M. Shawi

Use of corticosteroids in patients with rheumatoid arthritis treated with infliximab: treatment implications based on a real-world Canadian population.

Objective To describe the rate of concomitant oral corticosteroid use at antitumour necrosis factor (TNF) initiation and at disease remission, and to assess its effect on incidence of infection and sustainability of remission among patients with rheumatoid arthritis (RA) treated with infliximab in Canadian routine care. Methods Biological naïve patients with RA followed in the Biologic Treatment Registry Across Canada (BioTRAC) were included. The time-dependent association between corticosteroid dose (no use, ≤5 mg/day, >5 mg/day) and the incidence of first infection, while considering possible confounders, remission sustainability and the incidence of subsequent infections were assessed with Cox regression. Results 838 patients were included; mean (SD) baseline age and disease duration were 55.6 (13.5) and 10.5 (9.8) years, respectively. After a mean (SD) of 51.3 (43.6) months, the total incidence of adverse events (AEs) and infections were 110.2 and 19.6 per 100 person-years (PY), respectively. In multivariate analysis, the HR (95% CI) for acquiring an infection was 2.48 (1.24 to 4.98) with >5 mg/day of corticosteroids versus no corticosteroids. Similarly, ≤5 mg/day of corticosteroids was associated with increased hazard for infection (2.12 (0.97 to 4.66)). Despite DAS28 (disease activity score 28) or Clinical Disease Activity Index (CDAI) remission, corticosteroids were continued in 16.4% and 16.7% of cases, respectively. Continued corticosteroid treatment was not associated with sustainability of remission (HRDAS28 (95% CI) 1.40 (0.95 to 2.06); HRCDAI 1.19 (0.75 to 1.88)), however, it had a significant impact on development of infection (HRDAS28 (95% CI) 1.78 (1.00 to 3.19); HRCDAI 2.38 (1.14 to 4.99)). Conclusions Oral corticosteroid treatment was associated with increased risk of development of infection without impacting sustainability of remission. These results support the notion that corticosteroids should be used concomitantly with anti-TNF for the shortest period possible to achieve remission, and then tapered. Trial registration number NCT00741793.

Effectiveness and Safety of Infliximab in Rheumatoid Arthritis: Analysis From a Canadian Multicenter Prospective Observational Registry

To describe the profile of rheumatoid arthritis (RA) patients treated with infliximab in Canadian routine care and to assess the real‐world effectiveness and safety of infliximab.

Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis.

Objectives To describe the profile of patients with ankylosing spondylitis (AS) treated with infliximab in Canadian routine care and to assess the effectiveness and safety of infliximab in real world. Setting 46 primary care rheumatology practices across Canada. Participants 303 biological-naïve patients with AS or patients previously treated with a biological for <6 months and who were eligible for infliximab treatment as per routine care within the Biologic Treatment Registry Across Canada (BioTRAC). Intervention Not applicable (non-interventional study). Primary and secondary outcomes Effectiveness was assessed with changes in disease parameters (AS Disease Activity Score (ASDAS), Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), Health Assessment Questionnaire Disease Index (HAQ-DI), physician global assessment of disease activity (MDGA), patient global disease activity (PtGA), back pain, C-reactive protein, erythrocyte sedimentation rate (ESR), morning stiffness). Safety was assessed with the incidence of adverse events (AEs). Results Of the 303 patients included, 44.6% were enrolled in 2005–2007 and 55.4% in 2008–2013. Patients enrolled in 2005–2007 had significantly higher MDGA and ESR at baseline while all other disease parameters examined were numerically higher with the exception of PtGA. Treatment with infliximab significantly (p<0.001) improved all disease parameters over time in both groups. At 6 months, 56% and 31% of patients achieved clinically important (change≥1.1) and major (change≥2.0) improvement in ASDAS, respectively; at 48 months, these proportions increased to 75% and 50%, respectively. Among patients unemployed due to disability at baseline, 12.1% returned to work (mean Kaplan-Meier (KM)-based time=38.8 months). The estimated retention rate at 12 and 24 months was 78.3% and 60.1%, respectively. The profile and incidence of AEs were comparable to data previously reported for tumour necrosis factor-α inhibitors. Conclusions Characteristics of patients with AS at infliximab initiation changed over time towards lower disease activity and shorter disease duration. Infliximab treatment significantly reduced disease activity independent of treatment initiation year, although patients enrolled in recent years achieved lower disease activity over 48 months. Trial registration number NCT00741793.

