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Annals of the Rheumatic Diseases | 2013

Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial

Michael E. Weinblatt; Clifton O. Bingham; A. Mendelsohn; L. Kim; Michael Mack; J. Lu; Daniel Baker; Rene Westhovens

Objectives Evaluate the efficacy of intravenous golimumab 2 mg/kg+methotrexate (MTX) in patients with active rheumatoid arthritis (RA) receiving MTX. Methods Patients (n=592) with active disease (≥6/66 swollen, ≥6/68 tender joints, C-reactive protein ≥1.0 mg/dl, rheumatoid factor positive and/or anticyclic citrullinated protein antibody positive at screening) despite MTX (15–25 mg/week) participated in this double-blind, placebo-controlled, phase 3 study. Patients were randomised (2:1) to receive intravenous golimumab 2 mg/kg, or placebo infusions at weeks 0 and 4 and every (q) 8 weeks; patients continued MTX. Placebo patients with <10% improvement in combined swollen/tender joint counts at week 16 could early escape to intravenous golimumab 2 mg/kg. The primary endpoint was week 14 American College of Rheumatology 20% (ACR20) response. Analyses employed non-responder imputation and last-observation-carried-forward. Results At week 14, significantly (p<0.001) larger proportions of golimumab+MTX than placebo+MTX patients achieved ACR20 response (59% vs 25%, respectively), a disease activity score of good/moderate (EULAR) response (81% vs 40%), and greater median improvement in health assessment questionnaire scores (0.500 vs 0.125). Improvements versus placebo+MTX were observed by week 2. Similar proportions of patients receiving golimumab+MTX and placebo+MTX, respectively, reported adverse events through week 16 (47% and 44%) and week 24 (53% and 49%). Serious adverse events were reported by more golimumab+MTX (4.1%) than placebo+MTX (2%) patients at week 24. Conclusion The addition of intravenous golimumab rapidly and significantly improved signs and symptoms in patients with active RA despite ongoing MTX, in some patients by week 2.


Annals of the Rheumatic Diseases | 2014

Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study)

Arthur Kavanaugh; Iain B. McInnes; Philip J. Mease; Gerald G. Krueger; Dafna D. Gladman; Désirée van der Heijde; Yiying Zhou; J. Lu; Jocelyn H. Leu; Neil Goldstein; Anna Beutler

Objectives Assess golimumabs long-term efficacy/safety in psoriatic arthritis (PsA). Methods Adults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks (q4wks) through wk20. All patients received golimumab 50 mg or 100 mg q4wks from wk24 forward. Methotrexate was allowed and taken by approximately half the patients. Findings through 5 years are reported herein. Efficacy assessments included ≥20% improvement in American College of Rheumatology (ACR20) response, C-reactive-protein-based, 28-joint-count Disease Activity Score (DAS28-CRP) response, ≥75% improvement in Psoriasis Area and Severity Index (PASI75) scores, and PsA-modified Sharp/van der Heijde scores (SHSs). Results 126/405 (31%) randomised patients discontinued treatment through wk252. Golimumab was effective in maintaining clinical improvement through year-5 (ACR20: 62.8–69.9%, DAS28-CRP: 75.2-84.9% for randomised patients; PASI75: 60.8–72.2% among randomised patients with ≥3% body surface area involvement) and inhibiting radiographic progression (mean changes in PsA-modified SHS: 0.1–0.3) among patients with radiographic data. While concomitant methotrexate did not affect ACR20/PASI75, it appeared to reduce radiographic progression. No new safety signals were identified. Antibodies-to-golimumab occurred in 1.8%/10.0% of patients with/without methotrexate). Conclusions Long-term golimumab safety/efficacy in PsA was demonstrated through 5 years. Trial registration number NCT00265096.


