Intravenous golimumab produced lasting improvements in health-related quality of life over 52 weeks of treatment in patients with psoriatic arthritis, researchers reported on November 11 at the American College of Rheumatology annual meeting in Atlanta.
These findings are based on an analysis of the randomized GO-VIBRANT study in which psoriatic arthritis patients successfully achieved ACR 20/50/70 after 24 weeks of treatment with intravenous golimumab.
In this follow-up study, M. Elaine Husni, MPH, of the Cleveland Clinic, examined whether patients were able to achieve and maintain improvements in quality of life.
The study included 480 adults with active psoriatic arthritis who were randomized to either 2 mg/kg infusion of golimumab at week zero and four, then every eight weeks or they were assigned to placebo through week 20. At 24 weeks, the trial met its primary endpoints, with patients in the golimumab group showing significantly more improvement in ACR20, ACR50, or ACR70 response rates versus the placebo group. Safety was comparable to other TNF inhibitors.
Investigators assessed health-related quality of life (HRQoL) at weeks zero, eigh, 14, 24, 36, and 52 using standardized measures. These included the Health Assessment Questionnaire-Disability Index (HAQ-DI), Short-Form-36 Physical and Mental Component Summaries (SF-36 PCS/MCS), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, EuroQol-5D visual analog scale (EQ-VAS), and Dermatology Life Quality Index (DLQI).
“Health-related quality of life is a newer measure that we’re using as rheumatologists because we want to be able to comprehensively evaluate how the disease affects patients using patient-reported outcomes,” Dr. Husni said.
The golimumab and placebo groups had comparable HRQoL at baseline. At 24 weeks, those in the active treatment arm had greater improvements in all HRQoL measures and were more likely to have minimal clinically important improvements from baseline in HAQ (≥0.35 points), SF-36 (≥5points), and FACIT-fatigue (≥4 points) versus the placebo group.
Twelve weeks after the placebo group crossed over to golimumab infusion (week 36), patients achieved statistically comparable improvements in HRQoL measures. Both groups sustained improvements at week 52. Dr. Husni and colleagues reported earlier this year that by week 52 the two groups also showed comparable improvements in measures of skin and joint disease.
“In addition to sustainable skin and joint improvements there was also lasting improvement in over-all well-being. Changes in health-related quality of life happen fairly fast after patients start medication, something we were able to demonstrate even in the group that didn’t start with golimumab,” she said.
Dr. Husni reported disclosures related to Abbvie, AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, UCB, Lilly, Bristol-Myers Squibb, Genentech, Janssen, and Research & Development, LLC.
“1204 - Improvements in Health-Related Quality of Life in Psoriatic Arthritis Patients Treated with Intravenous Golimumab, an Anti-TNFa Monoclonal Antibody: 1-Year Results of a Phase III Trial.” M. Elaine Husni, MD, MPH, 9 a.m., Monday, Nov 11. American College of Rheumatology 2019 annual meeting, Atlanta.