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Highlights from

American College of Rheumatology

annual meeting 2018

Chicago, Illinois 19-24 October 2018

Did changes in composite indices of disease activity correlate with radiographic progression in the GO-VIBRANT trial of active PsA?

Take-home messages
  • GO-VIBRANT was a phase III trial of IV golimumab, a fully human anti-TNF-alpha monoclonal antibody, in adult patients with active PsA
  • In a post hoc analysis of GO-VIBRANT, disease activity as assessed by composite measures generally correlated with radiographic progression
  • The results, however, suggested that there may be a disconnect between clinical and radiographic outcomes
“Despite the fact that these patients have active disease with all of these composite measures, golimumab helps to inhibit radiographic progression, ie [there’s] a disconnect.”

Professor Philip J Mease Director of Rheumatology Research, Swedish Medical Center and Clinical Professor at the University of Washington, Seattle, US

Results from a post hoc analysis of the clinical trial GO-VIBRANT showed that, although disease activity as assessed by composite measures generally correlated with radiographic progression from baseline to week 24 and baseline to week 52, patients receiving golimumab who did not achieve minimal disease activity (MDA) or very low disease activity (VLDA) at week 52 (ie who showed active disease) still demonstrated inhibition of radiographic progression. In addition, patients who exhibited disease activity in psoriatic arthritis (DAPSA) or clinical disease activity index (CDAI) low disease activity also continued to show inhibition of radiographic progression.

“Despite the fact that these patients have active disease with all of these composite measures, golimumab helps to inhibit radiographic progression, ie [there’s] a disconnect,” noted Professor Philip J Mease, Director of Rheumatology Research, Swedish Medical Center and Clinical Professor at the University of Washington, Seattle, US, who presented the data at the 2018 American College of Rheumatology/ Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting.

Professor Mease continued, “this [disconnect] is consistent with other studies, for example an analysis that was done with adalimumab from the ADEPT study also demonstrated a disconnect between clinical and radiographic outcomes.”

GO-VIBRANT was a multicentre, double-blind, placebo-controlled trial with 480 bio-naive patients with psoriatic arthritis (PsA) randomised to either receive intravenous (IV) golimumab 2 mg/kg at weeks 0 and 4, then every 8 weeks through to week 52 or to receive placebo at weeks 0, 4, 12, and 20 with crossover to IV golimumab at weeks 24 and 28, then every 8 weeks thereafter through to week 52. All patients met classification criteria for psoriatic arthritis (CASPAR) criteria of active disease and had active or a documented history of plaque psoriasis.

In the placebo-controlled period at week 24, mean change from baseline in total modified van der Heijde-Sharp (vdH-S) score was -0.36 in the IV golimumab group versus 1.95 in the placebo group (p<0.001), indicating greater inhibition of radiographic progression with IV golimumab. This inhibition observed in the IV golimumab group at week 24 was sustained through week 52 (mean change from baseline in total modified vdH-S score at week 52: -0.49).

Patients receiving golimumab who had remitted or low disease activity tended to have less radiographic progression at week 52 versus patients with moderate or high disease activity (mean changes in vdH-S: CDAI remission -1.06, low -0.81, moderate 0.20, high 1.11).

Irrespective of level of disease activity, golimumab-treated patients from weeks 0-52 tended to have less radiographic progression versus placebo-treated patients who switched to golimumab at week 24 (mean changes in vdH-S from week 0-52 for golimumab vs placebo: remission -1.06 vs 1.52, low -0.81 vs 1.21, moderate 0.20 vs 1.32, high 1.11 vs 1.75).

Golimumab-treated patients with DAPSA scores ≤28 between week 0 and week 52 tended to have less radiographic progression (mean change ‑0.74) versus patient with scores >28 (mean change 0.41).

Patients treated with golimumab who, despite not achieving MDA or VLDA by week 52, also tended to have far less radiographic progression versus patients who received placebo (mean change MDA placebo 1.50 vs golimumab 0.03; p<0.0011 and mean change VLDA placebo 1.45 versus -0.30; p<0.0001).

Golimumab is a fully human anti-TNF-alpha monoclonal antibody and is approved for use in adult patients with active PsA.

Based on Mease P J, Kafka S et al. Inhibition of radiographic progression and correlation with changes in composite indices of disease activity in patients with active psoriatic arthritis treated with intravenous golimumab, as measured in a phase III trial (abstract 2889). Presented on Tuesday 23 October 2018.

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