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Objective Evaluate tolerability and effectiveness of golimumab-IV versus infliximab in patients with rheumatoid arthritis (RA) in a real-world setting. Methods AWARE, a prospective, real-world, pragmatic, observational, multicenter, phase 4 study, enrolled RA patients when initiating golimumab-IV or infliximab. Treatment decisions were made by the treating rheumatologist. The approved doses for RA are 2 mg/kg at weeks 0, 4, then Q8W for golimumab-IV and 3 mg/kg at weeks 0, 2, 6, then Q8W (dose escalation permitted) for infliximab. A prespecified formal interim analysis was conducted. The primary endpoint was the incidence of infusion reactions (any adverse event that occurred during or within 1 h of infusion) through week 52. Major secondary endpoints were mean change from baseline in CDAI at months 6 and 12 in biologic-naïve patients (non-inferiority margin in the CDAI = 6). Baseline characteristics were adjusted using propensity scores with inverse probability of treatment weights (IPTW). Results In the formal interim analysis (golimumab-IV, n = 479; infliximab, n = 354), the incidence of infusion reactions was significantly lower with golimumab-IV vs. infliximab (3.6 vs. 17.6%, p

Dose escalation of infliximab in both primary and secondary nonresponders is widely reported; however, the usefulness of dose escalation has been disputed. The objective of this analysis is to evaluate trends in clinical efficacy following multiple infliximab dose escalations in patients with rheumatoid arthritis (RA). Patients enrolled in a US RA registry were included if they initiated infliximab at 3 mg/kg every 8 weeks, received ≥ 1 infliximab dose escalation within 12 months of initiation, and had ≥ 1 visit following dose escalation. Trends in mean Clinical Disease Activity Index (CDAI) and Health Assessment Questionnaire (HAQ) scores from visits following dose escalations were evaluated. In patients who received 2 or 3 dose escalations, the initial (1 or 2) dose escalations resulted in reduced mean CDAI scores, but subsequent escalations did not further reduce disease activity. In patients who received ≥ 4 dose escalations, mean CDAI scores did not further reduce disease activity over time. Mean HAQ scores were stable over time in patients who received 2 or 3 dose escalations. In patients who received ≥ 4 dose escalations, mean HAQ scores decreased following 1 dose escalation but progressively increased following subsequent dose escalations. Initial dose escalations (from 3 mg/kg to the equivalent of approximately 5 to 7 mg/kg) may be useful in controlling disease activity; however, there may be diminishing clinical benefit of further escalations, which can also increase the potential risk for infection and increase incremental drug costs. • Initial infliximab dose escalations (1 to 2) may be useful in lowering disease activity in patients with rheumatoid arthritis. • There does not appear to be a clinical benefit in infliximab dose escalations above the equivalent of 5 to 7 mg/kg.

OBJECTIVE To evaluate whether intravenous (IV) golimumab produces improvements in skin and nail symptoms that are concomitant with improvements in quality of life (QoL) and joint symptoms in patients with psoriatic arthritis. METHODS Patients were randomized to either IV golimumab 2 mg/kg at weeks 0, 4, then every 8 weeks (q8w) through week 52 or placebo at weeks 0, 4, then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52. Assessments included Psoriasis Area and Severity Index (PASI), modified Nail Psoriasis Severity Index (mNAPSI), Dermatology Life Quality Index (DLQI), and American College of Rheumatology (ACR) rheumatoid arthritis response criteria. RESULTS Through week 24, achievement of PASI 75/90/100 responses (P ≤ .0098) and mean improvements in mNAPSI (-11.4 vs -3.7; P < .0001) and DLQI (-9.8 vs -2.9; P < .0001) were significantly greater with golimumab versus placebo. Responses were maintained in patients treated with golimumab through week 52. In placebo-crossover patients, increases in the proportion of patients achieving PASI 75/90/100 responses were observed from weeks 24 to 52, and mean improvements in mNAPSI (from -3.7 to -12.9) and DLQI (from -2.9 to -7.8) increased from weeks 24 to 52. Simultaneous achievement of PASI and DLQI responses, PASI and ACR responses, and mNAPSI and DLQI responses were also observed. Similar responses were observed for all assessments regardless of concomitant methotrexate use. CONCLUSION Improvements in skin and nail psoriasis symptoms with IV golimumab in patients with psoriatic arthritis were concomitant with improvements in QoL and arthritis disease activity through 1 year.

