GHENT, Belgium — The tumor necrosis factor (TNF) inhibitor golimumab (Simponi, Janssen Biotech) is effective in the treatment of very early peripheral spondyloarthritis, and safety is similar to that seen in other spondyloarthritis conditions, according to new research.
"We found that anti-TNF treatment in very early peripheral spondyloarthritis — classified according to Assessment of Spondyloarthritis International Society [ASAS] criteria — leads to high rates of complete remission and other outcomes, and low rates of spontaneous remission," said Philippe Carron, MD, from the Department of Rheumatology at Ghent University Hospital in Belgium.
He presented the findings here at the International Congress on Spondyloarthritides 2016.
Golimumab is a human monoclonal antibody that targets TNF-alpha. It is currently approved by the US Food and Drug Administration for the treatment of moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Peripheral spondyloarthritis is associated with a high rate of spontaneous remission, but little is known about the natural evolution of the disease, particularly in the early stages, Dr Carron explained. It is also not known if there is a need for the intensive therapy that is commonly used to treat patients with rheumatoid arthritis or axial spondyloarthritis.
To investigate these issues, Dr Carron and his colleagues enrolled 60 patients in the CRESPA — Clinical Remission in Patients with Early Peripheral Spondyloarthritis According to Assessment of Spondyloarthtiris Criteria — trial (NCT01426815).
All patients had a diagnosis of active but very early peripheral spondyloarthritis, defined by ASAS criteria, and symptom duration was less than 12 weeks. Patients were randomized to a self-administered injection of golimumab 50 mg every 4 weeks or to placebo.
Medication was withdrawn when patients demonstrated complete remission on two consecutive visits (which occurred at weeks 12, 24, 36, or 48).
Patients who tested positive for rheumatoid factor, has a diagnosis of fibromyalgia, or who had any previous exposure to medications such as disease-modifying antirheumatic drugs (DMARDs), TNF inhibitors, or corticosteroids were excluded from the study.
Demographic characteristics, disease characteristics, or spondyloarthritis features were similar in the golimumab and placebo groups.
Nonsteroidal anti-inflammatory drugs (NSAIDs) were permitted in the placebo group, and approximately 80% of all patients were using NSAIDs at randomization, Dr Carron reported.
After 24 weeks of treatment, 30 of 40 patients in the golimumab group and four of 20 patients in the placebo group achieved the primary end point of clinical remission (75% vs 20%; P < .001). One patient dropped out of the trial after 24 weeks of treatment.
The results were similar after 12 weeks of treatment, when 28 of 40 patients in the golimumab group and three of 20 patients in the placebo group achieved clinical remission (70% vs 15%; P < .001).
Fewer patients in the golimumab group than in the placebo group had to receive rescue treatment (10% vs 50%), but there were no significant differences in rates of adverse events between the two groups.
Table 1. Improvements in Peripheral Spondyloarthritis Response Criteria of at Least 40%
|Time Point||Golimumab Group, %||Placebo Group, %|
After as little as 4 weeks of treatment, significant changes were seen with golimumab.
Table 2. Changes After as Few as 4 Weeks of Treatment
|Outcome||Golimumab Group||Placebo Group||P Value|
|Tender joint count|
|Swollen joint count|
After treatment withdrawal, 31 patients remained in drug-free remission at a follow-up of approximately 9 months (maximum follow-up, 55 months). Of the remaining 28 patients, 17 relapsed after treatment discontinuation and 11 experienced major improvement at week 48 but never reached clinical remission. These 28 patients were included in the open-label CRESPA extension study, and received golimumab 50 mg every 4 weeks for 2 years.
This study offers needed evidence supporting the effect of golimumab on peripheral spondyloarthritis, Dr Carron told Medscape Medical News.
"Golimumab is only approved for axial spondyloarthritis and psoriatic arthritis; this is the first trial with golimumab done in peripheral spondyloarthritis," he said.
"Furthermore, taking into account trials of other anti-TNF agents, this is the first study that was performed in a population with peripheral spondyloarthritis with a symptom duration of less than 12 weeks," he added.
"The paradigm that treating early disease with aggressive therapy leads to better outcomes is preserved in peripheral spondyloarthritis," he noted.
This study reflects a growing interest in the potential efficacy of TNF inhibitors for expanding indications, said Robert Landewé, MD, PhD, from the Amsterdam Rheumatology and Immunology Center, who is copresident of the congress and president of the ASAS.
"Peripheral spondyloarthritis is a relatively new indication, and some companies are exploring whether it makes sense to get an indication for treatment with biologics," he told Medscape Medical News.
"We have now seen several trials, including this one, and it probably makes sense that it does work in peripheral spondyloarthritis," he explained.
In fact, the phase 3 ABILITY-2 trial showed similar improvements with the TNF inhibitor adalimumab in patients with peripheral spondyloarthritis (Arthritis Rheumatol. 2015;67:914-923).
But unlike in the CRESPA trial, in ABILITY-2 and in an earlier trial of adalimumab, patients with a history of psoriasis or psoriatic arthritis and ankylosing spondylitis were excluded, Dr Carron pointed out.
Peripheral spondyloarthritis tends to fall through the cracks in terms of treatment, and reimbursement for TNF inhibitors is often not provided unless a more established diagnosis, such as rheumatoid arthritis, is made, Dr Landewé explained.
"This is not a big group, but it's an extremely important group," he added. "Many patients with peripheral spondyloarthritis take NSAIDs for a while but then they become insufficient. There is then a need for a more effective therapy."
"Patients can then be treated with a conventional DMARD, and a TNF inhibitor should probably be started," he said.
This study was sponsored by Janssen. Dr Carron and Dr Landewé have consulted for Janssen.
International Congress on Spondyloarthritides (SPA) 2016: Abstract O4. Presented September 16, 2016.
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Cite this: Golimumab Effective for Early Peripheral Spondyloarthritis - Medscape - Sep 18, 2016.