Simponi Effective, Including in Patients Who Tried Other TNF Blockers, Data Show

Simponi (golimumab) — a TNF inhibitor — is an effective therapy for people with ankylosing spondylitis (AS) and other chronic inflammatory conditions, regardless of pre-treatment with other TNF inhibitors, real-world data from Germany suggested.

While the best results were seen in patients given Simponi as a first-line treatment, these findings support switching to Simponi when other TNF inhibitors have failed, even though they target the same pathways.

The study, “Golimumab as the First-, Second-, or at Least Third-Line Biologic Agent in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis: Post Hoc Analysis of a Noninterventional Study in Germany,” was published in the journal Rheumatology and Therapy.

TNF inhibitors such as Simponi (by Janssen) are a therapeutic mainstay for chronic inflammatory conditions, including AS, rheumatoid arthritis (RA), and psoriatic arthritis (PsA).

This type of biological disease-modifying anti-rheumatic drug reduces inflammation and may stop disease progression by blocking the effects of tumor necrosis factor (TNF), a key inflammatory mediator.

While clinical trials have shown Simponi’s benefits in patients treated with a biologic therapy for the first time, evidence of its effectiveness in people previously treated with other biologic agents is still lacking.

To address this gap, researchers evaluated the therapeutic effects of Simponi as a first-, second-, or at least third-line biologic therapy in AS, RA, and PsA in a real-world setting.

They analyzed disease activity data of a completed study called GO-NICE — non-Interventional Clinical Evaluation with Golimumab (NCT01313858) — which evaluated Simponi’s safety and effectiveness in adults with one of three conditions. Simponi (50 mg) was given through an under-the-skin injection once a month for two years.

Disease activity was assessed at treatment initiation and every three months using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in AS patients, the 28-Joint Disease Activity Score in RA patients, and the Psoriatic Arthritis Response Criteria index in people with PsA.

GO-NICE data from all three groups of patients previously showed that Simponi treatment resulted in substantial and sustained reductions in disease activity and fatigue, as well as improvements in quality of life and functional capacity.

In the updated analysis, the team divided 1,454 participants — 480 AS patients, 473 RA patients, and 501 PsA patients — into three groups according to the number of previous biologic therapies: none (first-line group), one (the second-line group), and at least two (third-line group).

The most commonly used biologic agents in previous treatments were Humira (adalimumab), Enbrel (etanercept) and infliximab (brand names, Remsima and Remicade). All three therapies are TNF inhibitors.

Among AS patients, 292 received Simponi as first-line, 130 as second-line, and 58 as an at least third-line biologic therapy. AS patients’ mean age ranged from 42.5 to 45.3. In turn, the time since diagnosis was 9.4 years for the first-line group, 9.8 years for the second-line group, and 12.4 years for the third-line group.

Most AS patients were positive for HLA-B27, a marker for inflammatory arthritis of the spine and joints, and 162 had extra-articular manifestations (outside joints) — ranging from 31.2% in the first-line group to 43% in the third-line group.

Notably, AS patients receiving Simponi as at least a third-line therapy had higher disease activity than participants in the other two groups at the study’s start.

After two years on Simponi, disease activity was significantly reduced — between two and three points in the mean BASDAI scores — in all three AS patient groups. The benefits were more pronounced in patients receiving Simponi as first-line biologic therapy.

Simponi also led to significant therapeutic benefits in all groups of RA and PsA patients, with participants in the first-line groups showing the greatest improvements.

“Better outcomes were achieved in biologic-naïve patients [those in the first-line group], especially in patients with PsA, than in second-line therapy, and to a somewhat lesser effect in third-line therapy,” the researchers wrote.

The findings suggested that Simponi is an effective therapy in adults with AS, RA, or PsA, irrespective of pre-treatment with biologic agents.

Data also highlighted that it is appropriate to switch to Simponi after failure of another TNF inhibitor, “despite the fact that the alternative [TNF inhibitor] targets the same molecular and inflammatory pathways,” the scientists added.

However, caution is warranted when generalizing the results to other countries, the team said, due to potential differences in healthcare systems, treatment patterns, and social effects.