Background PROMIS (Patient Reported Outcomes Measurement Information System) has been used in rheumatoid arthritis (RA) patients (Pts) to assess disease activity across multiple domains (i.e. physical function, fatigue, pain interference). AWARE (Comparative and Pragmatic Study of Golimumab IV Versus Infliximab in Rheumatoid Arthritis) is an ongoing Phase 4 study designed to provide a real-world assessment of intravenous Tumor Necrosis Factor inhibitor (TNFi) medications in RA pts. The study utilizes PROMIS and Clinical Disease Activity Index (CDAI) to assess effectiveness. Objectives This analysis examined select PROMIS measures to assess (1) relationship between baseline (BL) CDAI and PROMIS-scores, (2) responsiveness of PROMIS after initiation of TNFi and (3) relationship between PROMIS T-scores of the 4 item Profile29v2 Fatigue and Pain Interference domains and respective PROMIS Short Forms (SF). Methods AWARE is a prospective, noninterventional, 3-year study at 100 US sites. RA pts were enrolled when initiating TNFi treatment. Treatment decisions are at the discretion of the treating rheumatologist. We report on data from Pts’ BL PROMIS Pain Interference 6b (PI), Fatigue7a (F), Profile29v2 and CDAI. PROMIS T-scores were compared across CDAI disease category (high, moderate etc) using ANOVA. We dichotomized pts based on whether their BL T-score was within 0.5SD of the population mean (i.e. ‘normal’) or not to evaluate for effect modification in the subsequent change in PROMIS T-scores. Data shown are mean ± std dev. Results Pts (N=1220) were 59.5± 13.2 yrs, disease duration 8.2 ± 9.9 yrs, 83.4% female, body weight 85.1± 24.2 kg, BMI 31.4 ± 8.51, BL CDAI 32.4 ± 15.6. A significant relationship between PROMIS T-scores (PI, F) and BL CDAI disease activity category was confirmed. There was minimal change in T-score of pts with BL PI and F T-scores /=45 over 5 infusions (approx. 5-7 months). Depending on domain, 14.7-27.3% of pts had initial PROMIS T-scores within 0.5SD of normal. There was a significant (p Conclusion Avoiding floor effects in pts who initiated TNFi therapy with near-normal PROMIS scores, PROMIS instruments demonstrated a robust T-score change in response to initiation of TNFi therapy. Disclosure of Interests Clifton Bingham Grant/research support from: BMS, Consultant for: AbbVie, BMS, Eli Lilly, Genentech/Roche, Janssen, Pfizer, Sanofi/Regeneron, Sergio Schwartzman Shareholder of: Amgen, Boston Scientific, Gilead, Medtronic, and Pfizer, Consultant for: AbbVie, Crescendo, Dermtech, Janssen, Gilead, Lilly, Myriad, Novartis, Regeneron, Samsung, Sanofi, and Union Chimique Belge, Speakers bureau: Abbott/AbbVie, Genentech, Janssen, Lilly, Novartis, Pfizer, Regeneron, Sanofi, and Union Chimique Belge, Shelly Kafka Shareholder of: J&J, Employee of: J&J, Dennis Parenti Employee of: Janssen Research & Development, LLC, Shawn Black Employee of: Janssen Research & Development, LLC, Stephen Xu Employee of: Employee of Janssen Research & Development, LLC, Wayne Langholff Employee of: Janssen Research & Development, LLC, Jeffrey Curtis: None declared

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 primary objective of AWARE is to assess the incidence of infusion reactions, the concomitant use of methotrexate (MTX) is also reported. The FDA approved label for GLM states that it is indicated for the treatment of patients with moderately to severely active RA in combination with MTX; however prospectively obtained real world evidence based data on the rate of GLM use without MTX has not been reported. Objectives Here we compare patient demographics, disease characteristics, response to therapy and discontinuation of GLM treated patients with and without concomitant MTX from an interim analysis (IA) of the AWARE study. Methods AWARE is a prospective, noninterventional, observational, multicenter 3-year study conducted in the US. RA pts (1,200 adults) were