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Background An association between shorter disease duration and improved clinical efficacy has been shown in post hoc analyses of clinical trial data with biological therapies in Crohn’s disease (CD). The efficacy and safety of risankizumab (RZB) as induction and maintenance therapy have been recently reported. Here, the efficacy of RZB stratified by baseline CD duration is reported. Methods In ADVANCE (NCT03105128) and MOTIVATE (NCT03104413), patients with moderately to severely active CD received intravenous (IV) RZB induction therapy or placebo (PBO) for 12 weeks. Patients with clinical response to RZB IV induction were re-randomised in a 52-week maintenance study (FORTIFY, NCT03105102) to receive subcutaneous (SC) RZB or PBO (ie, withdrawal). For this post-hoc analysis, patient subgroups were stratified by years of CD duration at baseline (< 2, 2–5, > 5–10, and > 10 years). Induction analyses focused on patients who received RZB 600 mg IV or PBO for 12 weeks. As all patients who entered maintenance responded to RZB IV induction, maintenance analyses were limited to those patients who responded to induction and then received RZB 360 mg SC for 52 weeks. Clinical and endoscopic outcomes were evaluated using nonresponder imputation incorporating multiple imputation to handle missing data due to impact of the COVID-19 pandemic. Safety was assessed throughout the studies. Results The induction and maintenance analyses included 527 patients who received RZB 600 mg IV and 141 patients who received RZB 360 mg SC, respectively. At the end of induction (week 12), patients with CD duration of < 2 years achieved higher rates of endoscopic outcomes with IV RZB induction vs patients with longer durations of disease (Figure 1), and regardless of baseline CD duration, greater proportions of RZB-treated patients achieved clinical remission (defined by stool frequency and abdominal pain), endoscopic response, endoscopic remission, and ulcer-free endoscopy vs PBO (P ≤ .05). Clinical remission rates at week 12 were numerically higher in patients with CD duration of < 5 years vs > 5 years (Figure 1). Similar results for improved clinical and endoscopic outcomes associated with shorter disease duration were observed at week 52 with RZB 360 mg SC maintenance treatment (Figure 2). RZB was well tolerated with lower rates of serious adverse events and serious infections vs PBO in induction, across CD duration subgroups. Conclusion RZB induction and maintenance therapy was effective and well tolerated with a safety profile generally similar across CD duration subgroups. Achievement of clinical and endoscopic endpoints were higher in patients with shorter duration of CD, suggesting that earlier introduction of RZB therapy may lead to improved outcomes.

Background Control of endoscopic inflammation like endoscopic remission is an important treatment target in Crohn’s disease (CD), as suggested in the STRIDE II guidelines. This study evaluated the relationship of early improvement in endoscopic outcomes on hospitalisation and surgery rates at, 52 wks in patients with CD treated with risankizumab (RZB). Methods This post-hoc analysis uses data from three double-blind, randomised Phase, 3 induction (ADVANCE and MOTIVATE) and maintenance (FORTIFY) trials evaluating the efficacy and safety of RZB in patients with moderate to severe CD. Patients who responded to, 12-wk induction therapy with RZB IV (600 mg or, 1200mg) in ADVANCE or MOTIVATE and received up to, 52 wks of maintenance therapy with RZB SC (180 mg or, 360 mg) in FORTIFY were analysed. Incidence rates (events/100 person-years) of CD-related hospitalisation, CD-related surgery (surgical procedures due to adverse events or complications related to CD), all-cause hospitalisation, and all-cause surgery were evaluated from the beginning of maintenance to wk, 52 and compared between patients who achieved endoscopic outcomes at end of induction (wk, 12) and those who did not. Endoscopic response, endoscopic remission and ulcer-free endoscopy (absence of ulceration) were defined using the Simple Endoscopic Score for CD (SES-CD) (Figure, 1–3), as scored by a blinded central reviewer. Results A total of, 298 patients were included in the analyses. Patients who achieved endoscopic response (n=121) at wk, 12 had a significantly reduced incidence rate of CD-related hospitalisation, CD-related surgery, and all-cause hospitalisation by wk, 52 compared to those who did not achieve an endoscopic response (n=177) at wk, 12 (Figure, 1). Additionally, patients who achieved endoscopic remission at wk, 12 (n=83) had a significantly reduced incidence rate of CD-related hospitalisation, CD-related surgery, and all-cause hospitalisation by wk, 52, compared to those not achieving endoscopic remission at wk, 12 (n=215) (Figure, 2). Though not statistically significant, numerically lower rates of all-cause surgery were observed for patients who achieved endoscopic remission or endoscopic response at wk, 12. Significantly lower rates of CD-related hospitalisation, CD-related surgery, all-cause hospitalisation, and all-cause surgery by wk, 52 were observed among patients who achieved ulcer-free endoscopy (absence of ulceration) (n=70) vs those who did not (n=228) at wk, 12 (Figure 3). Conclusion Early improvement of endoscopic outcomes at wk, 12 is associated with significant reductions in hospitalisations and surgeries through, 52 wks for patients receiving RZB therapy.

Background Risankizumab (RZB), a selective interleukin-23 inhibitor, demonstrated clinically meaningful improvements in endoscopic outcomes in patients with moderate to severe Crohn’s disease (CD) during two phase 3 induction trials (ADVANCE and MOTIVATE) and the maintenance study (FORTIFY). Here, we compared the efficacy of RZB in inducing and maintaining improvements in endoscopic outcomes in patients with CD who demonstrated intolerance and/or inadequate response (IR) to biologic therapies (with prior bio-failure) versus those who demonstrated IR to conventional therapies only (without prior bio-failure). Methods Data included in this subgroup analysis included pooled data from patients randomized to receive intravenous (IV) RZB 600mg (N=527) or placebo (PBO) IV (N=362) every 4 weeks (wks) for 12wks during induction (ADVANCE+MOTIVATE), and data from patients receiving subcutaneous (SC) RZB 360mg (N=141) or withdrawn from RZB IV to receive PBO SC (withdrawal [PBO SC], N=164) every 8wks for 52-wks during maintenance. At Wks 12 and 52, endoscopic response, endoscopic remission, ulcer-free endoscopy (absence of ulceration), and deep remission (Wk52 only) were evaluated both in the overall population and in subpopulations of patients with and without prior bio-failure. (Endpoints are defined in Table footnotes). Safety was assessed throughout the studies. Results Approximately three-quarters of randomized patients included in this subgroup analysis had prior bio-failure (ADVANCE+MOTIVATE: 75.4%; FORTIFY: 73.8%). Higher rates of endoscopic response, endoscopic remission, and ulcer-free endoscopy were observed at Wk12 among patients receiving induction with RZB IV versus PBO IV. Subgroup analysis demonstrated treatment effects with risankizumab in patient subpopulations with and without prior bio-failure, with greater adjusted differences versus PBO in patients without prior bio-failure (Figure). At Wk52, endoscopic response, endoscopic remission, ulcer-free endoscopy, and deep remission rates favored RZB SC compared to withdrawal (PBO SC). Again, treatment effects were observed in patients with and without prior bio-failure, with greater adjusted differences versus withdrawal (PBO SC) in patients without prior bio-failure. RZB maintenance treatment was well-tolerated and no new safety signals were observed. The safety profile of RZB has been reported previously.1,2 Conclusion Induction and maintenance therapy with risankizumab achieved higher rates for endoscopic endpoints in patients with moderate to severe Crohn’s disease versus placebo, regardless of prior bio-failure status. However, numerically higher efficacy rates were observed in patients without prior bio-failure. 1 D’Haens, G. et al. in DDW 2021 2 Ferrante, M. et al. in UEGW 2021

Background In Crohn’s disease (CD), disease location affects treatment outcomes.1 This post hoc analysis assessed the efficacy of risankizumab (RZB), an interleukin 23 p19 inhibitor, by disease location. Methods In ADVANCE (NCT03105128) and MOTIVATE (NCT03104413), patients with moderately to severely active CD and intolerance or inadequate response to conventional and/or biologic therapy (ADVANCE) or to biologic therapy (MOTIVATE) received intravenous (IV) RZB induction therapy or placebo (PBO) for 12 weeks. Patients achieving clinical response to IV RZB induction were re-randomised in a maintenance study (FORTIFY, NCT03105102) to receive subcutaneous (SC) RZB or SC PBO (ie, withdrawal) for 52 weeks. This post hoc analysis included patients who received RZB 600 mg IV in either ADVANCE or MOTIVATE and patients who received RZB 360 mg SC in FORTIFY. Clinical and endoscopic outcomes were evaluated in patient subgroups stratified by CD location at baseline (ileal only, colonic only, ileal-colonic) using non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19. Results At week 12, significantly greater proportions of patients receiving RZB 600 mg IV achieved the co-primary endpoints CD Activity Index (CDAI) clinical remission and endoscopic response vs PBO in the colonic only (n = 190) and ileal-colonic (n = 252) subgroups (P < .001; Figure 1A–1B). At week 12, statistically higher proportions of RZB-treated patients achieved the composite endpoint CDAI clinical remission and endoscopic response, as well as endoscopic remission in the colonic only and ileal-colonic subgroups vs PBO (P < .001; Figure 1C–1D). At week 52, significantly greater proportions of patients receiving RZB 360 mg SC achieved the co-primary endpoints CDAI clinical remission and endoscopic response, composite CDAI clinical remission and endoscopic response, and endoscopic remission vs withdrawal (PBO SC) in the colonic only (n = 59) and ileal-colonic (n = 67) subgroups (P ≤ .05; Figure 2A–2D). In patients with endoscopic remission after 12 weeks of IV RZB (week 0 of maintenance), significantly more RZB-treated patients achieved sustained endoscopic remission at week 52 vs withdrawal (PBO SC) in the colonic only and ileal-colonic subgroups (P ≤ .01; Figure 2E). At weeks 12 and 52, efficacy rates were numerically lower in ileal only CD relative to colonic only and ileal-colonic CD. Results for ileal only CD are limited by the small number of patients in the subgroup (induction, n = 85; maintenance, n = 15). Conclusion RZB induction and maintenance therapy was effective in patients with moderately to severely active CD with greater benefits observed in patients with any colonic involvement.