THU0365 Do Patterns of Joint Swelling or Tenderness in Rheumatoid Arthritis Patients Impact Disease Activity Outcomes and Pain? Implications for Clinical Practice

Objectives This analysis aimed to describe the pattern of specific joint involvement (tender and/or swollen) pre- and post-TNFi treatment and the impact of specific joint pattern involvement on composite score outcomes and pain. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with infliximab (IFX) or golimumab (GLM). In this analysis, RA patients included those treated with IFX between 2002-2014 or with GLM between 2010-2014. Based on joint involvement 7 groups were created: shoulder(s), elbow(s), metacarpophalangeal (MCP(s)), wrist(s), proximal interphalangeal (PIP(s)), knee(s), and thumb(s). The impact of specific joints on disease activity indices and pain was assessed with the independent-samples t-test; linear regression produced adjusted estimates. Results A total of 1030 RA patients were included with 5177 assessments. At baseline, MCP(s) (84.8%) and wrist(s) (66.1%) were the most commonly swollen joints. Tenderness was most frequent at baseline in these two joint types (81.1% and 70.9% of patients, respectively). Swelling/tenderness rates in all joint groups were significantly lower (p<0.001) among patients enrolled in 2010-2013 vs. those enrolled in 2002-2005; no significant differences, however, were observed in joint involvement pattern. Swelling and tenderness in all joint groups were associated with significantly (P<0.001) higher pain. Upon adjusting for age, gender and the total number of swollen (SJC28) or tender (TJC28) joints, swollen shoulder(s) and knee(s), and tender shoulder(s) and elbow(s) had the biggest impact on pain. Swollen MCP(s), knee(s) and thumb(s) had the greatest impact on DAS28, while for CDAI and SDAI swollen thumb(s) and swollen thumb(s) and knee(s), respectively, showed the highest association. Tender wrist(s), shoulder(s), and knee(s) showed the highest association with DAS28, while tender MCP(s) had the greatest impact on CDAI and SDAI. However, all indices were significantly higher among cases with swollen thumb(s) (unstandardized coefficient (B): BDAS28=0.25, P=0.006; BCDAI=2.09, P=0.001; BSDAI=2.66, P=0.001). Conclusions Although joint swelling/tenderness documented at anti-TNF initiation has decreased over time, the profile of affected joints has remained stable. Swelling/tenderness in specific joint groups was differentially associated with pain, with larger joints having the greatest impact. Furthermore, differences were observed in levels of disease activity based on the type of affected joint which could be attributed to their impact on patient global assessment. These results suggest that location of joint involvement, in addition to the number of affected joints, has an independent impact on pain. Disclosure of Interest R. Arendse Consultant for: Janssen, J. Kelsall Consultant for: Janssen, A. Avina-Zubieta Consultant for: Janssen, P. Baer Consultant for: Janssen, J. Rodrigues Consultant for: Janssen, A. Jovaisas Consultant for: Janssen, I. Fortin Consultant for: Janssen, M. Sheriff Consultant for: Janssen, M. Khraishi Consultant for: Janssen, E. Rampakakis: None declared, J. Sampalis: None declared, F. Nantel Employee of: Janssen, M. Shawi Employee of: Janssen, C. Tkaczyk Employee of: Janssen, S. Otawa Employee of: Janssen, A. Lehman Employee of: Janssen

SAT0062 What is the Effect of TNF Inhibitors on Employment Status in Rheumatoid Arthritis Patients and what are the Predictors of Progression to Unemployment