enrolled at the time of initiating treatment with GLM or IFX. All treatment decisions including MTX utilization are made at the discretion of the treating rheumatologist. Imputations of CDAI data were not performed at this IA. Data shown are mean ± standard deviation. Results 678 GLM pts were enrolled; of these 487 (71.8%) were GLM Plus-MTX and 191 (28.2%) were GLM No-MTX. Demographics are shown in the table. Response to therapy was assessed with CDAIs and shown in the figure below. Overall, 92.6% of GLM Plus-MTX and 91.5% of GLM No-MTX pts had a baseline (BL) categorical CDAI disease activity of moderate or high, and 7.4% of GLM Plus-MTX and 8.5% of GLM No-MTX pts had a BL categorical CDAI disease activity of low or remission. Discontinuation from the study during the period of this IA was similar between the GLM Plus-MTX (173/487; 35.5%) and GLM No-MTX (64/191; 33.5%). 7.9% of GLM No-MTX pts reported leflunomide use. Conclusion At BL 28.2% of pts on GLM did not report concomitant MTX use. The demographics of the GLM Plus-MTX pts did not differ remarkably from GLM No-MTX pts. The reported early response to treatment, assessed by CDAI score after 3 months and 6 months was similar in the GLM Plus-MTX and GLM No-MTX groups. These preliminary IA data suggest that in a real-world rheumatology practice setting, use of GLM with or without concomitant MTX led to similar CDAI scores at 3 and 6 months in RA pts with predominantly moderate to high BL CDAI disease category. Disclosure of Interests Aaron Broadwell Grant/research support from: Janssen Scientific Affairs, LLC, Vance Bray Grant/research support from: Janssen Scientific Affairs, LLC, Douglas Conaway Grant/research support from: Janssen Scientific Affairs, LLC, Joy Schechtman Grant/research support from: Janssen Scientific Affairs, LLC, Alan Kivitz Shareholder of: Novartis, Consultant for: Abbvie, Janssen, Pfizer, UCB, Genzyme, Sanofi, Regeneron, Boehringer Ingelheim, Sun Pharma Advanced Research, Flexion., Paid instructor for: Celgene, Horizon, Merck, Novartis, Pfizer, Genzyme, Sanofi, Regeneron, Speakers bureau: Celgene, Horizon, Merck and Genetech, Flexion, Dennis Parenti Employee of: Janssen Research & Development, LLC, Shawn Black Employee of: Janssen Research & Development, LLC, Stephen Xu Employee of: Employee of Janssen Research & Development, LLC, Wayne Langholff Employee of: Janssen Research & Development, LLC, Shelly Kafka Shareholder of: J&J, Employee of: J&J

Background Pt reported outcomes (PROs) play a role in disease evaluation, therapeutic assessment and care of RA pts. The Pt Reported Outcomes Measurement Information System (PROMIS [P]) questionnaires developed by NIH have been used in RA clinical practice and studies.Bartlett 2015 AWARE (Comparative and Pragmatic Study of Golimumab Intravenous [IV] Versus Infliximab in RA) is a noninterventional, multi-centre US-based, study of golimumab IV (GLM) vs. infliximab (IFX) in RA and will assess disease activity (DA) and use PROs. Objectives 1. PRO assessments of Pt response to treatment using PROMIS-29 Profile v2.0 (P29v2), P Pain Interference Short Form-6b (PISF) and P Fatigue Short Form-7a (FSF), and Clinical DA Index (CDAI), and 2. assess relationship between PROMIS T-score and CDAI category. Methods AWARE is a 1200 adult pt study enrolling pts on initiation of treatment w/GLM or IFX. We report an interim analysis (IA) of 747 pts’ baseline PROMIS questionnaire and CDAI scores. PROMIS results are normalised to the US population, reported as a “T-score” (mean=50, SD=10) w/higher scores indicating more of the trait measured. PROMIS T–scores were compared between High DA (HDA) w/Moderate DA (MDA), low DA (LDA) and remission. Data shown are mean ±SD. Statistical testing compared T-scores across CDAI categories using ANOVA for these data (before drug admin). Data from GLM and IFX pts are combined. Results Mean baseline CDAI score was 32.5±15.4, w/71.7% of