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Background:AWARE is a real-world evidence-based (RWE) study evaluating the safety and efficacy of IV golimumab (GLM) and infliximab (IFX) in adults with RA.Objectives:Evaluate safety and efficacy of IV GLM and IFX in elderly AWARE participants.Methods:AWARE, a prospective non-interventional study (88 US sites), enrolled patients (pts) initiating either IV GLM or IFX. Pt management was at the discretion of treating rheumatologists. In a post hoc analysis, pts were grouped by age (Results:1270 pts were enrolled (685 IV GLM; 585 IFX). 1047 (82%) pts were female; mean age was 60 yrs (57% 1 rates of serious AEs (SAEs) and serious infections increased with age for both IV GLM and IFX; however, increases were more notable in IFX- than IV GLM-treated pts ≥65 yrs. The incidence of serious infections was highest in pts ≥75 yrs for both treatments, although small sample size may limit data interpretation. No increase in opportunistic infections, including Varicella, was observed in pts ≥65 vs Table 1.% of pts with ≥1 AE through W52 DBLIV GLMIFX≥65 yrs≥75 yrs≥65 yrs≥75 yrsPatients, n3513349137021546Discontinued due to AE8.5%12.6%16.5%15.1%17.7%21.7%AE52.4%58.4%57.1%63.5%66.5%71.7%Most common AEs (≥5% of pts in either treatment group)Nausea3.7%3.3%3.3%8.4%6.0%2.2%Worsening of RA5.4%4.5%3.3%7.3%7.0%4.3%Upper respiratory tract infection5.7%5.1%4.4%6.2%5.6%2.2%Pruritis1.4%2.4%3.3%6.8%2.8%2.2%Sinusitis7.1%3.3%0%3.8%3.7%2.2%Urinary tract infection4.8%5.1%5.5%4.3%5.1%6.5%SAE7.7%16.8%20.9%9.7%18.6%26.1%Infection30.5%27.2%27.5%32.2%28.8%32.6%Serious infection3.7%6.3%7.7%3.5%7.9%15.2%Neoplasms benign, malignant and unspecified0.6%2.7%1.1%0.8%2.3%6.5%Latent tuberculosis0.3%0%00.3%0%0%Opportunistic infection1.4%1.8%4.4%1.9%1.4%4.3%Infusion reaction5.1%2.7%1.1%17.3%8.8%8.7%Death0.3%2.4%2.2%0%2.3%6.5%Conclusion:Elderly RA pts receiving IV GLM or IFX in this RWE study demonstrated similar safety and efficacy as reported in Phase 3 trials.2,3 The higher rates of AEs, discontinuations due to AE, and SAEs (mainly serious infections) observed in pts ≥65 yrs are in line with increased safety events seen in elderly vs younger individuals in the general population. Rates of AEs, SAEs, and infusion reactions were higher for IFX vs IV GLM. Infusion reactions were more common in pts References:[1]Castle SC. Clin Infect Dis 2000;31:578–85.[2]Lipsky PE, et al. N Engl J Med 2000;343:1594-602.[3]Weinblatt ME, et al. Ann Rheum Dis 2013;72:381-9.Disclosure of Interests:Joy Schechtman: None declared, Aaron Broadwell Speakers bureau: Amgen, AbbVie, Eli Lilly, Horizon, Janssen, Mallinckrodt, Novartis, Pfizer, Radius, Sanofi/Regeneron, and UCB, Consultant of: AbbVie, Amgen, Aurinia, Celegene, Eli Lilly, Janssen, Novartis, Pfizer, and Sandoz, Shelly Kafka Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Shawn Black Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Stephen Xu Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Wayne Langholff Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Sergio Schwartzman Shareholder of: Amgen, Boston Scientific, Gilead, Medtronic, and Pfizer, Speakers bureau: AbbVie, Janssen, Eli Lily, Novartis, Pfizer, Regeneron, Sanofi, and UCB, Consultant of: AbbVie, Gilead, Eli Lilly, Janssen, Myriad, Novartis, Regeneron, Samsung, Sanofi, and UCB