Introduction Patients with rheumatoid arthritis (RA) who are treated with adalimumab (ADA) are offered a proprietary patient support program (PSP, AbbVie Care®). The main objective of this study was to examine the effectiveness of ADA on RA treatment course over time in the context of PSP utilization. Methods PASSION was a 78-week post-marketing observational study of RA patients with an insufficient response to ≥1 DMARD newly initiating ADA in routine clinical care that was conducted in Europe, Israel, Mexico, Puerto Rico, and Australia. One prior biologic DMARD was allowed. The primary endpoint was percentage of patients achieving the minimal clinically important difference (MCID; improvement of ≥0.22 compared to baseline) in Health Assessment Questionnaire (HAQ) Disability Index (HAQ-DI) at week 78. Additionally, multiple clinical and patient-reported outcomes (PROs) were evaluated over time. Patients were categorized based on their participation in the PSP: ever (PSP users) vs. never (PSP non-users). Safety events were monitored throughout the study. Results Overall, 42.8% of PSP users achieved the MCID in HAQ-DI at week 78 (improvement of at least 0.22 compared to baseline). From 1025 enrolled, 48.7% of patients were PSP users while treated with ADA. The percentage of patients achieving MCID in the HAQ-DI was higher in PSP users vs. PSP non-users (48.1 vs. 37.8%) at week 78 (p

Background Efficacy and safety of the IL-23 inhibitor risankizumab (RZB) have been assessed in patients with moderate-to-severe Crohn’s disease (CD) following induction/maintenance treatment.1,2 Responders to RZB in a Phase 2 induction/maintenance study2,3 could enrol in an open-label extension (OLE), NCT02513459.4 Final safety and efficacy results from this RZB OLE study are reported here. Methods Patients achieving clinical response (CResp) (decrease from baseline [BL] in CD Activity Index [CDAI] ≥100) without remission (CRem) (CDAI Results Sixty-five patients with CD were enrolled in the OLE, with 4 patients re-induced. At BL of the preceding study, median (range) age was 34 (19–67) years and median (range) disease duration was 10 (2–38) years. Sixty patients (92%) were previously exposed to TNF antagonists. In the OLE, median (range) exposure to RZB was 1014.0 (114–1317) days. Twenty-one (32%) patients prematurely discontinued RZB, including 6 (9%) who had developed an AE. AEs were reported in 60 (92%) patients; 23 (35%) experienced serious AEs. The most common AEs were nasopharyngitis (31%), gastroenteritis (23%), and fatigue (20%). Serious infections were reported in 6 (9%) patients and opportunistic infections in 3 (5%) patients. No tuberculosis, malignancies, or deaths occurred. At Week 0 of the current study, 47 (72%) patients were in CRem and 27 (42%) patients had ER. Both CRem and ER were sustained up to Week 152 (Table). Conclusion In this final analysis of patients with CD receiving long-term open-label RZB treatment, the safety profile of RZB remained consistent with previous data² with no new safety signals. Clinical and endoscopic remissions were sustained. References

Introduction Adults with moderate-to-severe Crohn’s disease (CD) who responded to risankizumab (RZB) in the phase 2 induction and maintenance study (Feagan, 2017) could enroll in an open-label extension (OLE) study. Interim efficacy and safety of RZB maintenance treatment from the OLE, up to 2 years, are reported. Methods Patients (pts) achieving clinical response (decrease from baseline [BL] in CD Activity Index [CDAI] ≥100) without remission (CDAI Results A total of 65 pts were enrolled (including 4 who were re-induced). Mean (standard deviation) exposure to RZB was 657.2 (190.73) days. At the data cut-off, 14 (21.5%) pts have discontinued the study. Up to wk 48, clinical remission rates were sustained and the proportion of pts with endoscopic remission increased from BL (table 1). Adverse events (AEs) were reported for 58 (89.2%) pts; 18(27.7%) pts had serious AEs. AEs occurring in >10% of pts were nasopharyngitis (26.2%), fatigue (16.9%), arthralgia and worsening CD (15.4% each). Four serious infections in 5 pts were perianal abscess (n=1), Campylobacter (n=1), viral gastroenteritis (n=2), and peritonitis (n=2). No events of tuberculosis, malignancies or deaths occurred. Conclusions In this interim analysis, clinical remission and endoscopic remission were sustained in CD pts receiving long-term RZB treatment. The safety profile of RZB was consistent with previously published data (Feagan, 2017). References Feagan BG, et al. Lancet 2017,29;389(10080):1699–1709. Feagan BG, et al. Gastroenterology 2017;152(5):S1310.

Background Adalimumab (ADA) is efficacious and well tolerated in adult patients with ulcerative colitis (UC).1,2 SERENE-UC (NCT02065622) is a study evaluating higher ADA dosing regimens from which induction study results have previously been reported3; here, we report data from the maintenance study. Methods This Phase 3, double-blind, randomised, multicentre study evaluated higher vs. standard ADA dosing regimens for induction and maintenance therapy in adult patients with moderately to severely active UC. Following completion of the induction study at Week 8, all patients were re-randomised 2:2:1 to ADA 40 mg every week (40 EW), ADA 40 mg every other week (40 EOW), or exploratory ADA 40 mg with therapeutic drug monitoring (TDM) regimens, stratified by induction treatment regimen, clinical response status at Week 8, and clinical remission (CRem) status at Week 8 among Week 8 responders. Efficacy endpoints were evaluated in Week 8 responders (ITT-RP) unless indicated differently. The primary efficacy endpoint was proportion of patients achieving CRem (full Mayo Score ≤2 with no subscore >1) at Week 52. The endoscopic component of the Mayo Score was scored via central reading. Non-responder imputation was used for missing values. Comparisons between 40 EW and 40 EOW dosing regimens used the Cochran–Mantel–Haenszel test adjusted for stratification. Safety assessment included a collection of adverse events (AEs), vital signs, and laboratory data. Results Of 852 patients in the Global (ex-Japan) induction study, 757 were re-randomised at Week 8 and 371 were included in the ITT-RP. In the ITT-RP, induction baseline demographics and disease characteristics were generally balanced across the 3 treatment arms; range across arms for mean UC disease duration was 6.2–7.8 years, 6.8–11.7% had prior infliximab use, and 62.5–63.5% were receiving corticosteroids. The overall mean ADA exposure was 252.2 days. The table displays results for efficacy endpoints. The observed safety profile was similar between maintenance treatment arms, including AEs of special interest (generally Conclusion In the Global (ex-Japan) study of SERENE-UC, CRem at Week 52 was numerically higher among Week 8 responders in patients receiving ADA 40 EW compared with 40 EOW maintenance regimens (∆ = 10.5%), but not statistically significant. Higher maintenance treatment with 40 EW was generally safe and well tolerated with a similar safety profile to 40 EOW. No new long-term safety concerns were observed. References

Aim: To evaluate the comparative effectiveness of biologics in inhibiting radiographic progression among rheumatoid arthritis (RA) patients. Materials & methods: Bayesian network meta-analysis of published trials investigating the USA FDA approved biologics treatment in RA patients, using methotrexate (MTX) as the reference comparator. Results: Nine trials met the inclusion criteria for base case analysis. Compared with MTX, most biologics (except golimumab) + MTX had significantly lower rates of radiographic progression at 1 year. Mean difference in radiographic progression rates between MTX monotherapy and biologics + MTX was highest for adalimumab + MTX (-3.8) and lowest for tocilizumab + MTX (-0.7). Inhibition of radiographic progression was sustained. Conclusion: Biologics inhibit radiographic progression in patients with RA at 1 year; however, published evidence beyond 1 year is limited.

Background Low trough levels of the tumour necrosis factor inhibitor, adalimumab (ADL), and anti-ADL antibodies (AAA) were reported to be correlated with lack of response at later time points in patients (pts) with rheumatoid arthritis (RA).1 Objectives To assess the ability of ADL trough levels and clinical assessments at Week 12 to predict clinical remission (REM) after 24 weeks (wks) of treatment with ADL ±methotrexate (MTX) in established RA pts. Methods Data from MTX inadequate responders (MTX-IR) pts with established RA with available measurement of ADL trough levels and clinical assessments at Wks 12 and 24 from several clinical trials were pooled: for pts who received ADL+MTX combination therapy from DE009, DE019, M10–261 and M13–390; for pts who received ADL monotherapy from DE011, M10–261 and M13–390. Efficacy endpoints at Wk 24 were DAS28-CRP Results Based on the cutoffs selected by the predictive model, ADL concentrations at Wk 12 were only slightly predictive for Wk 24 clinical assessment in the ADL monotherapy group, but not in the ADL+MTX group (table 1). However, based on achievement of the specified CDAI, SDAI or DAS28-CRP score at Wk 12 (selected by the model), pts were correctly predicted to reach Wk 24 REM or LDA with an accuracy of 80%–90% and area under the receiver operating characteristic curve (AUC) of 75%–90% (table 2). As an example, pts on ADL monotherapy with DAS28 Conclusions The ADL concentrations at Week 12 selected by the prediction model were weak predictors of disease control at 6 months, especially for pts on ADL+MTX combination therapy. However, using the model-selected cutoffs of composite clinical endpoints at Wk 12, disease control after 6 months of ADL±MTX treatment could be correctly predicted in 70%–80% of pts. References [1] Jani, et al. Arthritis & Rheumatol2015. [2] Huang X, et al. Statistics in Medicine2017. Acknowledgements AbbVie Inc was the study sponsor, contributed to study design, data collection, analysis and interpretation, and to writing, reviewing, and approval of final version. Medical writing support was provided by Naina Barretto, PhD, of AbbVie, Inc. Disclosure of Interest J. Smolen Grant/research support from: AbbVie Inc, Consultant for: AbbVie Inc, N. Mostafa Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, X. Huang Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, P. Noertersheuser Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, B. Kluender Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, K. Chen Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, J. Kalabic Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, I. Sainsbury Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, R. Oerlemans Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, S. Florentinus Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, G. Burmester Grant/research support from: AbbVie Inc., Bristol-Myers Squibb, Merck, Roche, Pfizer, and UCB, Consultant for: AbbVie Inc., Bristol-Myers Squibb, Merck, Roche, Pfizer, and UCB, Speakers bureau: AbbVie Inc., Bristol-Myers Squibb, Merck, Roche, Pfizer, and UCB