pts in HDA, 22.5% in moderate MDA, 5.2% in LDA and 0.7% in remission. PROMIS T-scores were compared to 4 CDAI categories. HDA Pt T-scores were (*, p Conclusions Our interim findings demonstrate the feasibility of using PROMIS short forms and profiles to evaluate RA Pts in clinical trials. These results confirm the domain validity of PROMIS measures according to CDAI DA category. PROMIS measures show the range of impact across multiple domains of physical, emotional, and social health experienced by RA Pts. Disclosure of Interest J. Curtis Grant/research support from: Janssen Scientific Affairs, LLC, S. Schwartzman Grant/research support from: Janssen Scientific Affairs, LLC, S. Kafka Employee of: Janssen Scientific Affairs, LLC, D. Parenti Employee of: Janssen Scientific Affairs, LLC, S. Black Employee of: Janssen Scientific Affairs, LLC, S. Xu Employee of: Janssen Research and Development, LLC, W. Langholff Employee of: Janssen Research and Development, LLC, C. Bingham III Grant/research support from: Janssen Scientific Affairs, LLC

Objectives This retrospective healthcare claims analysis examined treatment patterns of innovator infliximab (IFX) and biosimilar infliximab (CT-P13) in a Turkish rheumatologic disease population after CT-P13 availability in July, 2014. Methods Adult patients (pts) with ≥1 diagnosis code (ICD-10-CM) for rheumatoid arthritis (RA) were identified in a national Turkish healthcare database during the study period (01DEC2010–01DEC2015). Eligible pts had continuous medical/pharmacy enrollment ≥12 months before and ≥6 months after IFX or CT-P13 initiation (index date). Patients were naive to IFX or CT-P13 (i.e. had no IFX or CT-P13 within 12 months before the index date). Demographics, concomitant diseases and medications, and treatment patterns, eg., dose, interval, discontinuation, and switch were summarized. Confirmed discontinuation was defined as a switch to another biologic medication or the absence of an index biologic claim for ≥120 days without censoring. Results Key results are shown in the Table. A total of 1044 patients initiated either medication. The majority (80%; n=831) initiated IFX. The IFX cohort had a mean age of 42 years; 56% were women and mean follow up was 12 months. The CT-P13 cohort consisted of 213 pts with mean age of 43 years; 58% women; and mean follow up of 9 months. Approximately one-third of pts in each cohort had a concomitant diagnosis of ankylosing spondylitis (AS; TABLE). Other concomitant diseases and medications appeared balanced between cohorts. Pts in the IFX cohort had an average of 5.2 infusions and mean dose of 4.7 vials per infusion approximately every 8 weeks. Pts in the CT-P13 cohort had an average of 3.6 doses and mean dose of 5.8 vials per dispensing approximately 9 weeks apart. A confirmed discontinuation occurred in 55% of the IFX cohort; driven in part by switching. 24% of IFX pts had ≥1 biologic switch with 8% initially switching to CT-P13. Time to any discontinuation or censoring of IFX is shown in the Table. In the CT-P13 cohort, a confirmed discontinuation was observed in 63%; 31% switched to another biologic therapy; and 20% initially switched to IFX. Time to any discontinuation or censoring of CT-P13 is shown in the Table. Conclusions These findings in a single country indicate that real world utilization patterns may differ between innovator IFX and CT-P13, with predominantly more patients initiating IFX; greater overall CT-P13 discontinuation and a higher proportion of patients switching from CT-P13 to IFX. Further studies are needed to understand the reasons for these observed differences. Disclosure of Interest Y. Yazici Grant/research support from: Janssen Scientific Affairs, LLC, L. Xie Consultant for: Janssen Scientific Affairs, LLC, A. Ogbomo Consultant for: Janssen Scientific Affairs, LLC, D. Parenti Employee of: Janssen Scientific Affairs, LLC, K. Goyal Employee of: Janssen Scientific Affairs, LLC, A. Teeple Employee of: Janssen Scientific Affairs, LLC, L. Ellis Employee of: Janssen Scientific Affairs, LLC, I. Simsek Grant/research support from: Janssen Scientific Affairs, LLC