Objectives The aim of this analysis was to evaluate the prevalence of unemployment due to work disability in RA patients initiating treatment with infliximab (IFX) or golimumab (GLM) and to identify determinants of disability. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with IFX or GLM as first biologics. Data were obtained from RA patients treated with IFX (2002-2014) or GLM (2010-2014). Between employment group differences were assessed for statistical significance with the independent samples t-test or the chi-square. Time to employment and time to unemployment were assessed with the Kaplan-Meier (KM) estimator of the survival function. Cox regression was used to identify predictors of time to unemployment. Results A total of 581 RA patients were included; 374 (64.4%) employed and 207 (35.6%) unemployed due to disability. The following baseline parameters were associated with significantly increased likelihood of being unemployed due to disability: female vs. male gender (40.1% vs. 27.6%; P=0.006), earlier enrolment period (2002-05 vs. 2006-09 vs. 2010-14: 49.3% vs. 30.5% vs. 22.4%; P<0.001), insurance type (provincial vs. private vs. both: 54.9% vs. 23.8% vs. 20.0%; P<0.001), older age (P=0.033), and increased disease activity as evidenced by the higher DAS28 (P<0.001), SJC (P<0.001), TJC (P<0.001), HAQ (P<0.001), MDGA (P<0.001), PtGA (P<0.001), CDAI (P<0.001), SDAI (P<0.001), pain (P<0.001), and ESR (P<0.001). Among disabled patients, 10.1% were able to return to work upon treatment with TNF a mean KM-based duration of 119.5 months from baseline; whereas 6.4% of employed patients became disabled (2002-05 vs. 2006-09 vs. 2010-14: 7.0% vs. 10.1% vs. 1.7%; P=0.021) with a mean time to unemployment of 113.4 months. Multivariate survival analysis showed that, upon adjusting for enrolment period, higher baseline HAQ [HR (95%CI): 3.59 (1.64, 7.87), P=0.001], and higher baseline SJC [HR (95%CI): 1.09 (1.02, 1.16), P=0.011] were significant predictors of unemployment due to disability. Conclusions A significant proportion of RA patients are unemployed due to disability. At anti-TNF initiation, work disability was associated with higher disease activity, female gender, earlier enrolment period, and provincial insurance. Increased HAQ and higher SJC were significant predictors of progression to unemployment. Anti-TNF treatment was effective in enabling a considerable portion of disabled patients to return to employment. Disclosure of Interest A. Chow: None declared, W. Bensen Consultant for: Janssen, R. Arendse Consultant for: Janssen, E. Keystone Consultant for: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, P. Baer Consultant for: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, J. Kelsall Consultant for: Janssen, W. Olszynski: None declared, J. Rodrigues: None declared, A. Avina-Zubieta: None declared, M. Baker: None declared, W. Olszynski: None declared, W. Bensen Consultant for: Janssen, P. Baer Consultant for: Janssen, D. Choquette Consultant for: AbbVie, Amgen, Celgene, BMS Canada, Janssen, Pfizer, S. Kapur: None declared, A. Jaroszynska: None declared, J. Sampalis Shareholder of: JSS Medical Research, Employee of: JSS Medical Research, D. Choquette Consultant for: AbbVie, Amgen, Celgene, BMS Canada, Janssen, Pfizer, E. Rampakakis Employee of: JSS Medical Research, S. Kapur: None declared, J. Stewart: None declared, C. Tkaczyk Employee of: Janssen, J. Sampalis Shareholder of: JSS Medical Research, Employee of: JSS Medical Research, M. Shawi Employee of: Janssen, E. Rampakakis Employee of: JSS Medical Research, A. Lehman Employee of: Janssen, F. Nantel Employee of: Janssen, S. Otawa Employee of: Janssen, C. Tkaczyk Employee of: Janssen, A. Lehman Employee of: Janssen

SAT0090 Exploring The Das: What is the Level of Agreement in the Classification of Remission and Low Disease Activity Among the Various Versions of the Disease Activity Score (DAS) and Their Correlation? An Analysis from a Prospective, Observational Registry

