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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
  1. M. Weinblatt1,
  2. C. O. Bingham III2,
  3. A. Mendelsohn3,
  4. L. Noonan3,
  5. S. Sheng3,
  6. L. Kim3,
  7. K. Hung3,
  8. J. Lu3,
  9. D. Baker3,
  10. R. Westhovens4
  1. 1Brigham&Women’s Hosp, Boston
  2. 2Johns Hopkins U, Baltimore
  3. 3Janssen R&D, LLC, Spring House, United States
  4. 4UZ Gasthuisberg, Leuven, Belgium


Objectives Evaluate long-term efficacy of IV GLM 2mg/kg+MTX in active RAdespite MTX thru wk52.

Methods Pts(n=592)with active RA(≥6/66 SJ,≥6/68TJ, CRP≥1.0mg/dL, RF&/or anti-CCP+at screen)despite ≥3mo of MTX(15-25mg/wk)participated. Pts rand to IV GLM2mg/kgorPBO at wks0&4 &q8wks;all pts cont’d stable MTX. Pts rand to PBO with<10% improve’t in SJ+TJ cts atwk16 could EE to IV GLM2mg/kg(wks16&20, q8wks). All PBO pts rec’d IV GLM2mg/kg starting atwk24. Primary endpt was wk14 ACR20. Radiographs of hands&feet at baseline(BL), wk24(wk16 for EE)& wk52 were scored by 2independent readers&adjudicator(asneeded)using modified vdHS score.

Results 93% of pts(553/592)cont’d thru wk52;39 pts d/c, mostly due to AEs(18 pts). At wk14, sig (p<0.001)larger propor of GLM+MTXvsPBO+MTX pts achieved ACR20,50,70, DAS28-CRP good/mod responses,&greater median improv’t in HAQ(0.50vs0.13). Among pts who achieved ACR20,50,70,& DAS28 good/mod by wk24, 82%,72%,61%,&88%, resp, maintained response thru wk52. At wk52, ACR20,50,70 for GLM&PBO grps were: 65.8%,38.7%,18.2%,& 61.4%,31.5%,14.7%. DAS28-CRP mod/good were 81.3%&75.6% for GLMvsPBO grp. Median improv’t from BL HAQ were:0.51±0.65 & 0.42±0.59 for GLMvsPBO grp; improve’ts in HAQ≥0.25 fromBL:64.1%&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& SAEs occurred in 65%&9%, resp, of GLM-tx pts(vs 43%&4% at wk24).1 case of TB &no serious opportunistic infect’s were reported thru wk52.1 pt receiving GLM+MTX (0.16%)died. Thru wk52, propor of inf &pts with inf reactions were 0.7% &3.6%, resp,(vs 1.1%&3.5% at wk24).

Conclusions GLM+MTX sig inhibited RP(for total vdHS&subscores)at wk24&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&maintained RA signs&sx in active RA despite ongoing MTX&cont’d to show acceptable safety profile thru wk52.

Disclosure of Interest M. Weinblatt Grant/research support from: Janssen R&D, LLC, C. O. Bingham III Grant/research support from: Janssen R&D, LLC, A. Mendelsohn Employee of: Janssen R&D, LLC, L. Noonan Employee of: Janssen R&D, LLC, S. Sheng Employee of: Janssen R&D, LLC, L. Kim Employee of: Janssen R&D, LLC, K. Hung Employee of: Janssen R&D, LLC, J. Lu Employee of: Janssen R&D, LLC, D. Baker Employee of: Janssen R&D, LLC, R. Westhovens Grant/research support from: Janssen R&D, LLC

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