Randi Bonin

Symptomatic Efficacy of Etanercept and Its Effects on Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Trial

To assess the efficacy of etanercept in the treatment of early active nonsteroidal antiinflammatory drug (NSAID)–refractory nonradiographic axial spondyloarthritis (SpA).

Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study

Objective To evaluate the efficacy and safety of etanercept (ETN) after 48 weeks in patients with early active non-radiographic axial spondyloarthritis (nr-axSpA). Methods Patients meeting Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA, but not modified New York radiographic criteria, received double-blind ETN 50 mg/week or placebo (PBO) for 12 weeks, then open-label ETN (ETN/ETN or PBO/ETN). Clinical, health, productivity, MRI and safety outcomes were assessed and the 48-week data are presented here. Results 208/225 patients (92%) entered the open-label phase at week 12 (ETN, n=102; PBO, n=106). The percentage of patients achieving ASAS40 increased from 33% to 52% between weeks 12 and 48 for ETN/ETN and from 15% to 53% for PBO/ETN (within-group p value <0.001 for both). For ETN/ETN and PBO/ETN, the EuroQol 5 Dimensions utility score improved by 0.14 and 0.08, respectively, between baseline and week 12 and by 0.23 and 0.22 between baseline and week 48. Between weeks 12 and 48, MRI Spondyloarthritis Research Consortium of Canada sacroiliac joint (SIJ) scores decreased by −1.1 for ETN/ETN and by −3.0 for PBO/ETN, p<0.001 for both. Decreases in MRI SIJ inflammation and C-reactive protein correlated with several clinical outcomes at weeks 12 and 48. Conclusions Patients with early active nr-axSpA demonstrated improvement from week 12 in clinical, health, productivity and MRI outcomes that was sustained to 48 weeks. Trial registration number NCT01258738.

Evaluation of Health Outcomes with Etanercept Treatment in Patients with Early Nonradiographic Axial Spondyloarthritis

Objective. Analyses were conducted to examine the baseline burden of illness and compare the effect of etanercept (ETN) versus placebo (PBO) on quality of life (QOL) in patients with nonradiographic axial spondyloarthritis (nr-axSpA) who failed nonsteroidal antiinflammatory drugs (NSAID). Methods. Patients fulfilling the Assessment of Spondyloarthritis International Society axSpA criteria, not meeting the modified New York criteria for ankylosing spondylitis (AS), who were symptomatic 3 months to 5 years, with a Bath AS Disease Activity Index score ≥ 4, and failed ≥ 2 NSAID were randomized to ETN 50 mg weekly or PBO (double-blind) for 12 weeks, followed by open-label ETN 50 mg for 92 weeks. Stable NSAID were allowed throughout our study. QOL outcomes over 24 weeks were analyzed using ANCOVA models. Results. At baseline, Multidimensional Fatigue Inventory (MFI; ETN mean 14.7, PBO mean 15.0), EQ-5D utility (0.52, 0.57), EQ-5D visual analog scale (56.5, 56.4), and Medical Outcomes Study (MOS) Sleep Index II (45.5, 48.1) were worse than population norms (6.6–8.0, 0.86, 82.5, and 25.8, respectively). At Week 12, Bath AS Patient Global Score, nocturnal and average back pain, MOS Short Form-36 (SF-36) physical component, and Work Productivity and Activity Index (WPAI) presenteeism and activity impairment favored ETN (p < 0.05). Nonsignificant improvements for ETN were seen in other WPAI domains, MFI, MOS-Sleep Index I and II, Hospital Anxiety and Depression Scale, EQ-5D utility score, and SF-36 mental component (p > 0.05). At Week 24, patients in the PBO group who had switched to ETN at Week 12 showed improvement in most QOL assessments, similar to that seen in patients receiving ETN for 24 weeks. Conclusion. Improvements favored ETN in QOL and productivity measures, with limited improvement on general QOL measures. Short disease duration, a short PBO-controlled period, and a wide range of QOL scores at baseline may have influenced improvements.

Effects of Long‐Term Etanercept Treatment on Clinical Outcomes and Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: 104‐Week Results From a Randomized, Placebo‐Controlled Study

To evaluate the long‐term clinical and imaging efficacy of etanercept in patients with early, active nonradiographic axial spondyloarthritis (SpA).

Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis

Objective To compare 2 years of radiographic sacroiliac joint (SIJ) changes in patients with recent onset axial spondyloarthritis (axSpA) receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR). Methods Endpoints were changes at week 104 per the modified New York (mNY) grading system in total SIJ score (primary endpoint) and net percentage of patients with progression defined three ways. Treatment effect was analysed with and without adjustment for baseline covariates. Results At 104 weeks, total SIJ score improved in the etanercept group (n=154, adjusted least-squares mean change: –0.14) and worsened in the control group (n=182, change: 0.08). The adjusted difference between groups (etanercept minus control) was –0.22 (95% CI –0.38 to –0.06), p=0.008. The net percentage of patients with progression was significantly lower in the etanercept versus the control group for two of three binary endpoints: –1.9% versus 1.6% (adjusted difference for etanercept minus control: –4.7%,95% CI –9.9 to 0.5, p=0.07) for change in mNY criteria; –1.9% versus 7.8% (adjusted difference: –18.2%,95% CI –30.9 to –5.6, p=0.005) for change ≥1 grade in ≥1 SIJ; and –0.6% versus 6.7% (adjusted difference: –16.4%,95% CI –27.9 to –5.0, p=0.005) for change ≥1 grade in ≥1 SIJ, with shift from 0 to 1 or 1 to 0 considered no change. Conclusion Despite the slow radiographic SIJ progression rate over 2 years in axSpA, this study suggests a lower rate of progression in the SIJ with etanercept than without anti-tumour necrosis factor therapy. Trial registration numbers NCT01258738, NCT01648907; Post-results.

Effects of Long-term Etanercept Treatment on Clinical Outcomes and Objective Signs of Inflammation in Early Non-Radiographic Axial Spondyloarthritis: 104-Week Results From the EMBARK Study

To evaluate the long‐term clinical and imaging efficacy of etanercept in patients with early, active nonradiographic axial spondyloarthritis (SpA).

SAT0405 No Radiological Sacroiliac Joint Progression after 2 Years of Etanercept Treatment in Non-Radiographic Axial Spondyloarthritis: Data from The Embark Study

Background Radiological structural changes in the sacroiliac joint (SIJ) over time in non-radiographic axial spondyloarthrits (nr-axSpA) can be evaluated by measuring the progression from non-radiographic to radiographic damage status according to modified New York (mNY) criteria but also with other more sensitive methods.1,2 However, the question remains whether anti-tumor necrosis factor therapy can prevent this structural progression, particularly in patients with nr-axSpA. Objectives To evaluate radiographic progression in SIJ after 2 years of etanercept (ETN) treatment in nr-axSpA according to different outcome measures. Methods Study design: 104-week follow-up of patients enrolled in the EMBARK trial who received ETN either from baseline (active treatment arm) or week 12 (placebo [PBO] arm). Patients: Active nr-axSpA refractory to ≥2 NSAIDs. Study drug: ETN 50 mg once a week. Outcome measures: Pelvic X-rays were performed at both baseline and week 104. After anonymization, 3 trained readers evaluated the films blinded to chronology using the 0–4 grade scale of the mNY radiographic criteria for each (left and right) SIJ. Statistical analysis: X-rays from patients who completed the 104-week study were assessed. For continuous variables (e.g., total score from 0 to 8 for the left and right SIJ according to mNY grading), the mean score from the 3 readers was evaluated (bias was possible because readers knew that all patients were previously considered to have nr-axSpA); for binary variables (e.g., change from non-radiographic to radiographic axSpA, worsening of ≥1 grade in ≥1 SIJ and an absolute final value of ≥2 in the worsened joint), the score agreed upon by ≥2 readers was used for analysis. Results Of 215 randomized patients, 169 completed the open-label period at 104 weeks; 161 patients had X-rays available at both baseline and week 104. Only 1 patient was found to have satisfied mNY criteria for radiographic SIJ damage (ie, at least bilateral grade II or unilateral grade III) at baseline. Of 160 patients with mNY negative scores at baseline, none became mNY positive at week 104. The mean score (SD) for the total (left and right) SIJ (scale, 0–8) was 0.87 (0.83) at baseline and 0.88 (0.85) at week 104 (change, 0.01 [0.15]; P=0.386). No patients had both worsening of ≥1 grade in ≥1 SIJ and an absolute final value of ≥2 in the worsened joint. Conclusions This study suggests that, whatever the outcome measure, no structural radiological progression in the SIJ occurred after 2 years of etanercept treatment in patients with nr-axSpA. Given this studys limitations, eg, lack of controls and inclusion of completers only, it is unclear whether this is an effect of etanercept. Additional studies using X-rays and MRI of the SIJ should be conducted to further address this question. References Van der Linden S, et al. Arthritis Rheum. 1984;27:361–8. Dougados M, et al. Arthritis Rheum. 2014;66(suppl 11):S234–5. Disclosure of Interest M. Dougados Grant/research support from: Pfizer, AbbVie, UCB, Merck, Eli-Lilly, Sanofi, Consultant for: Pfizer, AbbVie, UCB, Merck, Eli-Lilly, Sanofi, W. Maksymowych Grant/research support from: AbbVie, Consultant for: AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Janssen Pharmaceutica, L.P, Pfizer, UCB, D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Daiichi, Eli-Lilly, Galapagos, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, Employee of: Director of Imaging Rheumatology bv., R. Pedersen Shareholder of: Pfizer, Employee of: Pfizer, R. Bonin Shareholder of: Pfizer, Employee of: Pfizer, I. Logeart Shareholder of: Pfizer, Employee of: Pfizer, J. Bukowski Shareholder of: Pfizer, Employee of: Pfizer, H. Jones Shareholder of: Pfizer, Employee of: Pfizer