Annals of the Rheumatic Diseases | 2014

Early MRI measures independently predict 1-year and 2-year radiographic progression in rheumatoid arthritis: secondary analysis from a large clinical trial

Joshua F. Baker; Mikkel Østergaard; Paul Emery; Elizabeth C. Hsia; J. Lu; Daniel Baker; Philip G. Conaghan

Objective To determine if early MRI measures predict X-ray progression at 1 and 2 years in a large RA trial cohort. Design This study included 256 methotrexate (MTX)-naïve RA patients from a randomised placebo-controlled trial of golimumab (GO-BEFORE). MRIs of wrist and 2nd–5th metacarpophalangeal joints at 0, 12, 24, 52 and 104 weeks were obtained and scored using the RAMRIS system. Multivariable logistic regression examined if baseline and early change (weeks 12/24) in RAMRIS scores independently predicted progression of the van der Heijde-Sharp (vdHS) score and MRI erosion score at 1 and 2 years of follow-up. Results High baseline score and poor improvement over the first 24 weeks in synovitis (p=0.003 and p=0.003, respectively) and in bone oedema (p=0.02 and p=0.001, respectively) were independent predictors of X-ray progression at 1 year. Associations were significant or tended towards an association at 2 years. An increase in RAMRIS bone erosion >0.5 at weeks 12 and 24 also predicted X-ray progression (p<0.003). Poor 12-week improvement in bone oedema was associated with X-ray and MRI progression at 1 year (p<0.05). Regression models that incorporated baseline and 12-week and 24-week changes in MRI measures of synovitis (AUC=0.71) and bone oedema (AUC=0.70) improved the prediction of X-ray progression at 1 year above clinical disease activity alone (AUC=0.66, p<0.04). Conclusions Baseline and early changes in MRI measures independently predicted X-ray and MRI progression at later time-points. The predictive validity established here supports potential use in shorter-duration studies to determine efficacy of RA therapies in preventing structural damage.


Annals of the Rheumatic Diseases | 2014

Radiographic benefit and maintenance of clinical benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: results up to 1 year of the phase 3, randomised, multicentre, double blind, placebo controlled GO-FURTHER trial

Michael E. Weinblatt; Rene Westhovens; A. Mendelsohn; L. Kim; Kim Hung Lo; S. Sheng; L. Noonan; J. Lu; Zhenhua Xu; Jocelyn H. Leu; Daniel Baker; Clifton O. Bingham

Objective Report on radiographic effects and maintenance of clinical benefit with intravenous golimumab 2 mg/kg+methotrexate (MTX) for up to week (wk) 52 in active rheumatoid arthritis (RA). Methods Patients (n=592) with active RA (≥6/66 swollen, ≥6/68 tender joints, C reactive protein (CRP) ≥1.0 mg/dL and positive for rheumatoid factor and/or anticyclic citrullinated protein antibody at screening) despite MTX ≥3 months (stable dose of 15–25 mg/week for ≥4 weeks) participated in this multicentre, international, randomised, double blind, placebo controlled, phase 3 study. Patients were randomised (2:1) to receive intravenous golimumab 2 mg/kg or placebo infusions at weeks 0 and 4 and then every 8 weeks; patients continued their stable MTX regimen. Placebo patients started golimumab 2 mg/kg at wk16 (early escape; <10% improvement in tender and swollen joints) or wk24 (crossover by design). Week 24 and wk52 radiographic (van der Heijde-Sharp (vdH-S) scores), clinical efficacy and safety data up to 1 year are reported here. Results Significant and rapid clinical improvement was observed up to wk24 of intravenous golimumab therapy. Golimumab+MTX treated patients demonstrated less radiographic progression than placebo treated patients at wk24 (vdH-S score mean change 0.03 vs 1.09; p<0.001) and wk52 (0.13 vs 1.22; p=0.001). Among patients with ≥20% improvement in the American College of Rheumatology response criteria or who achieved a ‘good’ or ‘moderate’ response according to the 28 joint Disease Activity Score employing CRP at wk24, approximately 80% maintained this response up until wk52. Through an average of 43.5 weeks of follow-up, 64.6% of patients receiving golimumab+MTX reported adverse events, most commonly non-serious infections. Conclusions In patients with active RA despite MTX, intravenous golimumab+MTX yielded significant inhibition of structural damage at wk24 and wk52, and sustained clinical improvement in signs and symptoms with no new safety signals up to 1 year. ClinicalTrials.gov NCT00973479, EudraCT 2008–006 064–11.