Background Two versions of DAS28 are available, DAS28-4 comprising 4 variables [tender and swollen joint counts, acute phase reactant (APR), and patient global assessment] and DAS28-3 where patient global has been omitted. Despite the difference between DAS28-4 and DAS28-3 thresholds for remission and low disease activity (LDA) are the same. The APR used to calculate DAS may be either ESR or CRP. Objectives This analysis describes the agreement between these four possible indices, DAS28-4-ESR, DAS28-4-CRP, DAS28-3-ESR and DAS28-3-CRP and compares them in terms of classifying remission and LDA in a real-world, routine clinical care setting. Methods BioTRAC is a prospective registry of patients initiating treatment with infliximab or golimumab. In this analysis, data from RA patients who were treated with infliximab between 2002-2014 or with golimumab between 2010-2014 and had available information in all indices were used. The definitions for remission were: DAS28-3/4 <2.6; LDA was defined as: DAS28-3/4 <3.2. Correlation between different indices was assessed with Pearsons correlation coefficient (r) and classification agreement was assessed with Cronbachs alpha (CA) and the kappa statistic. Results 869 RA patients who had 3,517 complete assessments were included in the analysis. Non-remission was classified by all indices in 61.4% of cases, while remission was achieved in one (5.9%), two (10.3%), three (5.3%), or all four (17.2%) indices. Similarly, non-LDA was classified by all indices in 46.1% of cases, while LDA was achieved in one (6.2%), two (10.9%), three (5.4%), or all four (31.3%) indices. Overall, a strong linear positive correlation (r>0.8) was observed between all indices. When looking at the internal consistency in terms of classifying disease state, the CA was 0.905 for remission and 0.923 for LDA suggesting an overall high internal consistency. However, when looking at individual inter-item correlations, agreement between indices was variable with DAS28-3CRP and DAS28-4CRP showing highest correlation and DAS28-3-ESR and DAS28-4-CRP showing lowest correlation. When comparing DAS28-4-ESR with DAS28-3-ESR, the latter categorized 16.5% of DAS28-4-ESR remission cases as non-remission and 3.0% of DAS28-4-ESR non-remission cases as remission. With respect to LDA, DAS28-3-ESR categorized 9.1% of DAS28-4-ESR LDA cases as non-LDA and 4.7% of DAS28-4-ESR non-LDA cases as LDA. Similar results were observed with DAS28CRP. Conclusions The results of this analysis show that, despite being highly correlated, variability exists in the classification of remission and LDA by the various DAS indices. Decision making based on disease state achieved may vary significantly based on type of APR used in the DAS index. Disclosure of Interest W. Bensen Consultant for: Janssen, E. Keystone Consultant for: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, P. Baer Consultant for: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, J. Rodrigues: None declared, A. Avina-Zubieta: None declared, W. Olszynski: None declared, D. Choquette Consultant for: AbbVie, Amgen, Celgene, BMS Canada, Janssen, Pfizer, S. Kapur: None declared, J. Sampalis Shareholder of: JSS Medical Research, Employee of: JSS Medical Research, E. Rampakakis Employee of: JSS Medical Research, C. Tkaczyk Employee of: Janssen, M. Shawi Employee of: Janssen, A. Lehman Employee of: Janssen, F. Nantel Employee of: Janssen, S. Otawa Employee of: Janssen

THU0196 Is the Basdai Score Driven by Pain in Ankylosing Spondylitis Patients Treated with Anti-TNF?