Background It is recognised that early diagnosis and treatment are important in maximising long-term quality of life in patients (pts) with rheumatoid arthritis (RA). Prior biologic disease modifying antirheumatic drug (bDMARD) use has been shown to affect treatment response to further biologic therapy including adalimumab (ADA). Objectives To evaluate the impact of prior bDMARD use on clinical and pt-reported outcomes in pts enrolled in the PASSION study. Methods PASSION was a 78-wk postmarketing, multinational, observational study that assessed the effectiveness of ADA in pts with moderate to severe RA receiving ADA in routine clinical care in the context of participation in the voluntary AbbVie pt support program. Pts with an insufficient response to ≥1 DMARD (1 prior bDMARD was allowed) and newly initiating ADA were enrolled and categorised as bDMARD-naive or bDMARD-experienced. For the present analysis, ADA treatment response was determined by evaluating least squares (LS) mean change from baseline for multiple clinical and pt-reported outcomes (table 1). Missing data for each efficacy endpoint were imputed using last observation carried forward, and differences between groups for efficacy endpoints at wks 24, 52, and 78 were based on ANCOVA models adjusting for baseline and demographic variables (table 1). Additionally, the percentages of pts at each time point (observed population) who achieved HAQ-DI minimal clinically important difference (MCID; improvement from baseline of ≥0.22) were assessed. Results Of 1025 pts included in the intent-to-treat population, 182 were bDMARD-experienced and 843 were bDMARD-naive at baseline. There were no significant differences between groups in sex, race, ethnicity, weight, height, body mass index, TJC28, SJC28, and pain at baseline. However, bDMARD-experienced pts were significantly older, had longer RA duration, and had lower values for HAQ-DI, DAS28(CRP), CDAI, SDAI, PtGA, and PhGA than bDMARD-naive pts at baseline (p Conclusions Among pts with moderate to severe RA that initiated ADA treatment in the PASSION study, bDMARD-naive pts achieved significantly larger improvements from baseline to wk 78 in a variety of clinical and pt-reported outcomes compared with bDMARD-experienced pts. A large proportion of both bDMARD-naive and bDMARD-experienced pts achieved HAQ–DI MCID with ADA treatment. Acknowledgements AbbVie funded the study and analysis, and approved the abstract for submission. Medical writing support was provided by Wendy van der Spuy, PhD, of Complete Healthcare Communications, LLC (West Chester, PA, USA), and was funded by AbbVie. Disclosure of Interest F. Van den Bosch Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB, S. Wassenberg Grant/research support from: AbbVie, BMS, Fuji, Gilead, Novartis, Pfizer, Roche, Sandoz, and UCB, Consultant for: AbbVie, Celgene, Janssen, Chugai, Lilly, Novartis, Pfizer, MSD, and UCB, Speakers bureau: AbbVie, Celgene, Janssen, Chugai, Lilly, Novartis, Pfizer, MSD, and UCB, P. Zueger Employee of: AbbVie, J. Kalabic Employee of: AbbVie, M. Wu Employee of: AbbVie, K. Monastiriakos Employee of: AbbVie, A. Ostor Grant/research support from: Lilly, Roche, MSD, AbbVie, Pfizer, Novartis, Janssen, and Bristol-Myers Squibb, Consultant for: Lilly, Roche, MSD, AbbVie, Pfizer, Novartis, Janssen, and Bristol-Myers Squibb

Background JIA is the most common chronic inflammatory rheumatic disease of childhood. TNF inhibitors are used for long-term control of pJIA disease. Objectives To evaluate the 7 year (y) safety of Adalimumab treatment with or without methotrexate (ADA±MTX) when used in current clinical practice for treatment of patients (pts) with active pJIA. Methods This is a 7 y interim analysis of an ongoing, multicenter, non-interventional, observational registry of pts with pJIA with up to10 y safety follow-up. Included pts were treated with ADA±MTX or MTX alone as comparison arm according to routine clinical care in PRINTO/PRCSG centres in EU, USA and Australia. MedDRA observational adverse events (AEs) were recorded from 1st day in the registry through last contact, irrespective of duration of registry treatment. Results In January 2014, enrollment was complete. As of June 1, 2016 cut-off date, 838 pts (301- MTX arm and 537 - ADA±MTX arm) were treated in the registry. There were 39 pts who rolled over from MTX to ADA±MTX arm. At registry entry mean pJIA disease duration was 1.3 y and 3.7 y and mean AJC71 was 5.8 and 5.2 for MTX and ADA±MTX arms, respectively. CHAQ disability index was 0.6 for both arms. Mean duration of study drug exposure in registry was 2.0 y (range: 0.0 – 7.1) and 2.5 y (range: 0.0 – 7.9) for MTX and ADA±MTX arms, respectively. Mean duration of observation in registry was 3.9 y (range: 0.0 – 7.2) and 3.5 y (range: 0.0 – 7.9) for MTX and ADA±MTX arms, respectively. Overall, 213 pts (70.8%) in MTX and 225 pts (41.9%) in ADA±MTX arms discontinued registry drug through 7 y. Main reasons (not exclusively) for registry drug discontinuation for MTX arm: pts required additional therapy (32.6%), other (13.3%), lack of efficacy (11.6%), AEs (9.3%), or pts achieved JIA remission (8.6%); for ADA±MTX arm: lack of efficacy (17.9%), other (7.3%), lost to follow-up (5.6%), AEs (5.4%), or pts achieved JIA remission (5.0%). Frequencies and rates of treatment-emergent AEs (from 1st dose date of registry drug in registry up to last dose + 70 days in registry, excluding AEs occurring during treatment interruption) were similar to those reported for observational AEs (from 1st day in registry up to last contact irrespective of drug treatment duration) (Table). Rate of serious infections was similar between MTX and ADA±MTX arms. One pt (0.2%) reported an event of opportunistic infection (fungal oesophagitis) in ADA±MTX arm. No reports of deaths, malignancies, active tuberculosis, oral candidiasis, demyelination, or congestive heart failure. Conclusions Overall, ADA±MTX was well-tolerated in these pts with pJIA with no new safety signals. The retention rate for registry drug was higher in ADA±MTX arm compared to MTX arm. Acknowledgements AbbVie sponsored the study & contributed with PRINTO & PRCSG to analysis, review, approval of the abstract. X. Leahy & A. Deshmukh (AbbVie) contributed to research. Medical writing: G. Patki (AbbVie). Disclosure of Interest N. Ruperto Grant/research support from: AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., “Francesco Angelini”, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Pharmaceuticals, Employee of: GASLINI Hospital, Speakers bureau: Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, Janssen Biologics B.V., MedImmune, Roche, and Wyeth/Pfizer, H. Brunner Consultant for: AbbVie Inc., AstraZeneca, Centocor, Bristol-Myers Squibb, Boehringer-Ingelheim, Pfizer, Regeneron, Hoffman La-Roche, Novartis, Takeda, UCB, and Genentech, Speakers bureau: Genentech Pharmaceuticals, K. Nanda Consultant for: Medac Pharma, Inc., M. Toth: None declared, I. Foeldvari Consultant for: AbbVie and Novartis, J. Bohnsack Consultant for: Novartis, D. Milojevic Consultant for: Genentech and Novartis, C. Rabinovich Grant/research support from: UCB Pharma, Janssen, D. Kingsbury: None declared, K. Marzan Grant/research support from: AbbVie, P. Quartier Grant/research support from: AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, and Swedish Orphan Biovitrum, Consultant for: AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, Swedish Orphan Biovitrum, and Sanofi, K. Minden Grant/research support from: Pfizer, AbbVie and Roche/Chugai, Consultant for: Pfizer, Roche, and Pharma-Allergan, Speakers bureau: Pfizer, Roche, and Pharma-Allergan, E. Chalom Speakers bureau: AbbVie, G. Horneff Grant/research support from: AbbVie, Pfizer, Novartis, and Roche, Speakers bureau: AbbVie, Novartis, Sobi, Pfizer, and Roche, R. Kuester Grant/research support from: AbbVie Inc. and Wyeth/Pfizer, J. Dare Grant/research support from: AbbVie, AstraZeneca, Bristol-Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB, M. Bereswill Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie, H. Kupper Shareholder of: AbbVie, Employee of: AbbVie, A. Martini Grant/research support from: AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., “Francesco Angelini”, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Pharmaceuticals, Employee of: GASLINI Hospital, Speakers bureau: Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, and MedImmune, D. Lovell Consultant for: AstraZeneca, Centocor, Bristol-Myers Squibb, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UBC, Xoma, Genentech, Amgen and Forest Research, Speakers bureau: Wyeth Pharmaceuticals

