohme, N. Vastesaeger Employee of: Merck Sharp & Dohme, M. Govoni Employee of: Merck Sharp & Dohme

THU0435 Treatment Persistence with Subcutaneous Biologic Therapies in Patients with Psoriatic Arthritis (PSA)

Background The treatment landscape of psoriatic arthritis has evolved in recent years, with the introduction of subcutaneous TNF-alpha blockers in the EU. These changes in the treatment landscape could affect how patients are managed with psoriatic arthritis. Objectives The objective of this study was to describe persistence with subcutaneous biologic over 12 months for newly treated PsA patients and evaluate the impact of prior DMARD use Methods This was a retrospective analysis using IMS Disease Analyzer-Germany, an electronic medical records database. Adult (≥18 years of age) PsA patients who initiated therapy with subcutaneous biologics between January 1, 2009 and June 30, 2012 were included in the analysis. The first subcutaneous biologic prescription date served as their index date. Continuous observation of at least 12 months pre- and post-index date was required. Patients who were prescribed any biologic during the pre-index period or diagnosed with rheumatoid arthritis, ankylosing spondylitis, Crohns disease, or ulcerative colitis during the study period were excluded from the study population. A chi-square test was used to measure differences between patients with and without use of pre-index DMARD. A multivariate logistic regression was created to assess the impact of DMARD use on persistence, controlling for baseline characteristics Results A total of 197 biologic-naïve PsA patients were selected. Of these, 89 were free of PsO. The mean (SD) age of the patients was 49 (11) years, with 50% being female. The majority of patients (61%) indexed on adalimumab, while the remainder indexed on etanercept (35%) and golimumab (4%). In the overall PsA population, the persistence rate with the index subcutaneous biologic was 54.3%, with similar results among those with and without DMARD uses (53% vs 56%, respectively). Multivariate analysis did not identify any significant predictors for persistence, including DMARD use (OR: 1.05; 95% CI: 0.53-2.07) and psoriasis (OR: 1.07; 95% CI: 0.56- 2.03 Conclusions More than half of the PsA patients were persistent with the index subcutaneous biologic over a 12-month period with similar persistence rates observed among those with and without psoriasis and DMARD use Disclosure of Interest R. Lyu Employee of: Merck, Q. Ding Employee of: Merck, M. Govoni Employee of: Merck, C. Makin: None declared, J. Korn: None declared, T. Fan Employee of: Merck, A. Ogbonnaya: None declared, C. Black Employee of: Merck, S. Kachroo Employee of: Merck

Treatment Persistence With Subcutaneous Biologic Therapies in Patients With Psoriatic Arthritis (Psa)

Background • Psoriatic arthritis (PsA) is an inflammatory peripheral and/or axial arthritis associated with psoriasis, usually seronegative for rheumatoid factors1 • Patients with PsA also have debilitating skin disease, and nearly half may also have a spinal disease.2 PsA is estimated to affect 2.0% to 3.0% of the general population3 • To date, few studies have examined treatment persistence of subcutaneous biologics in a real-world setting in Europe, specifically in Germany Objectives • To examine persistence on therapy over 12 months for PsA patients who were newly treated with subcutaneous biologics • To assess if there are differences in treatment persistence between patients with and without prior DMARD experience

AB1091 Treatment Persistence with Subcutaneous Biologic Therapies in Patients with Rheumatoid Arthritis