Background The present standard for measuring disease activity in Ankylosing Spondylitis (AS) is the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) which focuses on five major symptoms including fatigue, axial pain, peripheral pain, enthesitis and morning stiffness (severity and duration). Objectives Given that the BASDAI instrument contains two pain questions, the objective was to assess whether pain symptoms are the main drivers of BASDAI scores among AS patients treated with anti-TNFs in routine clinical practice. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with infliximab (IFX) or golimumab (GLM). Patients with AS treated with IFX or GLM and enrolled between 2005 and 2014 were included in this analysis. A modified weighted BASDAI score (m-BASDAI) was calculated excluding the axial (Q2) and peripheral (Q3) pain questions of the BASDAI. The correlation of BASDAI, each of its components, and the modified BASDAI (m-BASDAI) was assessed with the Pearson correlation coefficient. BASDAI low disease activity (LDA) and m-BASDAI LDA were defined as a score ≤3. The association between the number of administered analgesics (0, 1, >1) and BASDAI/m-BASDAI was assessed with one-way ANOVA. Results A total of 413 AS patients with 1,709 assessments were included in this analysis. Correlation analysis showed a strong correlation between the full BASDAI and m-BASDAI scores (r=0.98, P<0.001). With respect to the individual BASDAI questions, a strong positive linear correlation was observed between all questions and the BASDAI score as well as the m-BASDAI score. As expected, a lower correlation was observed between Q2 and Q3 with the m-BASDAI relative to BASDAI. Axial pain was most strongly correlated with the severity of morning stiffness, whereas the highest correlation of peripheral pain was observed with localized tenderness. The cross-tabulation of BASDAI LDA and m-BASDAI LDA showed a strong measure of agreement (kappa=0.871, P<0.001). Omission of the pain questions from BASDAI resulted in a comparable proportion of LDA cases (41.7% vs. 40.9%) when using the same LDA definition. Increased use of analgesics (0 vs. 1 vs. >1) over 2 years of follow-up was associated with significantly (P<0.05) higher mean scores in BASDAI, m-BASDAI, and each of the BASDAI components. No significant association was observed between increased use of analgesics and treatment retention. Conclusions Higher levels of AS pain are significantly associated with a higher BASDAI score and increased use of analgesic medications among patients treated with anti-TNFs. In addition to pain, fatigue, tenderness, and morning stiffness are likewise important contributing components in the BASDAI score and the disease burden of AS. Disclosure of Interest P. Rahman Consultant for: Abbott, AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer, Roche, A. Jovaisas: None declared, W. Bensen Consultant for: Janssen, W. Olszynski: None declared, A. Jaroszynska: None declared, P. Baer Consultant for: AbbVie, Amgen,BMS, Janssen, Pfizer, Roche, M. Sheriff: None declared, D. Sholter: None declared, E. Psaradellis Employee of: JSS Medical Research, J. Sampalis Shareholder of: JSS Medical Research, F. Nantel Employee of: Janssen, S. Otawa Employee of: Janssen, A. Lehman Employee of: Janssen, C. Tkaczyk Employee of: Janssen, M. Shawi Employee of: Janssen

SAT0565 Correlation of Individual HAQ Questions with Disease Activity Measures in Psoriatic Arthritis: Implications for Instrument Reduction