THU0382 Change in sacroiliac joint structural radiographic damage after two years of etanercept therapy in comparison to a contemporary control cohort in non-radiographic axial spondyloarthritis

Background Despite the well-known symptomatic and anti-inflammatory effect of TNF inhibitors in axial SpA (axSpA), demonstrating a structural effect is challenging. Objectives To compare 2 yrs of radiographic sacroiliac joint (SIJ) changes in pts receiving etanercept (ETN) in a clinical trial to similar pts not receiving biologics in a cohort study. Methods Pts had recent onset non-radiographic (nr)-axSpA fulfilling ASAS criteria. Study group: pts receiving ETN 50 mg once weekly for 2 yrs in EMBARK (NCT01258738). Control group: pts in an ongoing longitudinal cohort study not receiving biologics for 2 yrs (DESIR, NCT01648907). Outcome measure: change in x-ray SIJ score per mNY criteria (0–4 per SIJ). X-rays were read by 3 experienced readers unaware of image chronology and pt group. Primary endpoint: change (mean of 3 readers) in total SIJ score (-8 to +8). Binary endpoints: (1) shift from baseline (BL) mNY+ to wk-104 mNY- and vice versa; (2) change in SIJ score ≥1 (left or right SIJ); (3) change in SIJ score ≥1 in ≥1 SIJ, with change from 0 to 1 and from 1 to 0 considered no change. Treatment effect was analyzed without and with adjustment for the baseline (BL) covariates of sex, symptom duration, smoking status, HLA-B27 status, ASDAS-CRP, SPARCC MRI SIJ score, and SIJ radiography score. Results At BL, the control (DESIR, N=197) and ETN (EMBARK, N=164) cohorts differed significantly in all covariates listed above. The difference in change in total SIJ score for control vs ETN, adjusted for covariates, was small but significant: least-squares mean (95% CI): 0.08 (-0.03, 0.20) vs -0.14 (-0.26, -0.01); p=0.008. The table presents x-ray changes. When adjusted for covariates, the mean difference between control and ETN was significant for 2 of the 3 binary endpoints (table).Table 1. Observed Radiographic Changes from BL to Week 104 Endpoint Cohort Improved Worsened Mean Difference* Mean differences (Control − ETN) n/N (%) n/N (%) (95% CI)† (95% CI) mNY criteria Control 3/193 (1.6) 6/193 (3.1) 1.6% (-1.5, 4.6) 3.4% (-0.7, 7.5)† ETN 4/161 (2.5) 1/161 (0.6) -1.9% (-4.6, 0.9) 4.7% (-0.5, 9.9)‡ Δ ≥1 grade in ≥1 SIJ Control 21/193 (10.9) 36/193 (18.7) 7.8% (0.1, 15.4) 9.6% (-0.9, 20.2)† ETN 19/161 (11.8) 16/161 (9.9) -1.9% (-9.1, 5.4) 18.2% (5.6, 30.9)‡§ Δ ≥1 grade in ≥1 SIJ; Δ from 0 to 1 and 1 to 0 considered no Δ Control 16/193 (8.3) 29/193 (15.0) 6.7% (-0.1, 13.5) 7.4% (-2.1, 16.8)† ETN 15/161 (9.3) 14/161 (8.7) -0.6% (-7.2, 6.0) 16.4% (5.1, 27.8)‡§ Based on 2 of 3 readers assigning same category; otherwise considered no change. Some patients started with lowest possible score and could not improve. Δ, change. *Percent pts with worsening − percent pts with improvement. †One-way ANOVA. ‡Adjusted for covariates listed in Methods. §P=0.005. Conclusions This analysis confirms the slow rate of radiographic SIJ progression over 2 yrs in nr-axSpA. The observed data suggest a lower rate of progression with ETN than without a TNF inhibitor. Disclosure of Interest M. Dougados Grant/research support from: Pfizer, Abbvie, UCB, Merck, Lilly, Sanofi, Consultant for: Pfizer, Abbvie, UCB, Merck, Lilly, Sanofi, W. P. Maksymowych Grant/research support from: AbbVie, Pfizer, Sanofi, Consultant for: AbbVie, Amgen, Eli Lilly, Janssen Pharmaceutica, L.P, Novartis, Pfizer, Sanofi, UCB, R. Landewe Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB, Wyeth, Consultant for: Abbott/Abbvie, Ablynx, Amgen, Astra-Zeneca, BMS, Celgene, Janssen (formerly Centocor), Galapagos, GSK, Novartis, Novo-Nordisk, Merck, Pfizer, Roche, Schering-plough, TiGenix, UCB, Wyeth, Employee of: Is a director of Rheumatology Consultancy BV, A. Molto Grant/research support from: Pfizer, UCB, Consultant for: Abbvie, BMS, MSD France- Merck, Pfizer, UCB, P. Claudepierre Grant/research support from: Pfizer, Roche-Chugai, MSD, Consultant for: Abbvie, BMS, Celgene, Janssen, Novartis, Merck, Pfizer, Roche, UCB, M. de Hooge: None declared, R. G. Lambert Consultant for: Bioclinica, R. Bonin Shareholder of: Pfizer, Employee of: Pfizer, J. Bukowski Shareholder of: Pfizer, Employee of: Pfizer, H. Jones Shareholder of: Pfizer, Employee of: Pfizer, I. Logeart Shareholder of: Pfizer, Employee of: Pfizer, R. Pedersen Shareholder of: Pfizer, Employee of: Pfizer, A. Szumski Employee of: InVentiv Health, B. Vlahos Shareholder of: Pfizer, Employee of: Pfizer, D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boeringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, UCB, Employee of: Director of Imaging Rheumatology bv.

