Intravenous golimumab shows promise in PsA
medwireNews: Intravenous golimumab is a promising treatment option for patients with psoriatic arthritis (PsA), results of the placebo-controlled GO-VIBRANT trial suggest.
Golimumab is currently the only anti-tumor necrosis factor (TNF) therapy with both subcutaneous and intravenous formulations, explain the study authors, noting that subcutaneous golimumab is approved for the treatment of PsA, rheumatoid arthritis (RA), and ankylosing spondylitis, whereas the intravenous formulation is approved for RA only.
In their phase III trial, Elizabeth Hsia (Janssen Research & Development, Spring House, Pennsylvania, USA) and co-investigators randomly assigned 480 PsA patients from 11 countries to receive treatment with 2 mg/kg intravenous golimumab or placebo at weeks 0, 4, 12, and 20. More than two-thirds of participants (70.0%) were receiving concomitant methotrexate at baseline, and approximately a quarter (27.7%) were taking low-dose oral corticosteroids.
The team found that 75.1% of 241 patients receiving intravenous golimumab achieved at least a 20% improvement in ACR criteria (ACR20) at week 14, compared with 21.8% of 239 patients in the placebo group, a significant difference.
This difference in response rate was observed as early as week 2, with ACR20 response rates of 45.6% and 7.5% in the golimumab and placebo groups, respectively, and was maintained for up to 24 weeks, at which time a corresponding 76.8% and 24.3% of patients had an ACR20 response.
Furthermore, patients receiving golimumab were significantly more likely to have a skin response as measured by a 75% improvement in Psoriasis Area and Severity Index scores at week 14 (59.2 vs 13.6%), and had less radiographic progression at week 24 than those in the placebo group (change from baseline in modified Sharp/van der Heijde scores: –0.4 vs 2.0 points).
At the 24-week follow-up, 46.3% of participants in the golimumab group had experienced at least one adverse event, compared with 40.6% of those in the placebo group. Infections were the most commonly reported adverse event, affecting 18.8% and 15.5% of patients, respectively.
The observed adverse events “were consistent with results of previous trials of [subcutaneous] and [intravenous] golimumab in patients with rheumatologic diseases as well as the safety profiles of other anti-TNF agents,” say the researchers in Arthritis & Rheumatology.
However, “[i]t should be noted that this study was not powered to detect rare safety events,” they caution.
Hsia and colleagues suggest that the use of intravenous golimumab could “allow a more individualized treatment plan for some patients.” While some people prefer administering treatment at home, others may experience anxiety related to self-injection or “prefer the additional interactions with health care providers when receiving an [intravenous] medication,” they believe.
The team notes that the GO-VIBRANT study will continue for 1 year, and patients in the placebo group will cross over to receive intravenous golimumab after week 24.
medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group