Background The Health Assessment Questionnaire (HAQ) is commonly used for assessing patient-reported functional status and disease activity in psoriatic arthritis (PsA). However, it has been critiqued for being time-consuming, not easily scored and thus, not contributing to decisions in routine care (1) Objectives The aim of this analysis was to describe the correlation of individual HAQ questions with patient and physician reported measures used in PsA and to examine whether the instrument could be reduced to better reflect routine clinical practice. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with infliximab or golimumab. Data from PsA patients treated with infliximab or golimumab in 2006-2013 were used. The correlation of each HAQ question with patient and physician (pain, patient global assessment (PtGA), SJC28, TJC28 and physician global assessment (MDGA)) reported measures were described with the Pearsons correlation coefficient. The impact of each HAQ question on the need for help in each HAQ domain was assessed with logistic regression. Factor analysis was used to assess the variability due to each question in HAQ. Results A total of 183 PsA patients with 596 HAQ assessments were included. Individual HAQ questions correlated at different extents with each PsA measures. All questions showed higher correlations with PtGA and pain compared to MDGA. Regarding patient reported outcomes, Question 5A (“Wash/dry your entire body”) showed the highest correlation, specifically with pain. The majority of HAQ questions were significantly associated with the need for help within their corresponding ability category, with the exception of questions Q3B, Q3C, Q4B, Q5C and Q8B. The results of factor analysis showed that 2 (Q1A and Q3B) out of the 20 HAQ questions accounted for 61.5% of its matrix variance, suggesting that the question on the ability to “dress, tie shoelaces and do buttons”, as well as the question on the ability to “lift a full cup or glass” may be the main drivers of HAQ in PsA. Conclusions Variability exists in the correlation of individual HAQ questions with patient and physician reported PsA measures. Pain and PtGA are significantly associated with the various domains of HAQ, while clinical outcomes (SJC28 and TJC28) and MDGA are less important. Among PsA patients, the HAQ is driven by components related to dressing and grooming and to eating abilities, suggesting that PsA patients may be facing different challenges than RA patients. This may have implications from an occupational health perspective and in the design of a shorter self-report instrument more suitable for PsA patients. References Khanna D, et al. Arthritis Care Res. 2011;63:S486-S490. Disclosure of Interest D. Choquette Consultant for: AbbVie, Amgen, Celgene, BMS Canada, Janssen, Pfizer, C. Thorne: None declared, M. Khraishi: None declared, I. Fortin: None declared, R. Arendse: None declared, A. Chow: None declared, J. Kelsall Consultant for: Janssen, M. Baker: None declared, J. Vaillancourt Employee of: JSS Medical Research, J. Sampalis Shareholder of: JSS Medical Research, F. Nantel Employee of: Janssen, S. Otawa Employee of: Janssen, A. Lehman Employee of: Janssen, C. Tkaczyk Employee of: Janssen, M. Shawi Employee of: Janssen

FRI0036 What is the Level of Agreement Between Disease Activity Indices and Response Criteria Among Rheumatoid Arthritis Patients Treated with TNF Inhibitors

Background Several standardized response criteria and disease activity indices are used to assess treatment efficacy in rheumatoid arthritis (RA). These measures comprise different types and number of variables resulting in different weighting of individual variables within each of them. Objectives The aim of this analysis was to compare the performance of ACR, SDAI major and minor, and HAQ response criteria and to determine their level of agreement with the DAS28, SDAI, and CDAI definitions of low disease activity (LDA) and remission in RA patients treated with infliximab (IFX) or golimumab (GLM) in a real-world, Canadian, clinical practice setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with IFX or GLM. The analysis was based on RA patients treated with IFX between 2002-2014 or GLM between 2010-2014. Response was assessed with ACR20, ACR50, ACR70, HAQ improvement of 0.22 and 0.5, SDAI major (≥22) and minor improvement (≥10). Disease state was assessed with DAS28, SDAI, and CDAI definitions of LDA (<3.2, ≤11, ≤10, respectively) and remission (<2.6, ≤3.3, ≤2.8, respectively). The level of agreement was assessed with the proportion of concordant pairs over the total number of cases in each cross-tabulation and the Kappa statistic. Results A total of 830 RA patients with 4,100 available observations were included. The criteria for each definition of response/disease state were met for the following proportion of cases: ACR20 (66.4%), ACR50 (44.5%), ACR70 (26.4%), ΔHAQ≥0.22 (65.5%), ΔHAQ≥0.5 (53.4%), SDAI major improvement (55.8%), SDAI minor improvement (80.8%), DAS28 remission (29.4%), CDAI remission (20.4%), SDAI remission (21.8%), CDAI LDA (57.5%), SDAI LDA (58.1%), and DAS28-ESR LDA (46.0%). Statistically significant (Kappa P<0.001) associations were observed for all combinations of variables examined. Overall, the ACR response criteria performed better than the HAQ and SDAI response criteria in their agreement with LDA and remission. In general, higher levels of response in all three measures (ACR20 vs. ACR50 vs. ACR70; ΔHAQ≥0.22 vs. ΔHAQ≥0.5; SDAI minor vs. major) showed better agreement with LDA and remission. The highest level of agreement between response criteria and disease state was observed between the strictest definitions, namely between ACR70 and CDAI/SDAI remission; whereas, SDAI minor improvement showed the lowest level of agreement with remission, irrespective of definition. Conclusions This analysis showed that significant variation exists in the agreement between the various efficacy outcome measures. Thus, the choice of outcome measure used to make treatment decisions could have a significant impact on patient management. Disclosure of Interest E. Keystone Consultant for: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, P. Baer Consultant for: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, A. Avina-Zubieta: None declared, A. Jaroszynska: None declared, J. Rodrigues: None declared, R. Arendse Consultant for: Janssen, D. Sholter: None declared, M. Starr Consultant for: Janssen, A. Masetto: None declared, J. Sampalis Shareholder of: JSS Medical Research, Employee of: JSS Medical Research, E. Rampakakis Employee of: JSS Medical Research, C. Tkaczyk Employee of: Janssen, M. Shawi Employee of: Janssen, A. Lehman Employee of: Janssen, F. Nantel Employee of: Janssen, S. Otawa Employee of: Janssen