THU0353 Change in mri structural lesions in the sacroiliac joint after two years of etanercept therapy in comparison to a contemporary control cohort in non-radiographic axial spondyloarthritis

Background Demonstrating a structural effect of TNF inhibitors in axial SpA (axSpA) is challenging. Objectives To compare 2 yrs of structural lesion changes on T1W MRI in the sacroiliac joints (SIJ) of pts receiving etanercept (ETN) in a clinical trial to similar pts not receiving biologics in a cohort study. Methods Pts had recent onset non-radiographic (nr)-axSpA fulfilling ASAS criteria. Study group: pts receiving ETN 50 mg once weekly for 2 yrs in EMBARK (NCT01258738). Control group: pts in a longitudinal cohort study not receiving biologics for 2 yrs (DESIR, NCT01648907). Outcome measure: change in structural lesions of erosion, backfill, fat metaplasia, and ankylosis. MRI images were read by 3 experienced readers unaware of image chronology and pt group, using the SpondyloArthritis Research Consortium of Canada SIJ Structural Score (SSS).1 For each group, differences were calculated between percentages of patients experiencing increases and decreases in structural lesion scores over 2 yrs. Treatment effect was analyzed without and with adjustment for the baseline (BL) covariates of sex, symptom duration, smoking status, HLA-B27 status, ASDAS-CRP, SPARCC MRI SIJ score, and SIJ radiography score. Results At BL, pts with MRI images in the control (DESIR, N=76) and ETN (EMBARK, N=162) cohorts differed significantly in symptom duration, smoking status, ASDAS-CRP and SPARCC MRI SIJ score. The table presents structural lesion changes on MRI. The mean difference between control and ETN was significant for erosion (table). Figure shows cumulative probability plot.Table 1. Observed Change in MRI SIJ Structural Lesions, BL to Week 104 Structural lesion Cohort Decreased Increased Mean Difference* Mean differences (Control − ETN) n/N (%) n/N (%) (95% CI)† (95% CI) Erosion Control 14/76 (18.4) 10/76 (13.2) -5.3% (-18.1, 7.6) 18.8% (3.5, 34.1)†§ ETN 46/162 (28.4) 7/162 (4.3) -24.1 (-32.1, -16.0) 17.8% (2.1, 33.6)‡§ Backfill Control 2/76 (2.6) 10/76 (13.2) 10.5% (1.7, 19.3) -5.5% (-16.6, 5.5)† ETN 1/162 (0.6) 27/162 (16.7) 16.0% (10.1, 22.0) -3.7% (-15.2, 7.8)‡ Fat metaplasia Control 0/76 (0) 7/76 (9.2) 9.2% (2.6, 15.9) 1.8% (-6.6, 10.2)† ETN 2/162 (1.2) 14/162 (8.6) 7.4% (2.7, 12.2) -2.4% (-11.2, 6.4)‡ Ankylosis Control 0/76 (0) 1/76 (1.3) 1.3% (-1.3, 3.9) 1.3% (-2.2, 4.9)† ETN 2/162 (1.2) 2/162 (1.2) 0% (-2.4, 2.4) 1.5% (-3.1, 6.2)‡ Based on 2 of 3 readers assigning same category; otherwise considered no change. Some pts started with the lowest possible score and could not decrease. *Percent pts with increase – percent pts with decrease. †One-way ANOVA. ‡Adjusted for covariates listed in Methods. §P<0.05.Figure 1. Cumulative Probability of Change in MRI SIJ Erosion, BL to Week 104. Conclusions This analysis confirms the slow rate of structural lesion progression in the SIJ over 2 yrs in nr-axSpA and suggests a lower rate of progression with ETN than without a TNF inhibitor. References Maksymowych WP, et al. J Rheumatol. 2015;42:79–86. Disclosure of Interest W. P. Maksymowych Grant/research support from: AbbVie, Pfizer, Sanofi, Consultant for: AbbVie, Amgen, Eli Lilly, Janssen Pharmaceutica, L.P, Novartis, Pfizer, Sanofi, UCB, M. Dougados Grant/research support from: Pfizer, Abbvie, UCB, Merck, Lilly, Sanofi, Consultant for: Pfizer, Abbvie, UCB, Merck, Lilly, Sanofi, R. G. Lambert Consultant for: Bioclinica, R. Landewe Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB, Wyeth, Consultant for: Abbott/Abbvie, Ablynx, Amgen, Astra-Zeneca, BMS, Celgene, Janssen (formerly Centocor), Galapagos, GSK, Novartis, Novo-Nordisk, Merck, Pfizer, Roche, Schering-plough, TiGenix, UCB, Wyeth, Employee of: Is a director of Rheumatology Consultancy BV, which is registered company under Dutch law, A. Molto Grant/research support from: Pfizer, UCB, Consultant for: Abbvie, BMS, MSD France- Merck, Pfizer, UCB, P. Claudepierre Grant/research support from: Pfizer, Roche-Chugai, MSD, Consultant for: Abbvie, BMS, Celgene, Janssen, Novartis, Merck, Pfizer, Roche, UCB, M. de Hooge: None declared, R. Bonin Shareholder of: Pfizer, Employee of: Pfizer, J. Bukowski Shareholder of: Pfizer, Employee of: Pfizer, H. Jones Shareholder of: Pfizer, Employee of: Pfizer, I. Logeart Shareholder of: Pfizer, Employee of: Pfizer, R. Pedersen Shareholder of: Pfizer, Employee of: Pfizer, A. Szumski Employee of: InVentiv Health, B. Vlahos Shareholder of: Pfizer, Employee of: Pfizer, D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boeringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, UCB, Employee of: Director of Imaging Rheumatology bv.

SAT0372 Clinical and Imaging Efficacy of Etanercept in Early Non-Radiographic Axial Spondyloarthritis: 48-Week Treatment Data