Background:AWARE is a phase-4 observational study designed to provide real-world assessment of Golimumab (GLM) IV & infliximab (IFX) in patients (pts) with rheumatoid arthritis (RA).Objectives:To assess patient-reported aspects of social, mental, & physical health through the 8th infusion (≈1 year of treatment) using Patient Reported Outcomes Measurement Information System (PROMIS), a validated, disease-agnostic set of health assessment instruments.Methods:AWARE enrolled 1270 RA pts initiating treatment with GLM/IFX. The 52 week analysis set included pts with ≥1-year treatment or those discontinued and, while enrolled, completed PROMIS-29 or PROMIS short form (SF) questionnaires. PROMIS instruments were administered at baseline & prior to infusions 2, 5, & 8. The raw score was converted into a standardized T-score with a mean of 50 and SD of 10.Results:At baseline, treatment groups were balanced on demographics & medical characteristics. Most pts were white (87.0% GLM, 86.2% IFX) & female (83.4% GLM, 82.4% IFX). Mean ages were 58.5 ±12.96 years for GLM & 59.6 ±13.24 years for IFX. Overall, 35.3% GLM & 42.9% IFX pts were bio-naïve. The proportion of GLM & IFX pts with prior exposure to 1 or 2 biologics was similar; however, 20.1% GLM pts vs 10.8% IFX pts had exposure to ≥3 biologics. Methotrexate use was similar between GLM (76.4%) & IFX pts (75.0%). Based on mean PROMIS T-scores at baseline (Table 1), Fatigue, Pain Interference, & Physical Function domains approached or exceeded 1 SD worse than those of general US population. Through the 8th infusion, GLM- & IFX-treated pts achieved meaningful improvement based on mean changes from baseline in most PROMIS-29 domains & respective SFs with no significant difference between GLM and IFX. The percentage of GLM or IFX pts with improvements of ≥3, ≥5, or ≥10 units change in T-scores increased from infusion 2 through infusion 8.Conclusion:RA pts treated with GLM or IFX achieved comparable improvements across PROMIS-assessed social, mental, & physical health. PROMIS-29 was able to detect change to subsequent anti-tumor necrosis factor-α therapies.Table 1.Mean (SD) Change from Baseline PROMIS-29 Domain and Short Form T-Scores: 52 Week Analysis SetGLMIFXLSM difference (95% CI)*Anxiety (4-item)N=6N=570Baseline53.4 (10.13)54.6 (10.53)Change from baseline at infusion 8N=223 -2.6 (8.10)N=286-3.7 (7.86)-0.29 (-1.54, 0.97)Depression (4-item)BaselineN=67451.9 (9.83)N=57452.5 (10.21)Change from baseline at infusion 8N=225-2.1 (7.56)N=287-2.3 (7.89)0.49 (-0.72, 1.70)Fatigue (4-item)BaselineN=67158.4 (9.91)N=57459.4 (9.99)Change from baseline at infusion 8N=225-3.4 (8.72)N=281-3.1 (7.77)0.69 (-0.64, 2.03)Short form Fatigue 7aBaselineN=68159.1 (8.51)N=57659.7 (8.25)Change from baseline at infusion 8N=228-3.2 (7.40)N=287-2.4 (6.35)1.01 (-0.11, 2.14)Pain interference (4-item)BaselineN=67963.0 (7.56)N=57463.9 (7.80)Change from baseline at infusion 8N=227-4.2 (8.23)N=284-3.1 (7.77)1.84 (0.55, 3.13)Short form Pain interference 6bBaselineN=68061.9 (7.45)N=57662.8 (7.54)Change from baseline at infusion 8N=228-3.8 (7.88)N=287-3.2 (6.67)1.31 (0.15, 2.48)Physical function (4-item)BaselineN=67838.2 (6.79)N=57138.0 (6.90)Change from baseline at infusion 8N=2242.2 (5.64)N=2831.9 (5.85)-0.76 (-1.73, 0.21)Sleep disturbance (4-item)BaselineN=67154.6 (8.72)N=569N=55.5 (8.61)Change from baseline at infusion 8N=221-1.4 (7.45)N=281-1.7 (7.61)0.23 (-0.96, 1.42)Social participation (4-item)BaselineN=67343.7 (8.40)N=57442.9 (8.77)Change from baseline at infusion 8N=2253.2 (8.15)N=2833.4 (7.48)-0.10 (-1.36, 1.16)*Least squares mean (LSM) difference & confidence interval (CI) are based on analysis of covariance controlling for baseline PROMIS score using inverse probability of treatment weighted propensity score.Disclosure of Interests:Clifton Bingham Consultant of: AbbVie, BMS, Eli Lilly, Gilead, Janssen, Pfizer, Regeneron/Sanofi, Grant/research support from: Bristol-Myers Squibb, Shelly Kafka Employee of: Janssen Research & Development, LLC, Shawn Black Employee of: Janssen Research & Development, LLC, Stephen Xu Employee of: Janssen Research & Development, LLC, Wayne Langholff Employee of: Janssen Research & Development, LLC, Jeffrey Curtis Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB

Background:AWARE (Comparative and Pragmatic Study of Golimumab IV Versus Infliximab in Rheumatoid Arthritis) is an ongoing Phase 4 comparator study designed to provide a real-world assessment of intravenous golimumab (GLM) and intravenous infliximab (IFX) in patients (pts) with rheumatoid arthritis (RA). The study recently reached its primary endpoint (comparison of overall incidence of infusion reactions in GLM- vs IFX-treated pts after 52 weeks) with the last patient reaching 52 weeks of treatment or discontinuation from the study. AWARE also records prior use of biologic medications and concomitant use of methotrexate (MTX).Objectives:To assess the incidence of infusion reactions among GLM and IFX pts reported at baseline by examining the influence of prior biologic exposure or concurrent use of MTX.Methods:AWARE is a prospective, noninterventional, observational, multicenter, 3-year study conducted in the US. RA patients (1,270 adults) were enrolled at the time of initiating treatment with GLM or IFX. All treatment decisions were made at the discretion of the treating rheumatologist. An infusion reaction was any adverse event that occurred during an infusion or within 1 hour after the infusion of either GLM or IFX. Imputations were not performed on these AWARE data. Data shown are mean ± standard deviation.Results:Demographics are shown in Table 1 and the incidence of infusion reactions in different AWARE cohorts is shown in Table 2. GLM and IFX pts were comparable in sex and utilization of MTX at baseline. Both age and disease duration of GLM pts was greater than IFX pts by ~2 years. There was a higher proportion of bionaïve pts in IFX-treated group compared to GLM-treated group. Overall, infusion reactions occurred more frequently among IFX-treated pts compared to GLM-treated pts. The difference in infusion reaction rates between IFX- and GLM-treated pts was also evident among subgroups of bionaïve vs non-bionaïve pts, and among MTX non-users vs MTX users (characteristics reported at baseline). GLM pts did not report any serious or severe infusion reactions. These were reported rarely (3/585 pts) in IFX-treated pts. Among GLM and IFX pts with an infusion reaction, 55.6% of GLM and 77.1% of IFX pts had at least one medication for infusion reaction. Infusion reactions accounted for 9.7% and 35.1% of discontinuations due to adverse events in GLM and IFX pts, respectively.Table 1.Baseline Characteristics in the AWARE StudyGLM (n=685)IFX (n=585)Age (years)60.9 ± 13.4358.0 ± 12.85Sex (% female)85.0 %79.5 %Disease Duration (years)9.16 ± 9.9757.20 ± 9.716Bionaïve (%)33.0%48.6%MTX plus (%)75.4%75.1%MTX=methotrexateTable 2.Infusion Reactions in AWARE in Subsets of Patients ± Prior Biologic Use or ± Concurrent MTXGLM (n=685)IFX (n=585)GLM (n=685)IFX (n=585)BionaïveNon-BionaïveBionaïveNon-BionaïveNo MTX UseMTXUseNo MTX UseMTX UseInfusion Reactions6/242(2.5%)21/443(4.7%)36/251(14.3%)47/334(14.1%)15/265(5.7%)12/420(2.9%)44/229(19.2%)39/356(11.0%)Medication for Infusion Reactions33.3%59.1%78.9%73.6%50.%58.3%73.6%77.6%MTX=methotrexateConclusion:Whether bionaïve, non-bionaïve, MTX non-user or MTX user at baseline, the incidence of infusion reactions was notably lower among GLM- vs IFX-treated pts. Serious and/or severe infusion reactions did not occur among GLM pts and were rare among IFX pts. IFX was more commonly administered mediation for an infusion reaction compared to GLM. Infusion reactions accounted for almost four times the number of discontinuations related to adverse events in IFX pts compared to GLM pts.Disclosure of Interests: :Sergio Schwartzman Grant/research support from: Janssen Research & Development, LLC, Consultant of: AbbVie, Crescendo Bioscience, Dermtech, Eli Lilly and Company, Gilead