AB0220 What Proportion of Patients Fail To Achieve CDAI and SDAI Remission Based on Physician Global Assessment? An Analysis from A Prospective, Observational Registry

Background PtGA is included in the formula of all disease activity indices despite the fact that it may not accurately reflect RA disease activity, but rather reflect symptoms related to fibromyalgia, low back pain, depression or other conditions. We previously assessed the impact of the PtGA on the ability to achieve Boolean ACR/EULAR remission state. Objectives The aim of this analysis was to assess the proportion of patients failing to achieve DAS, CDAI and SDAI remission based on a real-world, routine clinical care setting in Canada. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with IFX or GLM. In this analysis, RA patients treated with infliximab between 2002-2014 or with golimumab between 2010-2014 were included. Modified versions of DAS28 (mDAS28), CDAI (mCDAI), and SDAI (mSDAI) were calculated by omitting PtGA from the formulas. Correlation of the standard and modified versions of each index was assessed with the Pearsons correlation coefficient. In the absence of validated thresholds for remission and LDA for the modified versions, the standard definitions were considered as the gold standard and ROC curve analysis was used to identify new thresholds for the modified versions. Cross-tabulations with the Chi-square test were used to assess the agreement between the standard and modified definitions of remission and LDA. Results One thousand nineteen RA patients with a mean (SD) age of 56.1 (13.5) years and disease duration of 8.5 (9.1) were included in the analysis. A strong correlation was observed between the standard and modified versions of DAS28 (r=0.98; P<0.001), CDAI (r=0.99; P<0.001), and SDAI (r=0.99; P<0.001). Based on ROC analysis the new thresholds for remission and LDA were: DAS28 (remission=2.6, LDA=3.1), CDAI (remission=2.5, LDA=10.5), SDAI (remission=3.3, LDA=10.9). Cross-tabulation of the standard and modified thresholds showed that an additional 10.1%, 10.6%, and 17.8% of non-remission cases for DAS28, CDAI and SDAI, respectively, would be classified as remission with the modified definitions. Similarly, an additional 11.5%, 21.2%, and 20.6% of non-LDA cases for DAS28, CDAI and SDAI, respectively, would be classified as LDA. Conclusions The results of this analysis have shown that PtGA could account for up to 10% of non-remission cases and up to 20% of non-LDA cases as measured by DAS, CDAI and SDAI. Further analyses are required to identify the determinants of patient global assessment. Disclosure of Interest P. Baer Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, E. Keystone Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, W. Bensen: None declared, C. Thorne Consultant for: Janssen, B. Haraoui Grant/research support from: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, UCB, Consultant for: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, UCB, D. Choquette Consultant for: AbbVie, Amgen, Celgene, BMS Canada, Janssen, Pfizer, R. Arendse Consultant for: Janssen, J. Kelsall Consultant for: Janssen, M. Sheriff Consultant for: Janssen, J. Sampalis Shareholder of: JSS Medical Research, Employee of: JSS Medical Research, E. Rampakakis Employee of: JSS Medical Research, C. Tkaczyk Employee of: Janssen, M. Shawi: None declared, A. Lehman Employee of: Janssen, F. Nantel Employee of: Janssen, S. Otawa: None declared