Objectives This study examined treatment patterns in a rheumatology patient (pt) population initially prescribed innovator infliximab (IFX) that either switched to biosimilar infliximab (CT-P13) or continued on IFX following availability of CT-P13 in the Turkish healthcare system. Methods Adult pts with ≥1 diagnosis code (ICD-10-CM M05.X; M06.X) for rheumatoid arthritis (RA) and a prescription for IFX were identified in a national Turkish health care database during the study period (01DEC2010–01DEC2015). Eligible pts were those who continued on IFX (Continuers cohort; CC) or switched from IFX to CT-P13 (Switchers cohort; SC) during the identification period; had continuous medical/pharmacy benefit enrollment ≥12 months before and ≥6 months after the index date (date of switch for SC and a random IFX prescription date for CC); had a prescription claim for IFX within 16 weeks of the index date during the baseline period. Demographics, concomitant disease, medications, and treatment patterns (dose, refill interval, discontinuation, and switch) were summarized. A confirmed discontinuation was defined as a switch to another biologic medication or the absence of an index biologic claim for ≥120 days without censoring. Patient weight was unavailable in the dataset. Results Key results are shown in the Table. A total of 3018 pts met study criteria. The majority (95%; n=2870; CC) continued on IFX and had a mean age of 44 years; 46% were female and mean follow up of 12 months. A total of 148 pts (5%) switched to CT-P13 (SC) and had mean age of 44 years; 51% female and mean follow up of 9 months. Approximately 40% of pts in each cohort had a concomitant diagnosis for ankylosing spondylitis (AS; Table). Other concomitant diseases and medications appeared balanced between cohorts. In the CC, pts had an average of 4.7 infusions at a mean dose of 4.4 vials approximately every 10 weeks. In the SC, pts had an average of 2.6 infusions at a mean dose of 3.6 vials approximately every 10 weeks. Therapy discontinuation occurred in 38% in the CC; average time to any discontinuation or censoring of IFX was 256 days (Table). In the SC, CT-P13 discontinuation was observed in 82%; average time to any discontinuation or censoring of CT-P13 was 124 days; 74% of SC switched to another biologic with 94% of these returning to IFX. Conclusions This study shows switching from IFX to CT-P13 was infrequent. However, in those switching to CT-P13, a high percentage (82%) of CT-P13 discontinuation was observed and the majority returned to IFX. Further studies are needed to understand the reasons for these observations. Disclosure of Interest Y. Yazici Grant/research support from: Janssen Scientific Affairs, LLC, L. Xie Consultant for: Janssen Scientific Affairs, LLC, A. Ogbomo Consultant for: Janssen Scientific Affairs, LLC, D. Parenti Employee of: Janssen Scientific Affairs, LLC, K. Goyal Employee of: Janssen Scientific Affairs, LLC, A. Teeple Employee of: Janssen Scientific Affairs, LLC, L. Ellis Employee of: Janssen Scientific Affairs, LLC, I. Simsek Grant/research support from: Janssen Scientific Affairs, LLC

