Genentech launches trial of Actemra in giant cell arteritis

Genentech announced the launch of a new trial, GiACTA, of its interleukin-6 inhibitor as a “steroid-sparing agent” in patients with giant cell arteritis at the European League Against Rheumatism Annual European Congress of Rheumatology.

“Clinical trials have thus far failed to demonstrate any consistent effect of ‘steroid-sparing’ medications for this disease,” John H. Stone, MD, MPH, told Healio.com/Rheumatology. “In recent years, unsuccessful trials have been performed with methotrexate, infliximab, and adalimumab.”

John H. Stone

Researchers have enrolled 200 of the 250 projected patients with giant cell arteritis (GCA) with the goal of comparing characteristics and response to treatment of newly onset patients with GCA to patients with relapsing GCA upon enrollment.

To be eligible, patients must be over age 50 years, have a history of an erythrocyte sedimentation rate of 50 mm/hr or higher, display well defined cranial symptoms or polymyalgia rheumatica and have a positive temporal artery biopsy or large vessel imaging to confirm the diagnosis of GCA. To date, mean age of patients enrolled is 69 years and 75% are women. About half of patients have new onset GCA, and the most common comorbidity is hypertension (53%).

Patients in the double-blind, placebo-controlled study will be randomized to one of four arms. One group will receive 162 mg subcutaneous Actemra (tocilizumab, Genentech) once a week while tapering prednisone for 6 months. A second group with receive 162 mg tocilizumab subcutaneously every 2 weeks during a 6-month prednisone taper. The third and fourth groups will receive prednisone only while tapering for 6 or 12 months, respectively.

“GiACTA is the first clinical trial in any disease to employ a blinded corticosteroid-tapering regimen,” Stone said. “This design feature was essential because of the primary goal of the trial: to demonstrate that tocilizumab is an effective steroid-sparing agent in GCA.”

Part one of the GiACTA trial will continue for 52 weeks with the goal of sustained remission in patients without the use of prednisone, according to Stone, who said the trial will be evaluated after the final enrolled patient randomized into the trial reaches 52 weeks of treatment and follow-up. – by Shirley Pulawski

Reference:

Tuckwell K, et al. Paper #FRI0248. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology. June 10-13, 2015; Rome.

Disclosure: Tuckwell is an employee of Roche. Stone receives grant/research support from Roche. Please see the full study for a list of all other authors’ relevant financial disclosures.