Annals of the Rheumatic Diseases | 2014

FRI0266 Health-Related Quality of Life of Patients with Rheumatoid Arthritis Achieving DAS28 Remission, Improvement in Physical Function and NO Radiographic Progression after Treatment with Intravenous Golimumab

Rene Westhovens; Michael E. Weinblatt; Chenglong Han; L. Kim; Michael Mack; J. Lu; Daniel Baker; A. Mendelsohn; Clifton O. Bingham

Objectives To evaluate “comprehensive remission” in patients with rheumatoid arthritis (RA) treated with intravenously administered golimumab (GLM) and the association with normalized health related quality of life (HRQOL). Methods GO-FURTHER was a multicenter, randomized, placebo-controlled study. Adult patients with active RA despite MTX therapy (≥6 tender and swollen joints, CRP ≥1.0 mg/dL, and RF and/or anti-CCP positive) were randomized to placebo (PBO) + MTX or GLM (2mg/kg) plus MTX at week 0, 2, and every 8 week thereafter (GLM group). Patients in PBO group with <10% improvement in tender and swollen joint count from baseline at week 16 entered early escape (EE) and received a 2 mg/kg GLM infusion at weeks 16 and 20 and every 8 weeks subsequent. HRQOL was assessed using Short-Form of 36 items questionnaire (SF-36) and FACIT-fatigue. Employability was defined as being employed or to be able to work if job is available. Radiographic progression was measured using Total Sharp score (TSS). “Comprehensive remission” was defined as achieving low disease activity score (DAS28 using CRP <2.6), normalized physical function (HAQ-DI≤0.5) and no radiographic progression (change in TSS ≤ Smallest detectable change). Remission was also assessed using criteria of Simplified Disease Activity Index (SDAI, ≤3.3). Results Compared to PBO+MTX group at week 24, greater proportion of patients in GLM IV group achieved DAS28<2.6 (17.7% vs. 5.1%, p<0.001), HAQ-DI score≤0.5 (29.4% vs. 16.2%, p<0.001) or no radiographic progression (91.4% vs. 80.7%, p<0.001). “Comprehensive remission” rate was 10.1% in GLM group vs. 2.5% in PBO+MTX group (p=0.001). Additionally, SDAI remission at week 24 was 7.6% in GLM group vs. 2.0% in PBO+MTX group (P<0.01).”Comprehensive remission” was sustained in the GLM group over time at week 52 (12.4%) or week 100-112 (15.4%). Compared to patients who achieved DAS28 remission or SDAI remission, patients who achieved “comprehensive remission” at week 24 achieved numerically greater improvement in normalized HRQOL in SF-36 PCS and MCS and in FACIT-fatigue, and were more likely regain employability at Week 24, 52 or week 112. Conclusions By taking into consideration of outcomes reported by clinician and patient, and radiographic progression, “comprehensive remission” might be a more desirable treatment goal for patients with RA. Disclosure of Interest R. Westhovens Grant/research support: Janssen R & D, LLC, M. Weinblatt Grant/research support: Janssen R & D, LLC, C. Han Employee of: Janssen Pharmaceutical Services, LLC, L. Kim Employee of: Janssen R & D, LLC, M. Mack Employee of: Janssen R & D, LLC, J. Lu Employee of: Janssen R & D, LLC, D. Baker Employee of: Janssen R & D, LLC, A. Mendelsohn Employee of: Janssen R & D, LLC, C. Bingham III Grant/research support: Janssen R & D, LLC, Consultant for: Janssen R & D, LLC DOI 10.1136/annrheumdis-2014-eular.3819


Annals of the Rheumatic Diseases | 2013

SAT0486 Early MRI Measures Independently Predict 1- and 2- Year X-Ray Progression: Results from a Large Clinical Trial

Joshua F. Baker; M Ostergaard; Paul Emery; Elizabeth C. Hsia; J. Lu; Daniel Baker; P. Conaghan