Background Subcutaneous biologic therapies are usually prescribed to patients with moderate to severe Rheumatoid Arthritis (RA), particularly in patients whose condition is not responding to conventional disease-modifying antirheumatic drugs (DMARDs). Objectives The objective of this study was to describe treatment persistence over 12 months for RA patients who were newly treated with subcutaneous biologics, and assess differences between patients with and without prior DMARDs experience. Methods A retrospective cohort study was conducted using the Electronic Medical Record database of IMS Disease Analyzer-Germany. Patients who were ≥18 years old, had at least one ICD-10 diagnosis code of RA during the study period, and had exposure to a subcutaneous biologic (certolizumab, etanercept, adalimumab, anakinra, or golimumab) between January 1, 2009 and June 30, 2012 were selected, with the first prescription date serving as the index date. Patients were required to have continuous observation for a minimum of 12 months prior to and after the index date. Patients with a prescription for any biologic (subcutaneous or intravenous) during the pre-index period, and/or those diagnosed with ankylosing spondilitis, psoriatic arthritis or other conditions treated with subcutaneous biologics either pre- or post-index were excluded from the study population. Persistence with any subcutaneous biologic agent was defined in consecutive days from treatment initiation until treatment discontinuation (continuous ≥60-day lapse in medication coverage). Patients were stratified into one of two mutually exclusive cohorts, based upon pre-index use (or lack thereof) of DMARDs. A chi-square test was used to measure the difference in the percentage of persistent patients and a logistic regression model was created to assess differences in the likelihood of being persistent, controlling for baseline demographic and clinical characteristics. Results A total of 576 RA patients without biologic experience during the pre-index period were selected, 471 with prior DMARDs use and 105 without. The mean (SD) age of the patients was 57 (13) years, with 75% being female. The most frequent comorbidities were hypertension (10%), osteoporosis (9%), and diabetes (6%). Majority of the patients were treated with etanercept (46%) and adalimumab (40%). Overall a mean of 246 days on subcutaneous biologic treatment over a period of 12 months was observed. About 52% of the patients persisted on any biologics for at least 12 months. A significantly higher percentage of patients with pre-index DMARDs were persistent (56% vs. 33%; p=0.0001), and after controlling for pre-index characteristics, patients with a pre-index DMARDs had 2.49 times the odds of being persistent compared to those without pre-index DMARDs use (OR: 2.49, 95% CI: 1.54-4.04). Conclusions More than half of the patients were persistent over 12 months after newly initiating their index subcutaneous biologic in Germany. Patients with pre-index DMARDs were significantly more likely to persist on biologic treatment than patients without pre-index DMARDs. Further investigation is needed to understand whether specific drugs have different persistence patterns. Disclosure of Interest R. Lyu Employee of: Merck & Co. Inc, M. Govoni Employee of: Merck Sharp & Dohme Limited, Q. Ding: None declared, T. Fan Employee of: Merck & Co. Inc, A. Ogbonnaya Grant/research support: Merck & Co. Inc, P. Donga Grant/research support: Merck & Co. Inc, J. Korn Grant/research support: Merck & Co. Inc, C. Makin Grant/research support: Merck & Co. Inc DOI 10.1136/annrheumdis-2014-eular.4656

AB0273 Efficacy and safety of add-on golimumab treatment in patients with rheumatoid arthritis receiving concomitant methotrexate or leflunomide

Background Current labeling requires rheumatoid arthritis (RA) patients receiving golimumab (GLM) to receive concomitant methotrexate (MTX), and most studies have investigated GLM on the background of MTX treatment. Limited information is available regarding GLM as add-on therapy to disease-modifying antirheumatic drugs (DMARD) such as leflunomide (LEF). Objectives To evaluate the effectiveness and safety of GLM as add-on therapy in biologic-naïve patients with RA receiving concomitant MTX or LEF in clinical settings. Methods GO-MORE was an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ≥3.2). Patients received 50-mg SC GLM once monthly for 6 months. The primary outcome was the percentage of patients with good or moderate EULAR DAS28-ESR response at 6 months. Remission (DAS28-ESR <2.6) and minimal or no functional impairment (Health Assessment Questionnaire-Disability Index [HAQ-DI] ≤0.5) were also assessed. Treatment effects were evaluated with chi-square tests. Post hoc analyses evaluated outcomes in patients who received concomitant MTX or concomitant LEF. Results Patients receiving GLM with concomitant MTX (alone or with other DMARDs) or GLM with concomitant LEF (with no other DMARDs) accounted for 81.2% (2663/3280) and 9.3% (303/3270) of the total study population, respectively. The concomitant MTX and LEF subgroups had comparable baseline disease characteristics, including mean DAS28-ESR (5.43 and 5.25, respectively), DAS28-CRP (5.99 and 5.79, respectively), and HAQ-DI (1.44 and 1.36, respectively). These values were similar to the baseline means of the overall population. At month 6, similarly high EULAR response rates were noted in the GLM with concomitant MTX (85%) and GLM with concomitant LEF (81%) subgroups (Table). Similar EULAR responses were also observed in patients receiving GLM+MTX without other DMARDs (83%) and GLM+MTX+LEF without other DMARDs (78%). Serious treatment-emergent adverse events (TEAEs) occurred in 5.1% (136/2656) of the concomitant MTX subgroup and 6.8% (21/309) of the LEF subgroup. There were 5 (0.19%) and 0 deaths in the concomitant MTX and LEF subgroups, respectively. Conclusions Overall, add-on SC GLM therapy was highly efficacious with concomitant MTX or LEF in patients with active RA despite DMARD therapy. Safety profiles were consistent with those of previous studies of GLM. Disclosure of Interest J. Wollenhaupt Consultant for: Abbott, Biotest, BMS, Chugai, MSD, Medac, Merck, MSD, Pfizer, Roche, and UCB., Speakers bureau: Abbott, Biotest, BMS, Chugai, MSD, Medac, Merck, MSD, Pfizer, Roche, and UCB., A. Alonso-Ruiz: None Declared, W. Spieler: None Declared, J. Beier: None Declared, J. Molina: None Declared, R. Yao Employee of: Merck, M. Govoni Employee of: Merck, N. Vastesaeger Employee of: Merck, H. Weng Employee of: Merck

