Safety and Efficacy of Intravenous Golimumab in Patients With Active Psoriatic Arthritis

Abstract

ObjectiveTo evaluate the safety and efficacy of intravenous (IV) golimumab treatment in psoriatic arthritis (PsA).MethodsIn this phase III, randomized, double‐blind, placebo‐controlled trial, patients were randomly assigned to receive IV placebo (n = 239) or golimumab at 2 mg/kg (n = 241) at weeks 0, 4, 12, and 20. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 14. Controlled secondary end points included change from baseline in Health Assessment Questionnaire disability index (HAQ DI) score at week 14, proportions of patients with ACR50 and ACR70 responses and ≥75% improvement on the Psoriasis Area and Severity Index (a PASI75 response) at week 14, and change from baseline at week 24 in the total modified Sharp/van der Heijde score (SHS) with modifications for patients with PsA.ResultsAt week 14, an ACR20 response was achieved by 75.1% of patients in the golimumab group compared with 21.8% of patients in the placebo group (P < 0.001). Greater proportions of golimumab‐treated patients had an ACR50 response (43.6% versus 6.3%), an ACR70 response (24.5% versus 2.1%), and a PASI75 response (59.2% versus 13.6%) at week 14 (P < 0.001 for all). Patients in the golimumab group had greater mean changes at week 14 in HAQ DI score (–0.60 versus –0.12; P < 0.001). At week 24, the mean change in total PsA‐modified SHS was –0.4 in the golimumab group and 2.0 in the placebo group (P < 0.001). Through week 24, 40.6% of patients in the placebo group and 46.3% of patients in the golimumab group had ≥1 adverse event (AE); infections were the most common type.ConclusionPatients receiving IV golimumab at 2 mg/kg had significantly greater improvements in the signs and symptoms of PsA and less radiographic progression through week 24. AEs were consistent with those seen with other anti–tumor necrosis factor agents.

Inhibition of radiographic progression across levels of composite index-defined disease activity in patients with active psoriatic arthritis treated with intravenous golimumab: results from a phase-3, double-blind, placebo-controlled trial

“…The fully human anti-TNFα monoclonal antibody golimumab has demonstrated long-term clinical efficacy and inhibition of structural damage in patients with moderate-to-severe PsA [7][8][9][10]. Given the importance of assessing the diverse manifestations in patients with PsA [5], we conducted post hoc analyses to assess changes in radiographic progression in patients with varying levels of composite index-defined disease activity following treatment with IV golimumab or placebo in the large phase 3 GO-VIBRANT PsA trial [9,10]. Composite endpoints were chosen for these analyses because they allow the assessment of multiple clinical manifestations in a single instrument [21].…”

“…Details of the GO-VIBRANT study design and participant eligibility criteria have been reported [9,10]. Briefly, eligible patients were bio-naïve, had PsA based on the ClASsification of Psoriatic ARthritis (CASPAR) criteria [11] for ≥ 6 months, and demonstrated active disease (swollen joint count [SJC] ≥ 5 and tender joint count [TJC] ≥ 5 at screening and baseline and screening Creactive protein [CRP] ≥ 0.6 mg/dL), despite therapy with disease-modifying antirheumatic drugs (≥ 3 months) and/or nonsteroidal anti-inflammatory drugs (≥ 4 weeks) or an intolerance to these therapies.…”

“…Patient disposition through week 24 [9] and week 52 [10] of GO-VIBRANT has been reported. Briefly, data were collected from September 2014 to March 2017 at 90 sites in 11 European and North American countries.…”

“…Golimumab (Janssen Biotech Inc., Horsham, PA, USA) is a fully human anti-tumor necrosis factor alpha (TNFα) monoclonal antibody shown to be effective in patients with RA, ankylosing spondylitis, and PsA [6]. Specific to PsA, sustained clinical efficacy and inhibition of structural damage was observed in patients with moderate-to-severe PsA in both the GO-REVEAL trial of subcutaneous (SC) golimumab [7,8] and the GO-VIBRANT trial of intravenous (IV) golimumab [9,10]. Given the importance of further evaluating the utility of composite indices to assess diverse manifestations in patients with PsA, we conducted post hoc analyses of data from GO-VIBRANT to assess changes in radiographic progression at 6 months and 1 year in patients with varying levels of composite indexdefined disease activity following treatment during both the controlled and uncontrolled study periods.…”

Efficacy and Safety of Intravenous Golimumab Through One Year in Patients With Active Psoriatic Arthritis

“…In the phase III GO‐VIBRANT study (A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Trial of Golimumab, an Anti‐TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Psoriatic Arthritis), adult patients with active PsA showed greater improvements in the signs and symptoms of PsA and less radiographic progression through week 24 when receiving intravenous (IV) golimumab compared with those who received placebo . Improvements in health‐related quality of life (HRQoL) were also greater for patients in the golimumab group . Adverse events (AEs) through week 24 were consistent with the known safety profile of IV golimumab.…”