Objectives Early predictors of progression in structural joint damage in RA are lacking. We evaluated if early MRI measures of inflammation & erosion at baseline (BL), 12 & 24wks could predict subsequent progression in structural damage as measured by standard x-ray at 1 & 2 yrs of follow-up among 256 pts from GO-BEFORE, a large randomized trial of golimumab+MTX vs MTX alone in RA pts who were MTX-naïve. Methods Methods & results of the original trial have been published1. MRIs (contrast-enhanced; 1.5T) of the wrist & the 2nd-5th metacarpophalangeal joints of the dominant hand at BL & wks12, 24, 52, & 104 were obtained. MRIs were scored by 2 independent, blinded readers using the RA MRI Scoring (RAMRIS) system. X-rays (hands, wrists, forefeet at BL, wk 52, & 104) were scored by 2 other, blinded readers using the van der Heijde-Sharp (vdHS) system. X-ray progression was defined as a change in vdHS score > 0.5 as it was in the original trial. MRI synovitis & bone edema scores were evaluated as continuous variables (per unit difference or change). Change in RAMRIS bone erosion scores was highly skewed, & was therefore dichotomized at >0.5. Multivariable logistic regression was used to determine if BL & early measures of change in component RAMRIS scores predicted x-ray progression independent of clinical disease activity [DAS28(CRP)], change in DAS28(CRP), age, sex, BL vdHS score, & treatment group. Results Higher BL synovitis scores & less improvement in synovitis over the first 24 wks of follow-up were both significantly & independently associated with a greater risk of x-ray progression at 1- & 2 yrs (Table). Higher BL bone edema & less improvement in bone edema were independently associated with a greater risk of x-ray progression at 1yr, & tended to be associated with progression at 2yrs. An increase in RAMRIS bone erosion score >0.5 at wk 24 significantly predicted x-ray progression at 1- & 2 yrs. BL & wk12 changes in MRI scores all significantly predicted x-ray progression at wk52 (all p<0.05), & tended to be associated with x-ray progression at wk 104 (p= 0.004-0.2). Conclusions Early MRI measures at 12 & 24 wks independently predict x-ray changes at 1 & 2 yrs of follow-up. These data support the use of MRI in clinical trials for early identification of pts with (OR who will develop) structural joint damage progression during follow-up. This has implications for clinical trial design. References Østergaard M, Emery P, Conaghan PG, et al. Arthritis Rheum2011; 63(12): 3712-3722. Disclosure of Interest J. Baker Grant/research support from: Janssen R&D, LLC, M. Østergaard Grant/research support from: Janssen R&D, LLC, P. Emery Grant/research support from: Janssen R&D, LLC, E. Hsia Employee of: Janssen R&D, LLC, J. D. Lu Employee of: Janssen R&D, LLC, D. Baker Employee of: Janssen R&D, LLC, P. G. Conaghan Grant/research support from: Janssen R&D, LLC


Annals of the Rheumatic Diseases | 2013

FRI0169 Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with results observed by 2 weeks: Results of the phase 3, multicenter, double-blind, placebo-controlled trial

Michael E. Weinblatt; Clifton O. Bingham; A. Mendelsohn; L. Kim; Michael Mack; J. Lu; Daniel Baker; Rene Westhovens