Background Patients (pt) with Rheumatoid arthritis (RA) who are treated with adalimumab (ADA) are offered a Patient Support Program (PSP) with variety of services. To date, no prospective study has been conducted to analyze the acceptance and the impact of these PSPs on treatment effectiveness and pt satisfaction. Objectives The purpose of this study was to examine the effectiveness of ADA on rheumatoid arthritis (RA) treatment course in the context of PSP participation. Methods PASSION (NCT01383421) was a 78-week (wk) post-marketing observational study of pts with RA receiving ADA in routine clinical care. Pts from the EU, Israel, Mexico, Puerto Rico, and Australia with an insufficient response to ≥1 disease-modifying antirheumatic drug (DMARD) newly initiating ADA (1 prior biologic DMARD was allowed) were enrolled. The primary endpoint was the % of pts achieving the minimal clinically important difference (MCID; improvement of ≥0.22 compared to baseline [BL]) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at wk 78. Non-responder imputation (NRI) was used to account for the missing values. Secondary clinical parameters included % of pts achieving MCID in HAQ-DI at wks 24 and 52 and changes in the 28-joint DAS based on CRP (DAS28(CRP)), Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) at wks 24, 52, and 78 vs BL. Pts were categorized based on their participation in the PSP: ever (PSP users) vs never (PSP non-users) and outcomes were compared after adjusting for corresponding BL values. Results Overall, the primary endpoint, percentage of pts achieving the MCID for HAQ-DI, was achieved by 72.1% (as observed) and 42.8% (NRI) of pts at week 78 with the percentage of pts achieving the MCID for HAQ-DI significantly higher in PSP users vs PSP non-users (48.1% vs 37.8% [NRI]; P Conclusions The final study results showed that, in pts with moderate to severe RA who initiated ADA, significantly better improvement in functional and clinical outcomes was achieved in the PSP users vs the PSP non-users. Improvements were achieved at early timepoints and continued to increase throughout the study. Acknowledgements AbbVie funded the study and the analysis, and approved the abstract for submission. Medical writing assistance was provided by Gaurav Patki, PhD and Benjamin Wolfe, PhD from AbbVie. Disclosure of Interest F. Van den Bosch Consultant for: AbbVie, Celgene, Janssen, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene, Janssen, Pfizer, and UCB, A. Ostor Consultant for: Roche, Chugai, MSD, AbbVie, Pfizer, Novartis, Napp, and BMS, S. Wassenberg Consultant for: AbbVie, Celgene, Novartis, Pfizer, MSD, Lilly, Janssen and UCB, Speakers bureau: AbbVie, Celgene, Novartis, Pfizer, MSD, Lilly, Janssen and UCB, J. K. Anderson Shareholder of: AbbVie, Employee of: AbbVie, N. Chen Shareholder of: AbbVie, Employee of: AbbVie, C. Wang Shareholder of: AbbVie, Employee of: AbbVie, V. Garg Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie

Background JIA is the most common chronic inflammatory rheumatic diseases of childhood. Due to their long-term safety and efficacy, biologic disease modifying antirheumatic drugs (DMARD) are commonly necessary for control of pJIA patients (pts). Objectives To evaluate 6-year (y) safety and 2 y effectiveness profile of Adalimumab with or without methotrexate (ADA±MTX) when used in current clinical practice for the treatment of moderately to severely active pJIA. Methods This is a 6 y interim analysis of an ongoing, multicenter, non-interventional, observational registry of pts with moderately to severely active pJIA with up to10 y safety follow-up. Included pts are treated with either ADA±MTX or MTX alone as part of their routine clinical care enrolled in the US, EU, and Australia. MedDRA observational adverse events (AEs) were recorded from the first day in the registry through last contact, irrespective of the duration of registry treatment. Effectiveness was assessed by 27-joint juvenile arthritis disease activity score (JADAS27), based on CRP. Results As of January 2014, enrollment was complete. As of June 1, 2015 cut-off date, 846 pts (543 in ADA±MTX and 303 in MTX groups) were treated in the registry. There were 39 pts who rolled over from the MTX to the ADA±MTX arm. At registry entry mean pJIA disease duration was 1.4 y and 3.7 y for MTX and ADA±MTX arms, respectively. At baseline (BL), mean AJC71 was 5.8 and 5.3 for MTX and ADA±MTX arms, respectively, and Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI) was 0.6 for both arms. At data cutoff, the mean duration of study exposure was 1.81 y and 2.15 y for MTX and ADA±MTX arms, respectively. Overall, 206 pts (68%) in the MTX and 216 pts (39.8%) in the ADA±MTX arms discontinued registry drug through 6 y. The main reasons for registry drug discontinuation for the MTX arm: pts required additional therapy (32.3%), other (11.9%), lack of efficacy (10.9%), AEs (8.3%), or pts achieved JIA remission (7.6%), and for ADA±MTX arm: lack of efficacy (16%), lost to follow-up (7.2%), other (5.9%), and AEs (5.3%). Frequencies and rates of treatment-emergent AEs were similar to those reported for observational AEs (Table). There were no reports of deaths, malignancies, opportunistic infections, active TB, oral candidiasis, or CHF. Mean JADAS27 (CRP) improved from 12.2 at BL to 9.7, 5.2, 4.4, 3.5, 2.2 at months 1, 6, and 12, 18, 24 for pts in the MTX and from 11.8 at BL to 7.0, 4.-2, 4.2, 3.6, 3.9 in the ADA±MTX arms, respectively (observed data). Conclusions Overall, ADA±MTX was well-tolerated in these pts with pJIA with no new safety signals. Discontinuations from the registry drug were relatively high through 6 y, but greater in the MTX only arm. Acknowledgement AbbVie sponsored the study & contributed with PRINTO & PRCSG to the analysis, review, and approval of the abstract. Xiaolei Leahy & Ashish Deshmukh of AbbVie contributed to the research. Medical writing support was provided by Gaurav Patki, PhD, of AbbVie. Disclosure of Interest N. Ruperto Grant/research support from: AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., “Francesco Angelini”, GlaxoSmithKline, Italfgroupaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Phgroupaceuticals., Employee of: GASLINI Hospital, Speakers bureau: Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, Janssen Biologics B.V., MedImmune, Roche, and Wyeth/Pfizer, D. J. Lovell Consultant for: AbbVie Inc., AstraZeneca, Centocor, Bristol-Myers Squibb, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UBC, Xoma, and Genentech, Speakers bureau: Wyeth Pharmaceuticals, and served on data and safety monitoring boards for Amgen and Forest Research, C. Wallace Grant/research support from: Pfizer and Amgen, Consultant for: Amgen and Novartis., M. Toth: None declared, I. Foeldvari Consultant for: AbbVie and Novartis, J. Bohnsack Consultant for: Novartis, D. Milojevic Consultant for: Genentech and Novartis, E. Rabinovich Grant/research support from: UCB Pharma, Janssen Research & Development, LLC, Hoffmann-La Roche Inc., and AbbVie, D. Kingsbury Grant/research support from: AbbVie, K. Marzan Grant/research support from: AbbVie., P. Quartier Grant/research support from: AbbVie, Novartis, Consultant for: AbbVie, Novartis, K. Minden Grant/research support from: Pfizer and Abbvie, Consultant for: Pfizer, Abbvie, Roche/Chugai, Novartis, Medac and Pharma-Allergan., E. Chalom Speakers bureau: AbbVie, G. Horneff Grant/research support from: AbbVie, Pfizer, and Roche, Speakers bureau: AbbVie, Novartis, Pfizer, and Roche, R. M. Kuester Grant/research support from: AbbVie Inc. and Wyeth/Pfizer, J. Dare Grant/research support from: AbbVie, AstraZeneca, Bristol-Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB, M. Heinrich Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, H. Kupper Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, J. Kalabic Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, A. Martini Grant/research support from: AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., “Francesco Angelini”, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Pharmaceuticals, Employee of: GASLINI Hospital, Speakers bureau: Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, and MedImmune., H. I. Brunner Consultant for: AbbVie Inc., AstraZeneca, Centocor, Bristol-Myers Squibb, Boehringer-Ingelheim, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UCB, and Genentech, Speakers bureau: Genentech Pharmaceuticals.

Background Obese rheumatoid arthritis (RA) patients (pts) may have higher levels of inflammatory mediators, greater joint swelling and tenderness, and suboptimal response to therapy. Objectives We assessed disease activity and treatment response in obese RA pts, using ultrasonography (US) and clinical measures. Methods This post hoc analysis used observed data from the MUSICA trial1 which evaluated the efficacy of high [20 mg/week (wk)] or low (7.5 mg/wk) doses of methotrexate (MTX) in combination with adalimumab (ADA) for 24 weeks (wks) in RA pts with previous inadequate response to MTX who initiated ADA. Pts were grouped according to body mass index (BMI) at baseline (BL): normal BMI Results Out of 308 pts at BL, 69 pts (22.4%) had BMI Conclusions Among obese RA pts initiating ADA, those on low dosage of concomitant MTX had poorer responses than pts in the normal and overweight categories, as measured clinically and by ultrasound imaging, although this effect was partly overcome by wk 24. Obese RA pts may have an improved clinical benefit if ADA is initiated with high (20 mg/week), rather than low dosage of concomitant MTX. References Kaeley et al. ACR/ARHP 2013 Annual Meeting. Boston, MA, USA Acknowledgement AbbVie: study sponsor, contributed to study design, data collection, analysis, interpretation and writing, reviewing and approval of abstract. Medical writing support: Naina Barretto of AbbVie Disclosure of Interest G. Kaeley Consultant for: AbbVie, V. Ranganath Grant/research support from: Genentech, Pfizer, D. MacCarter Consultant for: AbbVie, Speakers bureau: AbbVie, A. Pangan Shareholder of: AbbVie, Employee of: AbbVie, X. Wang Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie

Background In rheumatoid arthritis (RA) patients (pts) receiving corticosteroids (CS) or methotrexate (MTX) with an anti-TNF, such as adalimumab (ADA), the concomitant CS or MTX dose may be reduced if pts respond well or have side-effects. Objectives To assess treatment effectiveness in pts whose MTX or CS oral dose was reduced over 10 years (y) of open label (OL) ADA treatment. Methods This was observed data from OL extensions (OLE) of the PREMIER and DE019 trials. 1,2 In PREMIER, MTX-naive, early RA pts received ADA/MTX/ADA+MTX for 2y, and optional OL ADA for upto 8y. In DE019, biologic-naive, established RA pts received 20 mg ADA+MTX/ 40 mg ADA+MTX/PBO+MTX for 1y and optional OL ADA+MTX for upto 9y. In both OLEs, MTX could be added/adjusted at the investigator9s discretion, and oral CS dose could be tapered in pts who responded. Effectiveness at final visit (FV) was assessed by the numbers of pts achieving TJC68 =0, SJC66 =0, improvement from baseline in HAQ-DI ≥0.5 (HAQ-DI 0.5), ACR20/50/70 criteria and 28-joint disease activity score based on C-reactive protein (DAS28-CRP) Results In PREMIER , by the pt9s FV, out of 375 pts who had any oral CS, 220 (58.7%) were on ongoing CS; 155 (41.3%) had stopped. Among the 375 pts, 32% had a stable CS dose and 26.1% had a CS dose reduction. Dose reduction did not affect the proportion of pts reaching ACR criteria, HAQ-DI 0.5, and DAS28-CRP DE019 , by the pt9s FV, out of 352 pts who received any oral CS, 207 (58.8%) were on ongoing CS and 145 (41.2%) had stopped CS. Among the 352 pts, 141 (40%) had a stable CS dose and 82 pts (23.3%) had a dose reduction. Out of 550 pts on MTX during the study, 497 (90.4%) were receiving MTX, and 53 (9.6%) had stopped by FV; 345/550 pts (62.7%) had stable MTX and 158 (28.7%) had a reduction. Reduction of CS or MTX did not affect the proportion of pts who reached the ACR criteria, HAQ-DI 0.5 and DAS28-CRP Conclusions Overall, effectiveness associated with continuous ADA treatment was not sacrificed in pts in whom concomitant oral CS or/and MTX doses were reduced or discontinued, although many of these pts were likely responding well at the time of taper. References Keystone et al. J Rheum 2013;40:1487–97; Keystone et al. J Rheum, 2014;41:5–14 Acknowledgement AbbVie: study sponsor, contributed to design, data collection, analysis, interpretation; in writing, reviewing and approval of final version. Medical writing support: Naina Barretto of AbbVie. Disclosure of Interest E. Keystone Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Janssen, Pfizer, Roche, and UCB, Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Janssen, Pfizer, Roche, and UCB, Speakers bureau: AbbVie, Amgen, AstraZeneca, BMS, Janssen, Pfizer, Roche, and UCB, F. Breedveld Consultant for: Centocor, Schering-Plough, Amgen/Wyeth, and AbbVie, A. Kavanaugh Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB, Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB, Y. Zhang Shareholder of: AbbVie, Employee of: AbbVie, I. Sainsbury Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie

Background Adalimumab (ADA) is a tumor necrosis factor (TNF) inhibitor used for treatment of chronic immune diseases. The safety of ADA treatment in pediatric patients (pts) is particularly important since prolonged treatment for these conditions is often required. Objectives To evaluate the safety of ADA, alone or in combination with concomitant therapy, in pediatric pts with polyarticular juvenile idiopathic arthritis (pJIA), enthesitis-related arthritis (ERA), psoriasis (Ps), and Crohn9s disease (CD) Methods Safety data from 6 clinical trials and their open-label extension studies were analyzed. Pts treated for pJIA (NCT00048542, NCT00775437, and NCT00690573) and ERA (NCT01166282 [interim week-52 data]) received ADA 24 mg/m 2 body surface area every other week (eow) or 20 mg eow ( Results The analysis included 577 pediatric pts, representing 1423.3 PY of ADA exposure (Table). Over 90% of pts across indications reported treatment-emergent AEs. Common AEs were headache (13.8, 46.9, and 23.8 E/100 PY for pJIA and ERA, Ps, and CD, respectively), nasopharyngitis (12.4, 57.6, and 14.1 E/100 PY, respectively), and upper respiratory tract infection (30.1, 24.7, and 14.9 E/100 PY, respectively). The rates of serious AEs (E/100 PY) were 13.4 for pts with pJIA and ERA, 7.4 for pts with Ps, and 32.3 for pts with CD. One death was reported from an accidental fall (pt with Ps). There were no reports of malignancies, demyelinating disorders, cardiovascular events, pulmonary embolism, reactivation of hepatitis B, Stevens-Johnson syndrome, or erythema multiforme. Conclusions The safety profile of ADA in pediatric pts with pJIA, ERA, Ps, or CD was similar across indications, and no new safety signals specific to the pediatric population were identified. Acknowledgement AbbVie funded the studies (NCT00048542, NCT00775437, NCT00690573, NCT01166282, NCT01251614, NCT00409682, and NCT00686374); contributed to their design; and was involved in the collection, analysis, and interpretation of the data, and in the writing, review and approval of the abstract. All authors contributed to and maintained control over the final content; Natalia Zhukovskaya, PhD, of Complete Publication Solutions, LLC, provided medical writing support. Disclosure of Interest G. Horneff Grant/research support from: AbbVie, Chugai, Pfizer, and Roche, M. Seyger Grant/research support from: AbbVie, Almirall, Astellas, Leo Pharma, and Pfizer, Consultant for: AbbVie, Almirall, Boehringer Ingelheim, and Pfizer, Speakers bureau: Pfizer; and travelled with AbbVie, Pfizer, and Leo Pharma to meetings (fees were paid directly to the institution for these activities)., D. Arikan Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie, J. Anderson Shareholder of: AbbVie, Employee of: AbbVie, A. Lazar Shareholder of: AbbVie, Employee of: AbbVie, D. Williams Shareholder of: AbbVie, Employee of: AbbVie, C. Wang Shareholder of: AbbVie, Employee of: AbbVie, R. Tarzynski-Potempa Shareholder of: AbbVie, Employee of: AbbVie, J. Hyams Consultant for: Celgene, Takeda, AstraZeneca, Lilly, Genentech, and UCB. Served as an advisory board member for AbbVie and Janssen

Background The long-term safety of anti-tumor necrosis factor (TNF) drugs is particularly important in pediatric patients (pts) who may require prolonged treatment of their inflammatory disease. Objectives To evaluate long-term rates of serious adverse events (AE) and anti-TNF AEs of special interest in adalimumab (ADA) clinical trials in pediatric pts with polyarticular or polyarticular course juvenile idiopathic arthritis (pJIA) or enthesitis-related arthritis (ERA). Methods Safety data from pts treated with ADA, either dosed 24 mg/m 2 BSA every other week (eow) or 20 mg eow ( Results ADA was administered to 274 pts, representing 769.0 PY of exposure. Infections, the most common AE, occurred in ≥10% of pts. Serious infection was the most frequently reported SAE (table). One case of latent TB was reported. No malignancies, opportunistic infections, or deaths were reported. 8.4% of pts (23/274) discontinued study due to AE (range, 5.1% in age Conclusions These data provide support for the long-term safety of ADA in pediatric pts aged 2–17 yrs with pJIA or ERA and demonstrate a safety profile consistent with ADA in adult pts and known information about the anti-TNF class. Acknowledgements AbbVie funded the studies (NCT00048542, NCT00690573, NCT00775437, and NCT01166282), contributed to their design and was involved in the collection, analysis, and interpretation of the data, and in the writing, review, and approval of the publication. Medical writing support was provided by Kathleen V. Kastenholz, PharmD, MS, of AbbVie. Disclosure of Interest N. Ruperto Grant/research support from: AbbVie, AstraZeneca, BMS, Janssen, “Francesco Angelini”, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences, Sobi, Xoma, and Wyeth for the PRINTO network paid to GASLINI Hospital, Consultant for: AbbVie, Amgen, Astellas, Alter, AstraZeneca, Biogen Idec, Boehringer, BMS, CD-Pharma, Celgene, Crescendo Bioscience, EMD Serono, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo-Nordisk, Pfizer, Roche, Sanofi Aventis, Servier, Sinergie, Takeda, and Vertex, Speakers bureau: AbbVie, Amgen, Astellas, Alter, AstraZeneca, Biogen Idec, Boehringer, BMS, CD-Pharma, Celgene, Crescendo Bioscience, EMD Serono, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo-Nordisk, Pfizer, Roche, Sanofi Aventis, Servier, Sinergie, Takeda, and Vertex, D. Lovell Consultant for: AbbVie, AstraZeneca, Boehringer Ingelheim, Celgene, Centocor, Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Horizon Pharma, Janssen Biologics B.V., Novartis, Pfizer, Regeneron, Hoffman La-Roche, and UBC and served on data and safety monitoring boards for Forest Research, Speakers bureau: Genentech and Wyeth Pharmaceuticals, D. Kingsbury Grant/research support from: AbbVie, R. Burgos-Vargas Grant/research support from: AbbVie, Consultant for: AbbVie, BMS, Janssen, Pfizer, and Roche, Speakers bureau: AbbVie, BMS, Janssen, Pfizer, and Roche, T. Imagawa Grant/research support from: AbbVie/Eisai and Novartis, Consultant for: AbbVie/Eisai, Speakers bureau: AbbVie/Eisai, Chugai, and Mitsubishi Pharma, G. Horneff Grant/research support from: AbbVie, Pfizer, and Roche, Speakers bureau: AbbVie, Novartis, Pfizer, and Roche, P. Quartier Grant/research support from: AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, and Swedish Orphan Biovitrum, Consultant for: AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, and Swedish Orphan Biovitrum, S. Goodman Consultant for: Amgen, A. Reiff Consultant for: AbbVie and Amgen, Speakers bureau: AbbVie and Amgen, E. Giannini Consultant for: AbbVie, A. Cardoso Shareholder of: AbbVie, Employee of: AbbVie, J. Anderson Shareholder of: AbbVie, Employee of: AbbVie, N. Varothai Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie, A. Martini Grant/research support from: AbbVie, AstraZeneca, BMS, Janssen, “Francesco Angelini”, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences, Xoma, and Wyeth for the PRINTO network paid to GASLINI Hospital, Consultant for: AbbVie, Amgen, Biogen Idec, Boehringer, BMS, Celgene, EMD Serono, Janssen, MedImmune, Medac, Novartis, Novo- Nordisk, Pfizer, Roche, Sanofi Aventis, Servier, Takeda, and Vertex, Speakers bureau: AbbVie, Amgen, Biogen Idec, Boehringer, BMS, Celgene, EMD Serono, Janssen, MedImmune, Medac, Novartis, Novo- Nordisk, Pfizer, Roche, Sanofi Aventis, Servier, Takeda, and Vertex