Background Patient (Pt) reported outcomes (PROs) play a role in overall disease evaluation, therapeutic response assessment and care of rheumatoid arthritis (RA) patients (Pts). The Pt Reported Outcomes Measurement Information System (PROMIS [P]) questionnaires developed by the NIH have been validated and are a feasible assessment tool in RA (Bartlett 2015). Objectives AWARE (Comparative and Pragmatic Study of Golimumab Intravenous (IV) Versus Infliximab in RA) is a real-world study of golimumab IV (G-IV) vs. infliximab (IFX) in RA and will assess infusion reactions, disease activity and multiple PROs as outcomes measures. Methods AWARE is a prospective, noninterventional, ongoing US-based study in which 1,200 adult Pts will be enrolled on initiation of treatment with G-IV or IFX. Objectives include PRO assessments of Pt response to treatment using the PROMIS-29 Profile v2.0 (P29v2), P Pain Interference Short Form-6b (PISF) and P Fatigue Short Form-7a (FSF), 36-Item Short Form Health Survey (SF-36v2) and the Clinical Disease Activity Index (CDAI). We report an interim analysis from the first 353 Pts of baseline PROMIS questionnaire and CDAI scores, and their inter-relationships. PROMIS questionnaire results are scored on a 0 to 100 scale, normed to the US population and reported as a “T-score” (mean of 50 and standard deviation (SD) of 10). PROMIS T scores were compared across CDAI disease activity (DA) categories. Results Baseline mean (SD) CDAI score was 33.46 (±15.79), with 73.4% of pts with high DA (HDA), 22.1% with moderate disease activity (MDA), 3.7% with low disease activity (LDA) and 0.8% pts in remission. PROMIS scores are shown below. All P29v2 domains, PISF and FSF scores were significantly worse in pts with CDAI>22 vs. CDAI≤22 (p Conclusions These interim data further support the viability of using PROMIS questionnaires to evaluate RA pts, and indicate in this predominantly HDA population of RA pts correlations between PROMIS and CDAI disease activity category. Confirmation of the baseline interim analysis findings with the fully enrolled AWARE study, as well as inclusion of longitudinal and subset analyses based on disease activity levels, will further define the role of PROMIS relative to CDAI in RA patients in a real world setting. Disclosure of Interest J. Curtis Consultant for: Janssen, AbbVie, Roche/Genentech, BMS, UCB, Myriad, Lilly, Amgen, Pfizer, Corrona, S. Kafka Employee of: Janssen Scientific Affairs, LLC, D. Parenti Employee of: Janssen Scientific Affairs, LLC, S. Black Employee of: Janssen Scientific Affairs, LLC, S. Xu Employee of: Janssen Research & Development, LLC, Y. Wang Employee of: Janssen Research & Development, LLC, C. Bingham III Grant/research support from: Janssen, PCORI, NIH, Pfizer, Consultant for: Janssen, AbbVie, Amgen, BMS, Celgene, Genentech/Roche, Lilly, Macrogenics, Meoblast, Novartis, NovoNordisk, Pfizer, Regeneron, UCB

Background Clinical studies demonstrated that baseline disease activity including C-reactive protein (CRP) level was a predictor variable for radiographic joint damage in patients with rheumatoid arthritis (RA). Objectives To identify variables associated with radiographic joint damage in patients with RA treated with intravenously administered golimumab (GLM) + Methotrexate (MTX) or MTX + placebo (PBO). Methods GO-FURTHER was a multicenter, randomized, placebo-controlled study. Adult patients with active RA despite MTX therapy (≥6 tender and swollen joints, CRP ≥1.0 mg/dL, and RF and/or anti-CCP positive) were randomized to placebo (PBO) + MTX or GLM (2mg/kg) plus MTX at week 0, 2, and every 8 week thereafter (GLM group). Patients in PBO group with Sharp score (TSS). The correlations of TSS with hemoglobin, disease activity score (DAS28-CRP)and physical function evaluated with Health Assessment Questionnaire (HAQ) were assessed using Spearman9s correlation or multivariable liner regression model. Anemia was defined based on World Health Organization (WHO) criteria as Hgb Results Moderate to severe RA was demonstrated by a mean DAS28 score of 5.9 with TSS of 48.5 in all patients group at baseline. In linear regression models, baseline DAS28, HAQ score, and Hgb level was correlated with baseline TSS with Spearman9s correlation coefficient (r) of 0.148 (p Conclusions Hemoglobin level is an independent variable predicting radiographic progression in MTX refractory RA patients. Disclosure of Interest R. Westhovens Grant/research support from: Janssen R & D, LLC, C. Han Employee of: Johnson & Johnson Pharmaceutical Services, LLC, M. Weinblatt Grant/research support from: Janssen R & D, LLC, L. Kim Employee of: Janssen R & D, LLC, E. Hsia Employee of: Janssen R & D, LLC, D. Parenti Employee of: Janssen Scientific Affairs, LLC, S. Kafka Employee of: Janssen Scientific Affairs, LLC, C. Bingham III Grant/research support from: Janssen R & D, LLC

