Medicines

Future move beyond IL-6 inhibition in GCA


The IL-17A inhibitor secukinumab has shown a high sustained remission rate in biologic-naive patients with new onset or relapsing giant cell arteritis (GCA).

Dr Jens Thiel, from the University Hospital Freiburg in Germany, told the ACR Convergence meeting that IL-6 inhibition was currently the only glucocorticoid-sparing treatment available.

“There is experimental and preclinical data that point towards a role of IL-17A in the pathogenesis of GCA and therefore IL-17A inhibition, by blocking vascular inflammation, is a potentially new therapeutic target for GCA.”

Secukinumab was also safe and effective in other IL-17A driven diseases such as psoriatic arthritis.

A phase 2 proof-of-concept study presented in the Late-Breaking Abstract Session of the meeting, compared weekly (4 weeks) then monthly (48 weeks) 300 mg secukinumab versus placebo in 52 patients who were also on a fixed 26-week prednisolone taper.

Patients were mostly women (67%) with a mean age of 73 years and new-onset disease (81%).

The TitAIN study found sustained remission, defined as the absence of flare and adherence to the prednisolone taper, was achieved in 70.1% of secukinumab patients and 20.3% of controls at Week 28 (OR 9.31).

In secondary endpoints, the rate of sustained remission was 59.3% in the active arm compared to 8.0% in the controls at Week 52.

The median time to first GCA flare from baseline was not reached in secukinumab-treated patients versus 197 days in the patients receiving placebo.

Total cumulative prednisolone dose between baseline and Week 52 was 2,841 mg in the secukinumab-treated patients compared to 3,375 mg in the group receiving placebo.

Dr Thiel said that treatment-emergent adverse events were high in both groups of patients (100% v 96%) including hypertension, nasopharyngitis, headhache and UTIs.

There were no new or unexpected safety signals with secukinumab.

Serious adverse events were reported in 22.2% and 44.0% of GCA patients, with AEs leading to discontinuation of treatment in two patients in each patient group.

There was also one death in each patient group.

Given the need for more glucocorticoid-sparing agents in GCA, Dr Thiel said the findings support further development of secukinumab as a future potential treatment option.

He added that a phase 3 study has just started recruiting its first patients in the US.

Disclosures: The study was supported by Novartis Pharmaceuticals. Dr Thiel has received honorarium and research grants from pharmaceutical companies including Novartis.

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