THU0178 Comprehensive Disease Control with Golimumab in Patients with Rheumatoid Arthritis

Background Comprehensive management of rheumatoid arthritis (RA) involves clinical goals such as remission and low disease activity (LDA) and outcomes important to patients such as daily functioning and minimization of pain. Objectives To evaluate comprehensive disease control with 6 months of add-on golimumab (GLM) treatment in a broad sample of patients with active RA despite disease-modifying antirheumatic drugs (DMARDs). Methods GO-MORE was an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ≥3.2) despite DMARD treatment. Patients received 50-mg SC GLM once monthly for 6 months. Patients completed the Health Assessment Questionnaire Disability Index (HAQ-DI) and patient acceptable symptom state (PASS). PASS was assessed with one yes/no question as to whether the patient would be satisfied to stay in their current disease state. Effects of baseline disease activity on DAS28-CRP, remission, and LDA (based on DAS28-ESR and simplified disease activity index [SDAI]) were evaluated with chi-square tests. Results Among 3280 efficacy-evaluable patients, the baseline mean age was 52.3 (SD=12.8) years, and mean disease duration was 7.63 (SD=7.903) years. The baseline mean DAS28-ESR, DAS28-CRP, and HAQ-DI values were 5.97 (SD=1.10), 5.41 (SD=1.00), and 1.44 (SD=0.67), respectively. At baseline, 21.3% of patients had moderate disease activity (DAS28-ESR EULAR 3.2 to 5.1), and 78.7% had high disease activity (DAS28-ESR EULAR >5.1). At month 6, remission based on DAS28-ESR and SDAI was attained by 23.9% and 14.2% of patients, respectively. LDA based on DAS28-ESR and SDAI was reached by 37.4% and 48.3% of patients, respectively, at month 6. Month 6 DAS28-CRP levels of <2.6 or 2.6 to <3.2 occurred in 32.5% and 49.5% of patients, respectively. Patients with moderate baseline disease activity were more likely to reach remission or low disease activity state than those with high baseline disease activity (Table). At month 6, PASS and minimal or no functional impairment (HAQ-DI ≤0.5) were achieved by 66.0% and 37.4% of patients, respectively. Conclusions In patients who had inadequate control of RA with a variety of nonbiologic DMARDs, 6 months of add-on treatment with once-monthly GLM resulted in good comprehensive disease control as measured by composite indices of clinical activity and patient-reported outcomes. Disclosure of Interest B. Combe Grant/research support from: Pfizer, Roche-Chugai, Consultant for: Merck, Pfizer, Roche-Chugai, and UCB, D. Veale Grant/research support from: Abbott, MSD, Pfizer and Roche, Consultant for: MSD, Pfizer, Roche and UCB, Speakers bureau: MSD, Pfizer, Roche and UCB, R. Burgos-Vargas: None Declared, G. Szűcs: None Declared, M. Leirisalo-Repo Consultant for: MSD, R. Yao Employee of: Merck, M. Govoni Employee of: Merck, N. Vastesaeger Employee of: Merck, H. Weng Employee of: Merck