Background Little is known about the influence of specific comorbidities on response to biologic therapy. Objectives To examine the impact of comorbidities on anti-TNF therapy efficacy in rheumatoid arthritis (RA) patients (pts) within the US CORRONA RA registry. Methods A retrospective cohort of adult RA pts with moderate-to-severe RA (CDAI>10) who initiated anti-TNF biologics after June 1, 2009 and had a 6 month follow up (in a window of 3–9 months) were included. Comorbidity assessments included a modified Charlson comorbidity index (CCI) [HIV status was not assessed]) and diagnoses of diabetes, cardiovascular disease (CV) and history of depression. Propensity score (PS) method was employed to match pts with and without select comorbidities. Variables used for PS matching were selected if standardized differences were ≥0.1 between groups. PS were stratified by line of therapy. The primary outcome was achievement of low disease activity (LDA) at 6 months (CDAI ≤10). Secondary outcomes included DAS28(ESR) LDA (DAS Results A total of 4064 anti-TNF initiations were included. For CCI, diabetes and CV, there were no significant differences in response in the matched populations. For patients with a history of reported depression (hxdep), LDA rates were significantly lower (29% for hxdep vs 39% for no hxdep, p Conclusions Of the comorbidities examined, a history of reported depression in RA patients is an indicator of lower response rates to TNFi. CDAI was primarily influenced by patient responses. Patient fatigue may be a manifestation of depression and explained response rate differences. Further analyses are needed to explore this relationship. Acknowledgement This study is sponsored by Corrona, LLC. The Corrona RA registry has been supported through contracted subscriptions in the last two years by AbbVie, Amgen, BMS, Crescendo, Genentech, Horizon Pharma USA, Janssen, Eli Lilly, Novartis, Pfizer, and UCB. Disclosure of Interest D. Parenti Employee of: Janssen Scientific Affairs, LLC, G. Reed Shareholder of: Corrona, LLC, Employee of: Corrona, LLC, S. Kafka Employee of: Janssen Scientific Affairs, LLC, L. Ellis Employee of: Janssen Scientific Affairs, LLC, J. Greenberg Shareholder of: Corrona, LLC, Consultant for: Janssen Scientific Affairs, LLC, AstraZeneca, Celgene, Genentech, Novartis, Pfizer, Employee of: Corrona, LLC, R. DeHoratius Employee of: Janssen Scientific Affairs, LLC

Background Clinical studies demonstrated that patients with rheumatoid arthritis (RA) experience lower hemoglobin level and higher prevalence of anemia than general population. Objectives This study was to examine the treatment effect of intravenously administered golimumab on improving hemoglobin (Hgb) level, and relieving anemia and anemia-related outcomes among patients with RA using data from the phase III clinical trial GO-FURTHER. Methods In the GO-FURTHER trial, adult patients with active RA were randomized to placebo + MTX (PBO group) or GLM (2mg/kg) plus MTX at week 0, 2, and every 8 weeks thereafter (GLM group). Patients in placebo group with Results At baseline, mean (SD) of Hgb was 12.1 (1.39) g/dl in female and 13.8 (1.29) g/dl in male, and 40.8% female patients and 23.4% male patients had anemia. Significantly greater improvement in hemoglobin in the GLM-treated patients than patients in the placebo group was observed as early as Week 4. At Week 12, mean improvement in Hgb was 0.34g/dl in male and 0.69g/dl in female in the GLM group, compared to an improvement of 0.01g/dl in male (p Conclusions Intravenously