Objectives To evaluate the efficacy of IV GLM 2mg/kg+MTX in pts with active RA despite MTX. Methods Pts (n=592) with active RA (≥6/66 swollen joints, ≥6/68 tender joints, CRP≥1.0mg/dL, rheumatoid factor and/or anti-CCP antibodies positive at screening) despite ≥3mo of MTX (15-25mg/wk) participated in this multicenter, randomized, double-blind, placebo (PBO)-controlled phase 3 study. Pts were randomized to IV GLM 2mg/kg or PBO at wks0&4 and q8wks; all pts continued their stable MTX. Pts randomized to PBO with <10% improvement in combined swollen & tender joint counts at wk16 could early escape to IV GLM 2mg/kg (wks16&20, q8wks). Primary study endpoint was ACR20 at wk14. Responses are reported using a non-responder imputation, with LOCF for continuous variables. Results Baseline demographic and disease characteristics were comparable between grps (80.4% Caucasian, 81.6% female, median age 52yrs, median weight 69.6kg, median swollen joint/tender joint counts 12.0/23.0, median CRP 1.9mg/dL, median DAS28-CRP 5.9, median HAQ 1.625). Baseline mean CDAI scores were 38.5 and 38.4 and baseline mean SDAI scores were 41.3 and 40.6, for GLM+MTX and PBO+MTX grps, resp. 96% of pts (570/592) completed the 24wk study period; 4% (22/592) of pts discontinued, mostly due to AE (2.3%,GLM+MTX and 1.0, PBO+MTX). 34.5% of pts in the PBO+MTX grp entered early escape and initiated GLM at wk16 and were considered non-responders in subsequent analyses. At wk14, significantly (p<0.001) larger proportions of pts receiving GLM+MTX vs PBO+MTX achieved ACR20 (59% vs 25%, resp), DAS28-CRP good/moderate response (81% vs 40%, resp), ACR50 and a greater median improvement in HAQ score (0.500 vs 0.125, resp), all of which were also significantly improved vs PBO at wk2 (wk2 assessments not corrected for multiplicity). In post-hoc analysis, significant improvements were seen in CDAI and SDAI measurements at wk14 (p<0.001). At wk14, consistent treatment effects for ACR20 were observed across subgroup analyses. Similar proportions of pts receiving GLM+MTX and PBO+MTX reported AE through wk16 (47% and 44%) and wk24 (53% and 49%). Through wk24, serious AEs, most commonly serious infections, were reported by more GLM+MTX (4% and 1%, resp) than PBO+MTX (2% and 0%, resp) pts. No cases of TB or serious opportunistic infections were reported. 1 pt in PBO+MTX group died (presumed stroke). Through wk24,proportion of infusions with infusion reactions and pts with infusion reactions were 1.1% vs. 0.2% and 3.5% vs 0.5% in the GLM+MTX and PBO+MTX grps, resp. There were no serious infusion reactions. Conclusions IV GLM+MTX significantly improved RA signs and symptoms in pts with active RA despite ongoing MTX,in some cases within 2 wks. Disclosure of Interest M. Weinblatt Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, C. Bingham III Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, A. Mendelsohn Employee of: Janssen Research & Development, LLC, L. Kim Employee of: Janssen Research & Development, LLC, M. Mack Employee of: Janssen Research & Development, LLC, J. Lu Employee of: Janssen Research & Development, LLC, D. Baker Employee of: Janssen Research & Development, LLC, R. Westhovens Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study


Annals of the Rheumatic Diseases | 2013

AB0491 Fatigue is an independent variable predicting physical function and DAS-28 remission for patients with rheumatoid arthritis treated with intravenously administered golimumab: results from phase 3, placebo controlled clinical trial

Rene Westhovens; Michael E. Weinblatt; C. Han; T. Gathany; L. Kim; Michael Mack; J. Lu; Daniel Baker; A. Mendelsohn; Clifton O. Bingham


Annals of the Rheumatic Diseases | 2013

THU0218 Intravenous Golimumab Inhibits Radiographic Progression and Maintains Clinical Efficacy and Safety in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy: 1-Year Results of a Phase 3 Trial

Michael E. Weinblatt; Clifton O. Bingham; A. Mendelsohn; L. Noonan; S. Sheng; L. Kim; K. Hung; J. Lu; Daniel Baker; Rene Westhovens


Annals of the Rheumatic Diseases | 2013

SAT0270 5 Year Safety, Efficacy, and Radiographic Data in Patients with Active Psoriatic Arthritis Treated with Golimumab: Long-Term Extension Results of the Randomized, Placebo-Controlled Study Go-Reveal

Arthur Kavanaugh; D. van der Heijde; I McInnes; P. Mease; Gerald G. Krueger; Dafna D. Gladman; Yiying Zhou; J. Lu; Zhenhua Xu; L. Noonan; Anna Beutler

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Michael E. Weinblatt

Brigham and Women's Hospital

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L. Kim

Janssen Pharmaceutica

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Rene Westhovens

Katholieke Universiteit Leuven

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L. Noonan

Janssen Pharmaceutica

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