Golimumab reduces PsA signs, symptoms through one year
Intravenous golimumab, in doses of 2 mg per kg, reduced the signs and symptoms of psoriatic arthritis through1 year, with improvements in health-related quality of life maintained throughout that time, according to findings published in Arthritis Care & Research.
“In the phase 3 GO-VIBRANT study, adult patients with active PsA had 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,” M. Elaine Husni, MD, MPH, director of the Arthritis Center at the Cleveland Clinic, and colleagues wrote. “Improvements in health-related quality of life (HRQoL) were also greater for patients in the golimumab group. Adverse events through week 24 were consistent with the known safety profile of IV golimumab.”
To analyze the safety and efficacy of IV golimumab (Simponi, Janssen) among patients with active PsA through 1 year, Husni and colleagues conducted the GO-VIBRANT Phase 3 trial, a randomized placebocontrolled study of 480 participants. The researchers randomly selected 241 participants to be treated with 2 mg per kg of IV golimumab, with 239 receiving placebo, at baseline as well as at weeks 4, 12 and 20. Placebo crossover to golimumab occurred at weeks 24, 28 and every 8 weeks thereafter.
The researchers assessed efficacy through week 52 using the ACR 20/50/70 improvement criteria, as well as the Health Assessment QuestionnaireDisability Index (HAQDI) and the Psoriasis Area and Severity Index (PASI75). They measured radiographic disease progression through the PsAmodified van der HeijdeSharp (vdHS) score. Safety was assessed through week 60.
According to Husni and colleagues, 76.8% of patients in the golimumab group, and 77% in the placebocrossover group, achieved an ACR20 response by week 52. Also during this time, 58.1% of those in the treatment group, and 53.6% who received placebo, achieved an ACR50 response, while 38.6% who received golimumab and 33.9% in the placebo group demonstrated an ACR70 response.
In cases where more than 3% of the patient’s body surface area was impacted by the disease, 71.9% of participants in the golimumab group, compared with 60.6% of those in the placebo-crossover group, demonstrated a PASI75 response by week 52. In addition, the mean change from baseline in total vdHS was –0.5 among participants treated with golimumab, compared with 0.8 for those in the placebo-crossover group.
Regarding safety, 50.9% those treated with golimumab experienced at least one adverse event, while 5.2% had one or more serious adverse events. Among the patients treated with golimumab, there were two malignancies, one death and no opportunistic infections.
“The GO-VIBRANT study was not powered to detect rare safety events and follow-up was limited to approximately 1 year,” Husni and colleagues wrote. “However, the totality of the results through 1 year of the GO-VIBRANT study show a durable response to IV golimumab 2 mg/kg across several clinical efficacy, HRQoL, and radiographic endpoints with no new safety signals.” – by Jason Laday
Disclosures : Husni reports consulting fees, speaking fees, and/or honoraria from AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, and Novartis. Please see the full study for additional authors’ disclosures.