administered golimumab therapy improves Hgb, resulting in reduced anemia, improved physical function and fatigue in patients with moderate to severe active RA despite MTX. Disclosure of Interest C. Han Employee of: Johnson & Johnson Pharmaceutical Services, M. Weinblatt Grant/research support from: Janssen R & D, LLC, R. Westhovens Grant/research support from: Janssen R & D, LLC, L. Kim Employee of: Janssen R & D, LLC, E. Hsia Employee of: Janssen R & D, LLC, D. Parenti Employee of: Janssen Scientific Affairs, LLC, S. Kafka Employee of: Janssen Scientific Affairs, LLC, C. Bingham III Grant/research support from: Janssen R & D, LLC

Background Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for the management of pain associated with rheumatoid arthritis and osteoarthritis. As a class, NSAIDs are associated with dose-related serious gastrointestinal, cardiovascular, and renal adverse events (AEs), prompting the European Medicines Agency, the US Food and Drug Administration, and others to recommend that NSAIDs be used at the lowest effective dose for the shortest possible duration. 1 To deliver effective pain relief with lower systemic exposure than commercially available drug products, Iroko Pharmaceuticals is developing investigational, lower-dose SoluMatrix® meloxicam manufactured using SoluMatrix Fine Particle Technology™ and containing submicron particles of meloxicam with enhanced dissolution properties. Objectives To evaluate the pharmacokinetic (PK) properties and safety of lower-dose submicron meloxicam in healthy adult volunteers. Methods In this 4-period, 4-sequence crossover study, healthy adults aged 18 to 55 years were randomized to receive single doses of lower-dose submicron meloxicam 5 mg (under fasted conditions), lower-dose submicron meloxicam 10 mg (under fasted and fed conditions), and conventional meloxicam 15-mg tablets (Mobic®); Boehringer Ingelheim; under fasted conditions). Blood samples for PK assessment were collected pre dose through 96 h post dose and were analyzed using a validated LC-MS/MS method. Safety was also evaluated. Results Twenty-eight participants were enrolled and 25 participants completed the study. Lower-dose submicron meloxicam 10 mg (1.25±0.25 μg/mL) attained similar mean peak plasma meloxicam levels ± SD compared with conventional meloxicam 15-mg tablets (1.29±0.42 μg/mL; Table) under fasting conditions. Lower-dose submicron meloxicam 5 mg (2.0 h) and 10 mg (2.0 h) achieved more rapid time to peak plasma meloxicam levels under fasting conditions compared with conventional meloxicam 15-mg tablets (4.0 h). Lower-dose submicron meloxicam 10 mg demonstrated approximately 29% lower overall systemic exposure compared with conventional meloxicam 15-mg tablets (Table). As described for other NSAIDs, food decreased the rate but not the overall extent of meloxicam absorption from lower-dose submicron meloxicam (Table). Lower-dose submicron meloxicam 5 and 10 mg and conventional meloxicam 15-mg tablets demonstrated similar drug clearance based on half-life and the terminal elimination rate constant (Table). Treatment-related AEs included 1 case each of mild abdominal pain and mild diarrhea in the lower-dose submicron meloxicam 10 mg (fed) group and 1 report of mild somnolence in the lower-dose submicron meloxicam 5 mg group. Conclusions Lower-dose submicron meloxicam 10 mg demonstrated comparable peak plasma levels, earlier time to peak plasma levels, and lower overall systemic exposure compared with conventional meloxicam 15-mg tablets under fasting conditions. Trials are underway to assess the clinical impact of this investigational, lower-dose meloxicam drug product. References McCarberg BH, et al. Clin Ther. 2012;34(9):1954-1963. Disclosure of Interest K. Olugemo Employee of: PAREXEL, D. Parenti Employee of: Iroko Pharmaceuticals, LLC, C. Young Employee of: Iroko Pharmaceuticals, LLC DOI 10.1136/annrheumdis-2014-eular.5403