SAT0389 INHIBITION OF RADIOGRAPHIC PROGRESSION WAS ACHIEVED WITH INTRAVENOUS GOLIMUMAB IN ACTIVE PSA PATIENTS REGARDLESS OF CHANGES IN COMPOSITE INDICES OF DISEASE ACTIVITY IN A PHASE III TRIAL
Authors: Philip J. Mease, M Elaine Husni, Shelly Kafka, Soumya D. Chakravarty, Diane D. Harrison, Kim Hung Lo, Stephen Xu, Elizabeth C. Hsia, Arthur Kavanaugh
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> GO-VIBRANT is a Phase 3 trial of intravenous (IV) golimumab (GLM), an anti-tumor necrosis factor alpha (TNFα) monoclonal antibody, in adult patients (pts) with active psoriatic arthritis (PsA). <h3>Objectives</h3> To assess if changes in Disease Activity in PsA (DAPSA), PsA Activity Score (PASDAS), Minimal Disease Activity (MDA), Very Low Disease Activity (VLDA), and Clinical Disease Activity Index (CDAI) measures correlate with X-ray progression. <h3>Methods</h3> In this multicenter, randomized, double-blind, placebo (PBO)-controlled trial, 480 bionaïve PsA pts with active disease (≥5 swollen &amp; ≥5 tender joints, C-reactive protein ≥0.6mg/dL, active plaque psoriasis or documented history despite treatment w/csDMARDs &amp;/or NSAIDs) received IV GLM 2mg/kg (N=241) at Wks0/4 then q8wks or PBO (N=239) at Wks0/4/12/20 with crossover to GLM at Wk24. In a post-hoc analysis, association of disease activity measures DAPSA, PASDAS, MDA, VLDA, &amp; CDAI with X-ray progression was examined. Total modified van der Heijde-Sharp (vdH-S) score assessed X-ray progression at Wks 0/24/52. Last observation carried forward imputation was used for partially missing data &amp; non-responder imputation for missing data. Nominal p-values are reported without multiplicity adjustment. <h3>Results</h3> Mean changes from baseline in vdH-S scores were lower with GLM than PBO at Wk24 (-0.36 vs 1.95, respectively, p&lt;0.001) and at Wk52 after crossover from PBO to GLM arm (-0.49 vs 0.76). Changes in all disease activity measures appeared to correlate with X-ray progression (Table). GLM-treated pts had less X-ray progression regardless of disease activity measure. GLM treated pts in remission or with low disease activity tended to have less X-ray progression at Wk52 vs pts with moderate or high disease activity (mean change in vdH-S: DAPSA remission or low disease activity -0.88, moderate activity -0.48, high disease activity 0.41). Similar patterns were seen with PASDAS and CDAI (Table). Irrespective of level of disease activity, GLM-treated pts from Wk 0-52 tended to have less X-ray progression vs PBO-treated pts who switched to GLM at Wk24 (mean change in vdH-S 0-52 wk GLM vs PBO→GLM: DAPSA remission or low disease activity -0.88 vs 1.49, moderate activity -0.48 vs 1.38, high disease activity 0.41 vs 1.27). Interestingly, pts treated with GLM who did not achieve MDA or VLDA by Wk52 also tended to have less X-ray progression vs PBO pts (mean change no MDA GLM 0.03 vs PBO 1.50; p=0.0011 and mean change no VLDA GLM -0.30 vs PBO 1.45; p&lt;0.0001). <h3>Conclusion</h3> In this analysis, all disease activity measures generally correlated with X-ray progression from baseline to Wk24 and to Wk52. Higher disease activity was associated with increased X-ray progression. GLM–treated pts not achieving MDA &amp; VLDA at Wk52 tended to have less X-ray progression vs PBO→GLM pts. GLM's ability to inhibit X-ray progression, despite pts not being in clinical remission or low disease activity, illustrates an example of "disconnect" between clinical outcomes &amp; X-ray progression seen in other studies. <h3>Disclosure of Interests</h3> Philip J Mease Grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Consultant for: AbbVie, Amgen, BMS, Galapagos, Gilead Sciences, Inc., Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer and UCB, M Elaine Husni Grant/research support from: Janssen, Shelly Kafka Shareholder of: J&amp;J, Employee of: J&amp;J, Soumya D Chakravarty Shareholder of: Johnson &amp; Johnson, Employee of: Johnson &amp; Johnson, Diane D Harrison Employee of: Janssen Research &amp; Development, LLC, Kim Hung Lo Employee of: Janssen Research &amp; Development, LLC, Stephen Xu Employee of: Employee of Janssen Research &amp; Development, LLC, Elizabeth C Hsia Employee of: Employee of Janssen Research &amp; Development, LLC, Arthur Kavanaugh Grant/research support from: UCB Pharma