PT  - JOURNAL ARTICLE
AU  - Arthur Kavanaugh
AU  - M. Elaine Husni
AU  - Diane D. Harrison
AU  - Lilianne Kim
AU  - Kim Hung Lo
AU  - Lenore Noonan
AU  - Elizabeth C. Hsia
TI  - Radiographic Progression Inhibition with Intravenous Golimumab in Psoriatic Arthritis: Week 24 Results of a Phase III, Randomized, Double-blind, Placebo-controlled Trial
AID  - 10.3899/jrheum.180681
DP  - 2019 Jun 01
TA  - The Journal of Rheumatology
PG  - 595--602
VI  - 46
IP  - 6
4099  - http://www.jrheum.org/content/46/6/595.short
4100  - http://www.jrheum.org/content/46/6/595.full
SO  - J Rheumatol2019 Jun 01; 46
AB  - Objective. Evaluate effects of intravenous (IV) golimumab (GOL) on radiographic progression in psoriatic arthritis (PsA).Methods. This phase III, randomized, double-blind, placebo-controlled trial (GO-VIBRANT) randomized patients with active PsA to receive IV placebo (n = 239) or IV GOL 2 mg/kg (n = 241) at weeks 0, 4, 12, and 20. Radiographic progression (controlled secondary endpoint) was evaluated as change from baseline at Week 24 in PsA-modified total Sharp/van der Heijde scores (SvdH). The proportions of patients with a change from baseline at Week 24 in the total PsA-modified SvdH exceeding the smallest detectable change (SDC) or > 0 or 0.5 also were determined.Results. Overall, 474 patients (237/arm) contributed radiographic data. Results obtained from the 2 blinded, independent radiographic readers demonstrated good agreement (total score intraclass correlation coefficients: baseline = 0.93, Week 24 = 0.92, Week 24 change score = 0.73). GOL demonstrated significant inhibition of radiographic progression relative to placebo from baseline to Week 24 (mean changes in PsA-modified total SvdH: −0.36 vs 1.95; treatment difference: −2.32; p < 0.001). At Week 24, smaller proportions of GOL- versus placebo-treated patients demonstrated an increase in the total PsA-modified SvdH score exceeding the SDC (8.0% vs 27.0%, respectively; difference: −19.0%; p < 0.001), > 0 (28.3% vs 57.0%, respectively; difference: −28.7%; p < 0.001), or > 0.5 (18.6% vs 41.8%, respectively; difference: −23.2%; p < 0.001). Results were consistent for erosion and joint space narrowing scores, in hands and feet, and in patients with/without baseline concomitant methotrexate use. Prevention of radiographic progression by GOL was independent of clinical response.Conclusion. IV GOL is significantly better than placebo in inhibiting radiographic progression of structural damage in active PsA. [Clinical trial registration number (www.ClinicalTrials.gov): NCT02181673]