Background Methotrexate (MTX) is used as monotherapy or in combination with other DMARDs in the treatment of patients (pts) with rheumatoid arthritis (RA). Objectives To evaluate the effects of low and high MTX doses in combination with initiation of ADA on patient-reported outcomes (PROs) in MTX-inadequate responders (MTX-IR) with moderate-to-severe RA. Methods MUSICA (NCT01185288) was a randomized, double-blind, controlled trial evaluating the efficacy of two different dosages of MTX, 7.5 or 20 mg/week (wk) in combination with ADA (40 mg every other wk) for 24 wks in MTX-IR RA pts. Pts entering the study had been receiving ≥15 mg/wk MTX for at least 12 wks. At each study visit, from baseline (BL) to wk 24, the following PROs were recorded: quality of sleep, using the Medical Outcomes Sleep (MOS) Index II; Satisfaction with treatment medication, using the Treatment Satisfaction Questionnaire for Medication (TSQM); and sexual impairment due to RA, using a single question of how much did your RA affect sexual functioning over the past 7 days. Last observation carried forward (LOCF) was used to account for missing values. Results 154 pts were enrolled in the 7.5 mg/wk MTX+ADA arm, and 155 pts in the 20 mg/wk MTX+ADA arm. Both arms were similar for BL demographics (mean age 54.8, 25.2% male), disease characteristics (mean disease duration 5.3 years; mean DAS28(CRP) of 5.8). BL values for MOS, TSQM and sexual impairment were similar. At wk 24 after treatment, improvements were observed in all subdomains of the MOS Sleep Index and the TSQM, and Sexual Impairment due to RA (Table). Except for the MOS Sleep Index-Awakened Short of Breath/headache domain, TQSM-Side effects and TQSM-Convenience, the differences from BL were statistically significant. At wk 24, the difference between the scores for the two treatment groups was not statistically significant for any of the subdomains in the MOS Sleep Index or the subdomains in the TSQM, except for Convenience (p=0.023), which was lower for the 20 mg/wk MTX dosage group. At wk 24 after treatment, the difference between the scores between the two treatment groups was not statistically significant for Sexual Impairment. Conclusions Similar to observations in pts with early RA (1), the addition of ADA to MTX in pts with moderate-severe disease and insufficient MTX response, led to improvements in quality of sleep, and satisfaction with treatment medication after 24 wks. Improvements in sexual impairment were also observed. Improvements in all three PROs were observed regardless of the concomitant MTX dosage. References Burmester et al; ARD 2014; 0:1-8 Acknowledgements AbbVie sponsored the study (NCT01185288), contributed to its design, participated in the collection, analysis, and interpretation of the data, and in the writing, reviewing, and approval of the final version. Statistical support was provided by Peigang Li, PhD, and Shufang Liu, PhD; medical writing support was provided by Naina Barretto, PhD, all of AbbVie. Disclosure of Interest G. Kaeley Consultant for: AbbVie, M. Nishio Speakers bureau: AbbVie, D. MacCarter Consultant for: AbbVie, Speakers bureau: AbbVie, J. Griffith Employee of: AbbVie, V. Garg Employee of: AbbVie, H. Kupper Employee of: AbbVie, J. Kalabic Employee of: AbbVie

Background Patients (pts) may benefit from the use of a patient support program (PSP) to manage their rheumatoid arthritis (RA). Objectives To assess the impact of PSP utilization on adalimumab (ADA) effectiveness for RA treatment in clinical settings. Methods PASSION (NCT01383421) is a post-marketing observational study to explore and describe the effectiveness of ADA on the course of RA treatment and pt satisfaction over time in the context of utilization of the PSP. The study enrolled pts with moderate to severe RA with an insufficient response to ≥1 disease-modifying antirheumatic drug (DMARD) and initiated ADA at participating sites in the EU, Mexico, Puerto Rico, and Australia. Pts had to be ADA-naive and treated with ≤1 prior biologic DMARD. Pts were prescribed ADA according to the local product label and had an option to utilize the PSP while participating in the study. The PSP comprised “Core elements” (starter pack, call center/hotline, nursing services, educational material, and injection guide; offered in all participating countries) and “Other elements” (eg, refill reminders, email, newsletters, support groups, home delivery, and financial assistance; varied by country). The primary endpoint is the % of pts achieving the minimal clinically important difference (MCID; improvement of ≥0.22) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at week (wk) 78 vs baseline (BL). Secondary clinical parameters include % of pts achieving MCID in HAQ-DI at wks 12, 24, 36, 52, and 64 vs BL and changes in the 28-joint Disease Activity Score (DAS28), Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI). Results Most enrolled pts in this interim analysis (n=852) completed 52 wks of treatment. The mean age at BL was 54.1 y; 76.1% of pts were female, and the mean duration of RA was 7.8 y. Mean BL disease scores were 1.5 for HAQ-DI, 5.3 for DAS28 based on C-reactive protein (CRP), 35.8 for SDAI, and 33.4 for CDAI. Prior biologic DMARD exposure was 17.4%. Overall, 49.9% of enrolled pts utilized the PSP. Improvement in physical functioning was greater at all study time points in pts utilizing the PSP vs those who were non-PSP users, as reflected by mean decreases of 0.61 and 0.46, respectively, in HAQ-DI from BL to wk 52 ( P =0.07). More pts using the PSP achieved an MCID in the HAQ-DI vs non-PSP users (73.8% vs 67.2%) at wk 52 ( P =0.18). Significant changes ( P ≤0.005) from BL to wk 52 were observed for pts using the PSP vs non-PSP users in DAS28(CRP) (−2.88 vs −2.13), SDAI (−30.57 vs −21.65), and CDAI (−26.98 vs −20.75) scores. Study discontinuation rates were significantly ( P =0.003) lower among PSP users vs non-PSP users (20.0% vs 29.0%). Conclusions Interim data showed that, in pts with moderate to severe RA who initiated ADA, better improvement in functional and clinical outcomes was achieved in the PSP users vs the non-PSP users. Improvements were maintained at all time points and continued to increase throughout the study, most likely due to better adherence rates among PSP users. Acknowledgements AbbVie funded the study and the analysis, and approved the abstract for submission. Medical writing assistance was provided by Katherine Groschwitz and Michael Theisen of Complete Publication Solutions, LLC, and was supported by AbbVie. Disclosure of Interest F. Van den Bosch Consultant for: received speaker and/or consultancy fees from AbbVie, Celgene, Janssen, Novartis, Pfizer, and UCB, S. Wassenberg Grant/research support from: participated in phase 3 and phase 4 studies sponsored by AbbVie, Speakers bureau: received speakers honoraria of less than 5.000 € in the last 2 years from AbbVie; also received support, including speaker and/or consultancy fees and attendance at conferences, from Chugai, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, A. Ostor Grant/research support from: received support from (including attendance at conferences), undertakes clinical trials and acts as a consultant to Roche, Chugai, MSD, AbbVie, Pfizer, Novartis, Napp, and BMS, N. Varothai Shareholder of: AbbVie, Employee of: AbbVie, V. Garg Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie

Background The Juvenile Arthritis Disease Activity Score (JADAS) is increasingly accepted for defining a treat-to-target strategy in patients (pts) with juvenile idiopathic arthritis (JIA)1 Objectives To use JADAS to evaluate clinical disease activity/control, with or without functional control, in pts with polyarticular or polyarticular-course JIA (pJIA), following the initiation of adalimumab (ADA) ± concurrent methotrexate (MTX) treatment. To assess the feasibility of JADAS definition of remission (REM) and minimal disease activity (MDA) as part of a treat-to-target strategy. Methods Data for this post hoc analysis originated from M10-444, an open-label study in pJIA pts 2 to Results Out of 32 pts, 25 (78%) had received prior MTX and 27/32 (84%) received concomitant MTX during the study. At baseline, pts had a mean JADAS10 of 18.8, JADAS27 of 19.0, and DI-CHAQ of 1.2. After 12 wks on open-label ADA, improvements were observed in clinical and functional outcomes. At wks 12 and 24, the mean JADAS10 was 6.2 and 5.3; mean JADAS27 was 6.4 and 5.6; mean DI-CHAQ was 0.7 and 0.7, respectively. No pts were in REM/MDA at baseline; however after 12 and 24 wks, a sizeable proportion achieved disease control (table). After 12 and 24 wks of ADA treatment, the proportions of pts achieving both, disease control and DI-CHAQ Conclusions Addition of open-label ADA treatment resulted in clinically important improvements in clinical and functional outcomes in pts with pJIA. JADAS 10 and -27 gave comparable results. JADAS REM and MDA are achievable targets with ADA treatment. References Consolaro et al, Arth & Rheum. 2012. Acknowledgements AbbVie sponsored the study, participated in the design, data collection, analysis, and interpretation; and in the writing of the final version. Medical writing support was provided by Naina Barretto, PhD, of AbbVie Disclosure of Interest D. Kingsbury Grant/research support from: AbbVie, P. Quartier Grant/research support from: AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, and Swedish Orphan Biovitrum, Consultant for: AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, and Swedish Orphan Biovitrum, G. Horneff Grant/research support from: AbbVie, Pfizer, Roche, Speakers bureau: AbbVie, Novartis, Pfizer, and Roche, K. Minden Grant/research support from: Pfizer and Abbvie, Consultant for: Pfizer, Abbvie, Roche and Pharm-Allergan, M. Toth: None declared, N. Varothai Employee of: AbbVie, A. Cardoso Employee of: AbbVie, J. Kalabic Employee of: AbbVie