Sciences, Janssen Pharmaceutica, Myriad Genetics, Novartis, Regeneron, Samsung, Sanofi, UCB, Speakers bureau: AbbVie, Eli Lilly and Company, Genentech, Janssen Pharmaceutica, Novartis, Pfizer, Regeneron, Sanofi, UCB, Aaron Broadwell Grant/research support from: Janssen Research & Development, LLC, Janssen, Eli Lilly, Consultant of: AbbVie, Amgen, AstraZeneca, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Sandoz, Speakers bureau: AbbVie, Amgen, Celgene, GSK, Horizon, Janssen, Mallinckrodt, Novartis, Pfizer, Radius, Sanofi-Regeneron, UCB, Alan Kivitz Shareholder of: AbbVie, Amgen, Gilead, GSK, Pfizer Inc, Sanofi, Consultant of: AbbVie, Boehringer Ingelheim,,Flexion, Genzyme, Gilead, Janssen, Novartis, Pfizer Inc, Regeneron, Sanofi, SUN Pharma Advanced Research, UCB, Paid instructor for: Celgene, Genzyme, Horizon, Merck, Novartis, Pfizer, Regeneron, Sanofi, Speakers bureau: AbbVie, Celgene, Flexion, Genzyme, Horizon, Merck, Novartis, Pfizer Inc, Regeneron, Sanofi, Shawn Black Employee of: Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC, Stephen Xu Employee of: Janssen Research & Development, LLC, Wayne Langholff Employee of: Janssen Research & Development, LLC, Shelly Kafka Employee of: Janssen Scientific Affairs, LLC

Background:Use of patient-reported outcomes (PROs) to assess health-related quality of life in clinical practice, research studies, and clinical trials in rheumatoid arthritis (RA) remains an ongoing area of research. SF-36 is commonly used in RA trials but is not feasible for routine use in clinical practice settings. ThePatientReportedOutcomesMeasurementInformationSystem (PROMIS) may address this gap but has not been widely assessed in RA patients starting therapy in a real-world comparative effectiveness study, nor examined in that setting in relation to the SF36 and Clinical Disease Activity Index (CDAI).Objectives:To assess validity of PROMIS based on Comparative and Pragmatic Study of Golimumab Intravenous (IV) Versus Infliximab in Rheumatoid Arthritis (AWARE), an ongoing Phase 4 study providing real-world assessment of IV tumor necrosis factor inhibitor (TNFi) medications in RA patients.Methods:AWARE is a prospective, non-interventional, 3-year study conducted at 88 US sites. RA patients were enrolled when initiating TNFi treatment. Treatment decisions were made by treating rheumatologists. We report baseline PROMIS-29 (7 domains and pain intensity), PROMIS Pain Interference (PI) Short Form (SF) 6b (PI6b) and PROMIS Fatigue (F) Short Form 7a (F7a), domain T-Scores, and SF-36 subdomain and Component Scores (CS) in AWARE patients. Here we report baseline data obtained from the final 1-year AWARE dataset. Correlations between PROMIS measures and comparable SF-36 component scores were calculated using Pearson correlations. Data is shown as mean ± standard deviation (SD).Results:At baseline, mean CDAI of all patients (n=1262) was 32.3±15.6, with 70.4% in high disease activity (HDA, CDAI>22), 22.8% in moderate disease activity (MDA, CDAI: >10 and ≤22), 6.1% in low disease activity (LDA, CDAI: >2.8 and ≤10), and 0.7% in remission (CDAI ≤2.8). Mean PROMIS scores were >0.5 SD worse than population means for Physical Function (PF, 38.1±6.84), PI (63.4±7.68), F (58.8±9.95), Sleep Disturbance (55.1±8.68); and Ability to Participate in Social Roles/Activities (PSRA, 43.4±8.58). Baseline Depression and Anxiety were within 0.5 SD of population T-scores. PI6b, F7a, and P29 domain T-scores correlated with the comparable SF-36 subdomain and component scores (r’s >0.58), except sleep for which no comparable SF-36 element was applicable. Examples include: P6b (r=-0.80) and P29-PI (0.81) with SF-36 Bodily Pain; F7a (-0.77) and P29-F (-0.77) with SF-36 Vitality; P29-PF with SF-36 PF (0.77), Role-Physical (0.69), and Physical