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
Authors: M. Weinblatt, C. O. Bingham, A. Mendelsohn, L. Noonan, S. Sheng, L. Kim, K. Hung, J. Lu, D. Baker, R. Westhovens
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Objectives</h3> Evaluate long-term efficacy of IV GLM 2mg/kg+MTX in active RAdespite MTX thru wk52. <h3>Methods</h3> Pts(n=592)with active RA(≥6/66 SJ,≥6/68TJ, CRP≥1.0mg/dL, RF&amp;/or anti-CCP+at screen)despite ≥3mo of MTX(15-25mg/wk)participated. Pts rand to IV GLM2mg/kgorPBO at wks0&amp;4 &amp;q8wks;all pts cont’d stable MTX. Pts rand to PBO with&lt;10% improve’t in SJ+TJ cts atwk16 could EE to IV GLM2mg/kg(wks16&amp;20, q8wks). All PBO pts rec’d IV GLM2mg/kg starting atwk24. Primary endpt was wk14 ACR20. Radiographs of hands&amp;feet at baseline(BL), wk24(wk16 for EE)&amp; wk52 were scored by 2independent readers&amp;adjudicator(asneeded)using modified vdHS score. <h3>Results</h3> 93% of pts(553/592)cont’d thru wk52;39 pts d/c, mostly due to AEs(18 pts). At wk14, sig (p&lt;0.001)larger propor of GLM+MTXvsPBO+MTX pts achieved ACR20,50,70, DAS28-CRP good/mod responses,&amp;greater median improv’t in HAQ(0.50vs0.13). Among pts who achieved ACR20,50,70,&amp; DAS28 good/mod by wk24, 82%,72%,61%,&amp;88%, resp, maintained response thru wk52. At wk52, ACR20,50,70 for GLM&amp;PBO grps were: 65.8%,38.7%,18.2%,&amp; 61.4%,31.5%,14.7%. DAS28-CRP mod/good were 81.3%&amp;75.6% for GLMvsPBO grp. Median improv’t from BL HAQ were:0.51±0.65 &amp; 0.42±0.59 for GLMvsPBO grp; improve’ts in HAQ≥0.25 fromBL:64.1%&amp;62.4% of pts, resp. GLM+MTX-tx pts showed sig less radiographic progression(RP)(total vdHS+subscores)vs PBO+MTX at wk24. Pts rand to PBO+MTX who began GLM at wk16/24 showed marked slowing of RP same rate as pts rand to GLM, from wk24towk52. Thru wk52, all GLM-tx pts were followed an avg of 44wks. AEs&amp; SAEs occurred in 65%&amp;9%, resp, of GLM-tx pts(vs 43%&amp;4% at wk24).1 case of TB &amp;no serious opportunistic infect’s were reported thru wk52.1 pt receiving GLM+MTX (0.16%)died. Thru wk52, propor of inf &amp;pts with inf reactions were 0.7% &amp;3.6%, resp,(vs 1.1%&amp;3.5% at wk24). <h3>Conclusions</h3> GLM+MTX sig inhibited RP(for total vdHS&amp;subscores)at wk24&amp;52. Among PBO-tx pts who began GLM at wk16/wk24, marked slowing of RP, to the rate in pts rand to GLM, was observed from wk24towk52. IV GLM+MTX sig improv’d&amp;maintained RA signs&amp;sx in active RA despite ongoing MTX&amp;cont’d to show acceptable safety profile thru wk52. <h3>Disclosure of Interest</h3> M. Weinblatt Grant/research support from: Janssen R&amp;D, LLC, C. O. Bingham III Grant/research support from: Janssen R&amp;D, LLC, A. Mendelsohn Employee of: Janssen R&amp;D, LLC, L. Noonan Employee of: Janssen R&amp;D, LLC, S. Sheng Employee of: Janssen R&amp;D, LLC, L. Kim Employee of: Janssen R&amp;D, LLC, K. Hung Employee of: Janssen R&amp;D, LLC, J. Lu Employee of: Janssen R&amp;D, LLC, D. Baker Employee of: Janssen R&amp;D, LLC, R. Westhovens Grant/research support from: Janssen R&amp;D, LLC