Background Patients (pts) with rheumatoid arthritis (RA), who achieve clinical disease remission by treatment with disease-modifying agents may have residual joint inflammation and vascularization, which can be detected by Power Doppler (PD) ultrasonography. The aim of this analysis was to evaluate the proportion of RA pts with PD activity, 24 weeks (wks) after the addition of adalimumab (ADA) to methotrexate (MTX). Methods MUSICA (NCT01185288), a 24 wk double-blind, randomized, controlled trial evaluated the efficacy of 2 different dosages of MTX (7.5 or 20 mg/wk) plus ADA (40 mg every other wk) in RA pts with inadequate response to MTX. For this analysis, the MTX dosage groups were combined. Synovial vascularization was assessed by PD US at 10 joints (bilateral dorsal and volar views of metacarpophalangeal joints 2, 3, 5; dorsal images alone of metatarsophalangeal joint 5 and wrists), at baseline (BL), wks 4, 8, 12, 16, 20 and 24. Images were scored by ultrasound-experienced rheumatologists using a semi-quantitative 4-grade scale. Joint swelling was assessed for the same 10 joints (SJC10). Disease activity was assessed by 28-joint count disease activity score using C-reactive protein (DAS28[CRP]) (remission 26). Pearson9s coefficient (ρ) was used to assess correlation between continuous variables. Results After 24 wks of treatment with ADA +MTX, 44/309 pts (14%) were in DAS28(CRP) remission (mean PD score, 3.3); 18/309 (5.8%) pts were in SDAI remission (mean PD score, 2.7). At wk 24, for the 10 joints selected, 30/44 (68%) of pts in DAS28(CRP) remission had positive PD scores, while only 15 pts (34%) had ≥1 swollen joint, and only 6 pts (13.6%) had ≥1 tender joint. Ten out of 18 (55%) pts in SDAI remission had a positive PD score, while none had swollen/tender joints. A poor correlation (ρ Conclusions In agreement with other studies, residual joint inflammation was detected by PD US in pts in clinical remission; therefore ultrasound can offer additional information to that obtained from clinical disease measures. Acknowledgements AbbVie sponsored the study (NCT01185288), contributed to its design, participated in the collection, analysis, and interpretation of the data, and in the writing, reviewing, and approval of the final version. Medical writing support was provided by Naina Barretto, Ph.D., of AbbVie. Disclosure of Interest G. Kaeley Consultant for: AbbVie, M. Nishio Speakers bureau: AbbVie, J. Goyal Consultant for: AbbVie, D. MacCarter Consultant for: AbbVie, Speakers bureau: AbbVie, A. Wells Consultant for: AbbVie, A. Cardoso Employee of: AbbVie, S. Liu Employee of: AbbVie, J. Kalabic Employee of: AbbVie, H. Kupper Employee of: AbbVie

Background Juvenile idiopathic arthritis (JIA) is one of the most common childhood rheumatic diseases. Adalimumab (ADA) is approved for moderate to severe polyarticular JIA (pJIA) in patients (pts) ≥4 yrs in Australia and Japan and for pts ≥2 yrs in the US and EU. Objectives To evaluate long-term safety and effectiveness of ADA in pts with moderately to severely active pJIA who are prescribed and treated with ADA in routine clinical practice. Methods This is an ongoing, multicenter, non-interventional, observational registry of pts with moderately to severely active pJIA who are treated with either ADA ± methotrexate (MTX) or MTX alone as part of their routine clinical care. 800 pts (500 ADA/300 MTX) were to be enrolled in the US, EU, and Australia. The follow-up observational period is 10 yrs from enrollment into one of the treatment arms. Observational adverse events (AEs) were recorded from the first day in the registry through last contact, irrespective of registry treatment duration. Clinical outcomes were assessed by 27-joint juvenile arthritis disease activity score (JADAS27), based on CRP. 5 yr interim data are presented. Results As of January 2014, enrollment is complete. 842 pts (540 ADA/302 MTX) were treated as of the March 28, 2014 cutoff. Mean pJIA disease duration at enrollment was 1.3 and 3.7 yrs and mean duration of study exposure was 643 and 653 days for MTX and ADA arms, respectively. Baseline mean AJC73 was 5.8 and 5.4 for MTX and ADA, respectively, and CHAQ-DI was 0.6 for both groups. Overall, 153 pts (50.7%) in the MTX arm and 132 pts (24.4%) in the ADA arm discontinued registry drug. Of those, 22 (7.3%) and 23 (4.3%) in the MTX and ADA arm, respectively, discontinued due to an AE, and 39 of the 153 pts in the MTX arm discontinued as they switched to the ADA arm. The observational AEs are summarized (Table). No deaths, malignancies, or opportunistic infections were reported. In the ADA arm, there were 13 (2.4%) pts with serious infectious AEs (abdominal abscess, acute tonsillitis, appendicitis, cellulitis, gastroenteritis, mononucleosis, viral meningitis, pneumonia, pyelonephritis, scarlet fever, subcutaneous abscess, tonsillitis, urinary tract infection, and varicella). Frequencies and rates of treatment-emergent AEs were similar to those reported for observational AEs. Mean JADAS27 improved from 12.1 at baseline to 9.4, 6.1, 5.1, 4.4 at months 1, 3, 6, and 12 for pts in the MTX arm and from 12.1 at baseline to 7.4, 5.5, 4.4, 4.5 in the ADA arm, respectively (observed data). Conclusions Overall, ADA is well-tolerated in these pts with active pJIA. No new safety signals were observed, and based on this interim analysis, the known safety profile of ADA remains unchanged. Acknowledgements AbbVie sponsored the study (NCT00783510), contributed with PRINTO and PRCSG to the design, and participated in data collection, analysis, and interpretation, and in the writing, review, and approval of the abstract. Medical writing support was provided by Jessica L. Suboticki, PhD, of AbbVie. Disclosure of Interest N. Ruperto Employee of: GASLINI Hospital, which has received contributions to support the research activities of the network of PRINTO from AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., “Francesco Angelini”, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Pharmaceuticals. NR has served on speaker9s bureau for Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, Janssen Biologics B.V., MedImmune, Roche, and Wyeth/Pfizer, H. Brunner Consultant for: AbbVie Inc., AstraZeneca, Centocor, Bristol-Myers Squibb, Boehringer-Ingelheim, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UCB, and Genentech, Speakers bureau: Genentech Pharmaceuticals, C. Wallace Grant/research support from: Pfizer, Amgen, Consultant for: Amgen, Novartis, M. Toth: None declared, I. Foeldvari Consultant for: AbbVie, Novartis, J. Bohnsack Consultant for: Novartis, D. Milojevic Consultant for: Genentech, Novartis, E. Rabinovich Grant/research support from: UCB Pharma, Janssen Research & Development, LLC, Hoffmann-La Roche Inc., AbbVie, P. Vavrincova: None declared, D. Kingsbury Grant/research support from: AbbVie, K. Marzan Grant/research support from: AbbVie, P. Quartier Grant/research support from: AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, Swedish Orphan Biovitrum; Participates on a data management committee of a phase 3 trial by Sanofi, Consultant for: AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, Swedish Orphan Biovitrum, K. Minden Grant/research support from: Pfizer, Abbvie, Consultant for: Pfizer, Abbvie, Roche/Chugai, Novartis, Medac, Pharm-Allergan, Speakers bureau: Pfizer, Abbvie, Roche/Chugai, Novartis, Medac, Pharm-Allergan, E. Chalom Speakers bureau: AbbVie, G. Horneff Grant/research support from: AbbVie, Pfizer, and Roche and speaker9s fees from AbbVie, Novartis, Pfizer, Roche, R.-M. Kuester Grant/research support from: AbbVie, Wyeth/Pfizer, J. Dare Grant/research support from: AbbVie, AstraZeneca, Bristol-Myers Squibb, Horizon Pharma, Medac GmbH, UCB Biosciences, M. Bereswill Shareholder of: AbbVie, Employee of: AbbVie, H. Kupper Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie, A. Martini Employee of: GASLINI Hospital, which has received contributions to support the research activities of the network of PRINTO from AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., “Francesco Angelini”, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, Wyeth Pharmaceuticals, Speakers bureau: Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, MedImmune, D. Lovell Consultant for: AbbVie Inc., AstraZeneca, Centocor, Bristol-Myers Squibb, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UBC, Xoma, Genentech; served on data and safety monitoring boards for Amgen, Forest Research, Speakers bureau: Wyeth Pharmaceuticals

