Improvements for Patients with Active Psoriatic Arthritis in GO-VIBRANT Study
Golimumab is safe and effective for treating PsA, according to the 24-week report of the GO-VIBRANT study.
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Our recently published 24-week report of the Go-VIBRANT trial demonstrates that intravenous golimumab is an effective and safe method of treating patients with active psoriatic arthritis (PsA). Extra-articular manifestation of PsA such as dactylitis or enthesitis, has also show benefit with golimumab. My colleagues and I, including first author Arthur Kavanaugh, MD, released the results in Arthritis and Rheumatology.
Given the changing landscape of psoriatic disease treatment, a more tailored approach taking into account disease characteristics, prior treatments and patient preferences, is now possible. Rheumatologists can take advantage of oral, subcutaneous and intravenous treatment options for PsA. Less severe disease forms can be treated with non-steroidal anti-inflammatory (NSAID) agents, whereas more severe or resistant forms are treated with disease modifying anti-rheumatic drugs (DMARDs) like methotrexate or anti-TNFɑ biologic agents.
Current advances in the field are focused on determining the efficacy of novel biologic drugs that can specifically target the inflammatory cascade that leads to irreversible damage, disability and poor quality of life in PsA patients.
The GO-VIBRANT trial is a randomized, double-blinded, placebo controlled study intended to evaluate the efficacy at 24 weeks of golimumab, a fully human monoclonal antibody against tumor necrosis factor alpha (TNF-ɑ). The study investigated the drug’s effect on patients who had active disease despite conventional therapy with DMARDs or NSAIDs. The primary outcome of the study was the proportion of patients achieving American College of Rheumatology 20 percent improvement criteria (ACR20), which is improved in patients receiving golimumab compared to placebo.
In addition to disease response, we evaluated health-related quality of life using Short Form 36 (SF-36), and disability using the Health Assessment Questionnaire disability index (HAQ DI). Both of these parameters were improved at 24 weeks in the treatment groups, demonstrating that golimumab limits the devastating effects of PsA on patients’ lives.
Though primary outcomes of improvement in rheumatologic diseases are based on patient-reported outcomes, exam findings and laboratory results, golimumab was also found to have radiologic evidence of disease control. In our study, radiographs were completed at the time of therapy initiation as well as at week 24, and disease burden was quantified using the Sharp/van der Heijde score (SHS). Importantly, radiologists were blinded to the treatment group. Patients treated with golimumab had significant improvements in erosion and joint space narrowing, which provides further evidence of the efficacy of this intravenous biologic drug.
In the previously published GO-REVEAL trial, patients with PsA symptoms achieved significantly greater improvement when treated with subcutaneous golimumab compared to placebo. Despite the benefit of self-injection offered by subcutaneous preparations, many patients either are not interested in self-injection or prefer having drugs delivered in a healthcare setting via an IV. The Go-VIBRANT study reaffirms the efficacy of golimumab, now in intravenous preparation.
Patient preferences should help drive treatment algorithms, and the GO-VIBRANT study gives rheumatologists an intravenous biologic option for treating psoriatic arthritis. Golimumab improves disease activity, patient-reported outcomes and radiographic measurements as demonstrated in this 24-week analysis. We look forward to reporting the one-year outcomes, which promise to provide further evidence for golimumab’s ability to improve the lives of patients with PsA.
Dr. Husni is Director of the Arthritis and Musculoskeletal Treatment Center and Endowed Chair of Translational Functional Medicine Research at Cleveland Clinic.