Novartis Initiates Phase 3 Trial in AS Comparing Cosentyx to Adalimumab Biosimilar

Novartis recently initiated a Phase 3 clinical trial comparing its FDA-approved therapy Cosentyx (secukinumab) with GP2017 — an adalimumab biosimilar — in ankylosing spondylitis (AS) patients.

The trial, called SURPASS (NCT03259074), is a head-to-head study testing the benefit of Cosentyx to the biosimilar GP2017 in reducing the progression of spinal bone damage.

The study is currently enrolling adult AS patients. For more information, please visit this link. Interested people can also email Novartis at [email protected].

Cosentyx is a specific inhibitor of IL-17A, a pro-inflammatory cytokine — a molecule released by immune cells — crucially involved in AS and psoriatic arthritis.

In AS, augmented levels of IL-17A are associated with inflammation of the sacroiliac joint — which connects the bottom of the spine with the pelvis — and new spinal bone formation, with severe cases progressing to permanent spinal fusion (connection of spinal vertebrae with subsequent loss of mobility).

“Head-to-head trials deliver the most robust data helping to advance clinical practice and are key to clinical decision making,” Robert Landewé, MD and PhD, a professor of rheumatology in the Netherlands, said in a press release. “These data would add to the body of evidence to underline the benefit of different biologic pathways for physicians.”

The medication is globally approved to treat AS, psoriatic arthritis, and moderate-to-severe plaque psoriasis.

“Cosentyx is backed by strong clinical efficacy and safety data and already has supported more than 125,000 patients worldwide,” said Vas Narasimhan, MD, the global head of drug development and chief medical officer at Novartis.

Adalimumab, sold under the trade name Humira and others, is a medication for AS, plaque psoriasis, rheumatoid arthritis, Crohn’s disease, and other conditions. The drug targets the pro-inflammatory tumor necrosis factor-alpha.

GP2017, a proposed adalimumab biosimilar developed by Sandoz, is being tested in the head-to-head SURPASS trial.

SURPASS is the largest trial evaluating a biologic therapy for AS. It is a one-year study with three treatment groups, including two doses of subcutaneous Cosentyx (150 mg and 300 mg) and one dose of the biosimilar GP2017 (40 mg) in active ankylosing spondylitis patients.

Novartis is currently also investigating the 300 mg dose of Cosentyx in the Phase 4 ASLeap clinical trial (NCT03350815) in AS patients who did not achieve symptom remission after 16 weeks of treatment with 150 mg.

The completed Phase 3 MEASURE I study (NCT01358175) demonstrated that treatment with Cosentyx resulted in no disease progression at four years in a vast majority of the AS patients analyzed.

In the SURPASS trial, researchers will primarily analyze the percentage of patients with no structural deterioration of the spine at two years. Slowing the progression of spinal damage is a key attribute of potential AS treatments. Among other assessments, the team will also analyze inflammation through magnetic resonance imaging (MRI).

As an additional part of its rheumatology program for Cosentyx, the company is also conducting the Phase 3b EXCEED trial (NCT02745080), which compares Cosentyx with AbbVie’s Humira (adalimumab) in patients with psoriatic arthritis.

Patients with AS and psoriatic arthritis often suffer from persistent pain and fatigue, and may experience long-term mobility loss.

“These patients deserve the best treatment possible and we are hopeful that the EXCEED and SURPASS trials will provide valuable answers for doctors and patients in their decision making,” Narasimhan said.