Background The adalimumab (ADA) patient (pt) support program (PSP) is offered to pts with rheumatoid arthritis (RA). Evidence to understand factors affecting the use of PSPs is scarce. Objectives To assess predictors of ADA PSP utilization among RA pts who initiate ADA treatment. Methods This was a post hoc interim analysis of the Post-Marketing Observational Study to Determine the Effectiveness and Patient Satisfaction With Adalimumab Treatment in Patients With RA (PASSION; NCT01383421). In this multi-country, ex-US study, the PSP includes “Core elements” (starter pack, call center/hotline, nursing services, educational material, and injection guide; offered in all participating countries) and “other elements” (eg, refill reminders, email, newsletters, support groups, home delivery, and financial assistance; vary by country). PSP utilization (yes/no) was a dependent variable in a multivariate logistic regression model examining the following potential predictors of using the ADA PSP: baseline (BL) Patient Activation Measure-13 (PAM-131; evaluates knowledge, skills, and confidence essential to a pt managing his/her own health; scores classified a priori into 4 levels [higher level means greater pt involvement in disease management]), age, sex, race, RA disease duration, prior use of biologic disease-modifying anti-rheumatic drug (DMARD), Health Assessment Questionnaire Disability Index (HAQ-DI), BL Simplified Disease Activity Index (SDAI), and BL 28-joint Disease Activity Score based on C-reactive protein (DAS28(CRP)). Results Most enrolled pts were female and white (Table); BL characteristics were similar across the 4 PAM-13 levels. Overall, 427 of enrolled pts (51%) utilized the PSP, including 40%, 53%, 52%, and 58% of pts in PAM-13 Levels 1–4, respectively. Pts utilizing Core PSP elements but not other elements (n=93) included 19%, 14%, 9%, and 5% of pts in PAM-13 Levels 1–4, respectively. The percentages of pts utilizing both Core and Other PSP elements (n=292) increased with PAM-13 level and included 19%, 32%, 37%, and 48% of pts in PAM-13 Levels 1–4, respectively, suggesting greater overall PSP usage by pts in higher PAM-13 levels. Pts in Level 4 had the highest use for all Core PSP elements, including ADA call center (39%), educational material (41%), material regarding ADA (41%), ADA injection guide (39%), starter pack (32%), and nursing services (32%). Predictors favoring PSP use among observed RA pts included PAM-13 level (odds ratio [OR] per 1-level increase, 1.32; 1.12–1.55), white race (OR, 3.83; 95% CI, 2.04–7.20), prior use of biologic DMARDs (OR, 2.31; 95% CI, 1.46–3.65), BL HAQ-DI (OR, 1.37; 95% CI, 1.05–1.79), and BL DAS28(CRP) (OR, 1.18; 95% CI, 1.02–1.38). Female sex was a predictor for not using the PSP (OR, 0.62; 95% CI, 0.42–0.92) in this mostly female population. Conclusions In pts with moderate to severe RA treated per standard of care, white race, prior biologic use, and BL disease parameters were positive predictors favoring PSP use. References Hibbard JH, et al. Health Serv Res. 2004;39(4 Pt 1):1005-1026. Acknowledgements AbbVie funded the study and the analysis, and approved the abstract for submission. Medical writing assistance was provided by Katherine Groschwitz and Michael Theisen of Complete Publication Solutions, LLC, and was supported by AbbVie. Disclosure of Interest F. Van Den Bosch Consultant for: received speaker and/or consultancy fees from AbbVie, Celgene, Janssen, Novartis, Pfizer, and UCB, S. Wassenberg Grant/research support from: participated in phase 3 and phase 4 studies sponsored by AbbVie, Speakers bureau: received speakers honoraria of less than 5.000 € in the last 2 years from AbbVie; also received support, including speaker and/or consultancy fees and attendance at conferences, from Chugai, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, A. Ostor Grant/research support from: received support from (including attendance at conferences), undertakes clinical trials and acts as a consultant to Roche, Chugai, MSD, AbbVie, Pfizer, Novartis, Napp, and BMS, N. Varothai Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie, V. Garg Shareholder of: AbbVie, Employee of: AbbVie

Background Control of disease activity in patients with rheumatoid arthritis (RA) has become achievable using synthetic and biologic disease modifying anti-rheumatic drugs, both as monotherapy or in combination. However, residual inflammatory disease can be revealed by sensitive imaging techniques such as ultrasonography in patients with remission of disease activity. Objectives To evaluate ultrasonographic vascularity changes in the joints of RA patients with previous methotrexate (MTX) inadequate-response upon initiation of adalimumab (ADA) combination therapy with two different doses of MTX. Methods MUSICA was a double-blind, randomized, controlled trial evaluating the efficacy of 2 different dosages of MTX (7.5 or 20 mg/wk) in combination with ADA (40 mg every other wk) for 24 wks in RA patients with previous inadequate response to MTX. Dorsal and volar Power Doppler (PD) images of bilateral metacarpophalangeal (MCP) joints 2, 3, 5, and dorsal images alone of metatarsophalangeal joint 5 (MTP5) and wrists were scored by 2 of 4 independent ultrasound-experienced rheumatologists using a semi-quantitative 4-grade scale. Patients with baseline and wk-24 ultrasonographic images were subgrouped based on 28-joint count disease activity score using C-reactive protein (DAS28[CRP] Results After 24-wk treatment of ADA with 7.5 or 20 mg/wk MTX, rapid decreases in mean synovial vascularity were observed regardless of achievement of disease control, with most improvement occurring within the first 4 wks. The wrist had the most baseline PD activity, 1.6 out of 6. Improvements in vascularity were greatest in MCP2 (-0.5), MCP3 (-0.4), and wrist (-0.4) after 24 wks of ADA + MTX treatment. Dorsal and volar PD vascularity incidence and activity were similar in MCP2, but differed in MCP3 and MCP5 where dorsal imaging encompassed most activity. After 24 wks of ADA + MTX, mean vascularity of the bilateral 5-joint composite score was lowest in patients that achieved DAS28 (CRP) Conclusions Upon initiating ADA in MTX inadequate-responders, rapid reduction in joint vascularity was observed in many patients, regardless of MTX dose. Low overall baseline ultrasonographic vascularity values may have partially reflected suppression of inflammation due to prior MTX treatment. Improvements in vascularity in patients were observed irrespective of achieving low disease activity or remission with a numeric trend for lower mean vascularity in patients achieving lower disease activity. Acknowledgements AbbVie sponsored the study (NCT01185288), contributed to its design, participated in the collection, analysis, and interpretation of the data, and in the writing, reviewing, and approval of the final version. Statistical support was provided by Shufang Liu, Ph.D., of AbbVie. Medical writing support was provided by Douglas E. Dylla, Ph.D., of AbbVie. Disclosure of Interest G. Kaeley Consultant for: AbbVie, M. Nishio Speakers bureau: AbbVie, J. Goyal Consultant for: AbbVie, D. MacCarter Consultant for: AbbVie, Speakers bureau: AbbVie, A. Wells Consultant for: AbbVie, A. Cardoso Shareholder of: AbbVie, Employee of: AbbVie, S. Chen Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie, H. Kupper Shareholder of: AbbVie, Employee of: AbbVie DOI 10.1136/annrheumdis-2014-eular.1389

Background Adalimumab (ADA) has been shown to be safe and effective in polyarticular juvenile idiopathic arthritis (pJIA), and is approved for use in moderate to severe pJIA patients (pts) ≥4 years (yrs) in the US, Australia, and Japan, and in the EU for pts ≥2 yrs. Objectives Pts with pJIA are candidates for routine childhood vaccinations, according to the respective national guidelines. This post hoc report describes the observed use of vaccines in pJIA pts receiving ADA in 3 clinical trials and one registry. Methods Pts with active pJIA were enrolled in one of the following trials: M10-444 (ages 2 to Results A summary of all vaccinations is presented in the Table. Among the different types of vaccines, the influenza vaccine was the most frequently administered: 55, 63, 10 and 22 influenza vaccines were administered in DE038, M10-240, M10-444 and P10-262, respectively. In addition, pneumococcal, human papilloma virus, diphtheria, tetanus and/or pertussis, hepatitis A and B, and polio vaccines were administered. 2 pts each received >5 vaccinations in DE038 and M10-240, while 3 pts each in M10-444 and P10-262 received >1 but Conclusions These data support the idea that pJIA pts treated with ADA can be immunized with routine, inactive, preventative vaccines, such as the influenza vaccine. However, not all of the eligible pts were vaccinated on time according to the Centers of Disease Control (CDC) recommendations, and many pts were not vaccinated at all suggesting that physicians may be reluctant to use vaccines in children receiving antirheumatic therapies. Further investigation regarding rheumatologists9 vaccination practices for pts with JIA is warranted. Acknowledgements AbbVie sponsored the studies (NCT00774537, NCT00690573, NCT00048542 and NCT00783510), contributed to the study design, and participated in collection, analysis, and interpretation of data, and in writing, reviewing, and approval of the final version. Medical writing support was provided by Jessica L. Suboticki, PhD, and Naina Barretto, PhD, of AbbVie. Disclosure of Interest K. Minden Grant/research support: Pfizer, AbbVie, Inc., Consultant for: Pfizer, AbbVie, Roche/Chugai, Novartis, Medac and Pharm-Allergan, Speakers bureau: Pfizer, abbVie, Roche/Chugai, Novartis, Medac and Pharm-Allergan, M. Karunaratne Shareholder of: AbbVie, Inc., Employee of: AbbVie, Inc., H. Kupper Shareholder of: AbbVie, Inc., Employee of: AbbVie, Inc., J. Kalabic Shareholder of: AbbVie, Inc., Employee of: AbbVie, Inc. DOI 10.1136/annrheumdis-2014-eular.1559