CS (0.73); P29 Anxiety with SF-36 Mental Health (-0.72), Role-Emotional (-0.56), Mental CS (-0.70); and P29-PRSA with SF-36-Social Functioning (0.71). Mean PROMIS-29 T-scores (except Anxiety and Sleep Disturbance) among patients with HDA were significantly different from patients with MDA, LDA or remission (p < 0.001 for all). Further, mean PROMIS T-scores of PF, F, PSRA, PI, Pain Intensity, PI6b and P7a among patients with MDA were significantly different from patients with more or less active RA (by CDAI category).Conclusion:Analysis of baseline results from a large cohort of RA patients indicates high correlations between individual P29 domain T-scores and SF-36 component scores, as well as categorical CDAI, providing strong evidence of PROMIS construct validity in a real-world population of RA patients.Disclosure of Interests:Clifton Bingham Grant/research support from: Bristol-Myers Squibb, Consultant of: Bristol-Myers Squibb, Shelly Kafka Employee of: Janssen Scientific Affairs, LLC, Shawn Black Employee of: Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC, Stephen Xu Employee of: Janssen Research & Development, LLC, Wayne Langholff Employee of: Janssen Research & Development, LLC, Jeffrey Curtis Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB

Background Pt-reported outcomes (PRO) are used to assess pt-related benefit in clinical trials. Inflammatory arthritis (IA) pts are equally receptive to intravenous (IV) or subcutaneous (SC) biologic treatment 1 . Objectives We obtained PRO data to understand characteristics of pts who receive IV biologic agents for IA. Methods This was a questionnaire-based study conducted at a rheumatology practice with extensive clinical trial experience. A total of 100 pts enrolled & are included in this final analysis. Inclusion criteria: a diagnosis of IA with IV biologic use for ≥3 mo; ≥18 yrs age; able to read, write & speak English, willing to complete the questionnaire & a signed informed consent form. IV biologic treatment was per clinical practice; there were no treatment assignments & study drug was not supplied. The questionnaire had 30 questions which pts completed prior to receiving a regularly scheduled dose of IV biologic. Results Mean (±SD) age of pts was 58.35 (±14.64) yrs with mean disease duration of 10.1 (±8.13) yrs (range 0.7–45 years). Pts were Caucasian (38%), African American (28%), Latino/Hispanic (22%), Asian/Pacific Islander (1%) & 11% not identified. IV biologics used were infliximab [IFX](71%), rituximab [RTX](12%), tocilizumab [TCZ](10%), abatacept [ABT](6%) & golimumab [GLM](1%). The mean duration of current IV therapy was 4.07 (±3.27) yrs (range 0.1 to 16.0 yrs). Pts9 favorability perception of IV therapy BEFORE & AFTER starting IV therapy is shown in the Figure. Amongst all pts, “Extremely favorable” increased (p Conclusions These results suggest that among IA pts receiving IV biologic therapy for treatment of IA, there is a high degree of pt satisfaction, including a similar favorability perception of IV therapy among pts who switched from a SC to an IV biologic. Our results support the concept that when there is a shared decision making discussion with pts regarding biologic treatments, the option of IV therapy should be an essential part of that discussion & that the IA pts9 perspective should be given meaningful consideration. References Bolge SC et al Arthritis Rheum 2013;65 Suppl 10:1023 Disclosure of Interest N. Gaylis Grant/research support from: Janssen Scientific Affairs, LLC, J. Sagliani Grant/research support from: Janssen Scientific Affairs, LLC, S. Black Employee of: Janssen R & D, LLC, K. Tang Employee of: Janssen R & D, LLC, R. Dehoratius Employee of: Janssen Scientific Affairs, LLC, D. Parenti Employee of: Janssen Scientific Affairs, LLC