Elaine Husni, MD, discusses the results of a trial she led examining quality of life changes in psoriatic arthritis patients receiving golimumab over a 1-year period.
Phase 3 data examining improvements in skin and nail psoriasis in psoriatic arthritis patients treated with intravenous golimumab from a 52-week trial is demonstrating the treatment’s ability to improve quality of life.
The analysis of GO-VIBRANT trial, included 394 adult biologic-naive patients with active disease despite treatment with conventional synthetic DMARDs or NSAIDs, was presented at the 2019 American College of Rheumatology annual meeting in Atlanta, GA. Patients included in the trial were randomized to receive golimumab at a dose of 2 mg per kg at weeks 0 and 4 and every 8 weeks after or placebo at weeks 0, 4, 12, and 20. Investigators noted patients who received placebo were switched to golimumab at week 24 of the trial.
Patients with 3% or greater body surface area psoriasis at baseline were assessed using Psoriasis Area and Severity Index(PASI) of 75/90/100% improvement scale, modified Nail Psoriasis Severity Index (mNAPSI) in patients with mNAPSI greater than 0 at baseline, and Dermatology Life Quality Index.
Of the 394 patients included in the study, 196 received golimumab and 198 were randomized to placebo therapy. Investigators noted patients receiving golimumab achieved a greater PASI 75 response rate than patients on placebo therapy at week 24. At week 52, the PASI 75 response rate was maintained in patients who continued treatment and increased in those who switched from placebo to golimumab at week 24 (71.9% and 60.6%, respectively).
In regard to DLQI, the mean decrease at week 24 was greater in the golimumab group than placebo (−8.1 vs −1.9, P<0.001) and at 52 weeks, that improvement was maintained in golimumab patients while it increased in crossover patients (-7.8 versus -5.8).
In patients where mNAPSI was assessed, the mean decrease in mNAPSI score was greater with golimumab versus placebo at week 24. This effect was maintained in golimumab patients out to week 52 and patients who switched from placebo saw improvements in mNAPSI score after switching.
For more on the clinical implications of the study results, MD Magazine® sat down with lead investigator from the GO-VIBRANT trial Elaine Husni, MD, MPH, vice chair of rheumatology at the Cleveland Clinic, between sessions at ACR 2019.
MD Mag: What were the results of your study examining quality of life improvements with golimumab in psoriatic arthritis patients?
Husni: We're so excited that there are so many treatments for psoriatic arthritis. It's really been an explosion of therapies that are available. I'd like to focus on golimumab—it's one of the anti-TNF inhibitors, which is also shown great efficacy and patients with psoriatic arthritis, but what's really a specialist focusing on health-related quality of life.
So, what do I mean by that? So, things that patients experience that are beyond just measuring skin and joint measures, but measuring how their health and their quality of life is really important. What I really love about this particular study, is it's concentrated in the first 24 weeks and then out to 52 weeks looking at specifically health-related quality of life measures and it's shown that these are sustainable throughout the treatment period for golimumab.
So, we see in this study over 400 patients that were treated with golimumab show that their health-related quality of life was able to be sustained up to 52 weeks. I think this is really exciting. It adds another layer of therapeutic improvements that a patient with chronic disease with psoriatic arthritis can achieve.