Background Our previous data show that Etanercept (ETN) has superior clinical and anti-inflammatory efficacy to placebo (PBO) in patients with non-radiographic axial spondyloarthritis (nr-axSpA) and inadequate response to NSAIDs in a 12 week double-blind PBO controlled trial. Objectives To examine clinical and anti-inflammatory efficacy of ETN at wk 48 (12 wk double blind followed by 36 wk open-label treatment phase). Methods Patients with symptom duration >3 mths–<5 yrs, fulfilling ASAS axSpA criteria without meeting radiographic criteria for ankylosing spondylitis, having BASDAI ≥4, and failure with ≥2 NSAIDs were enrolled and randomized to ETN 50 mg QW or PBO. Both groups continued stable NSAID therapy. After 12 wks all patients received ETN 50 mg open-label. Clinical assessments (ASAS, ASDAS, BASDAI, BASFI) and MRI of sacroiliac (SI) joint and spine were performed (SPARCC and ASspiMRI scoring methods). Analyses used an ANCOVA model with baseline scores, treatment, MRI sacroiliitis +/-, as variables. Results Of 215 initially randomized patients (mITT population), 205 entered the open label phase (ETN=100; PBO=105). The proportion of patients achieving ASAS40 by 12 wks (primary endpoint) was 33.3% of those treated with ETN and 14.7% of PBO treated patients, improving to 52.7% of patients in the combined groups by wk 48. MRI-SI joint inflammation was reduced from baseline to wk12 in ETN and PBO treatment groups by 56.7% and 16.4%, respectively, and 65.2% (combined treatment groups) by wk 48. SAE caused 1 discontinuation (pyrexia) between wks 12–48 and infections (the most frequent AE) occurred in 43/208 patients. Table 1. Effects of ETN vs PBO in patients with nr-axSpA at wk 48 Endpoint Double-blind phase Open label phase Wk 12 Wk 48 ETN50 PBO Combined groups, all received ETN50 n=105** n=109** n=205** % patients achieving ASAS40-all patients 33.3 14.7 52.7 ASAS40-patients with elevated CRP 47.9 18.2 66.3 ASAS 5/6 34.3 11.9 47.3 BASDAI50 43.8 23.9 62.4 Baseline [N=215]* % Improvement from baseline Mean (SE) ASDAS-CRP (clinical improvement 1.1; major improvement 2.0) 3.0 (0.1) 42.2 21.3 54.5 BASDAI 6.0 (0.1) 39.3 27.9 55.8 BASFI 4.0 (0.2) 37.8 23.0 53.2 SPARCC 6 DVU score (0–108; MCID 5.0) 7.2 (0.7) 40.1 11.1 60.8 SPARCC SI joint score (0–72; MCID 2.5) 7.4 (0.8) 56.7 16.4 65.2 ASspiMRI 1.5 (0.2) 40.1 7.7 40.9 MCID, minimum clinically important difference. *Modified intention to treat population, includes PBO and ETN50 treatment groups. **May vary for the different outcomes. Conclusions In patients with early, active nr-axSpA and an inadequate response to ≥2 NSAIDs, clinical and imaging outcomes improved from baseline to a greater extent with etanercept therapy than with PBO, during the first 12 weeks. In the ensuing 36 week open label period, these outcomes continued to improve. There were no new safety signals. Acknowledgements The study NCT01258738 was funded by Pfizer Inc. Medical writing support was provided by Rachael Profit of Engage Scientific, Envision Pharma Group, and was funded by Pfizer Inc. Disclosure of Interest W. Maksymowych Grant/research support: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Janssen, Merck, Pfizer, Synarc, and UCB, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Janssen, Merck, Pfizer, Synarc, and UCB, Employee of: CaRE Arthritis Ltd, D. van der Heijde Grant/research support: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, Chugai, Daiichi, Eli Lilly, GlaxoSmithKline, Janssen Biologics, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, and Vertex, Consultant for: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, Chugai, Daiichi, Eli Lilly, GlaxoSmithKline, Janssen Biologics, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, and Vertex, Employee of: Imaging Rheumatology bv, M. Dougados Grant/research support: AbbVie, Celgene, Eli Lilly, Novartis, Pfizer, Roche, and Sanofi-Aventis, J. Sieper Consultant for: Abbott, Eli-Lilly, Janssen, Merck, Novartis, Pfizer, and UCB, Speakers bureau: Abbott, Eli-Lilly, Janssen, Merck, Novartis, Pfizer, and UCB, J. Braun Grant/research support: Abbott, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, and UCB, G. Citera Grant/research support: Pfizer, Consultant for: Bristol-Myers Squibb, Pfizer, and Abbott., C. Miceli-Richard Grant/research support: AbbVie, Bristol-Myers Squibb, Janssen, and Pfizer, Consultant for: AbbVie, Bristol-Myers Squibb, Janssen, and Pfizer, J. Wei Grant/research support: Abbott, AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Eli Lilly, GlaxoSmithKline, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB, Consultant for: Abbott, AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Eli Lilly, GlaxoSmithKline, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB, R. Pedersen Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, R. Bonin Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, I. Logeart Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, J. Wajdula Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, M. Rahman Employee of: Pfizer Inc at the time of the study, B. Vlahos Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, J. Bukowski Shareholder of: Pfizer Inc, Employee of: Pfizer Inc DOI 10.1136/annrheumdis-2014-eular.1138