A Randomized, Double‐Blind Trial of Abatacept (CTLA‐4Ig) for the Treatment of Giant Cell Arteritis

Abstract

Objective To compare the efficacy of abatacept to placebo for giant cell arteritis (GCA). Methods In this multicenter trial, patients with newly-diagnosed or relapsing GCA were treated with abatacept 10 mg/kg IV on days 1, 15, 29, week 8, together with prednisone. At week 12, patients in remission underwent a double-blinded randomization to continue monthly abatacept or switch to placebo. Patients in both study arms received a standardized prednisone taper with discontinuation of prednisone at week 28. Patients remained on their randomized assignment until meeting criteria for early termination or until 12 months after enrollment of the last patient. The primary endpoint was duration of remission (relapse-free survival). Results Forty-nine eligible patients with GCA were enrolled and treated with prednisone and abatacept; forty-one reached the week 12 randomization and underwent a blinded randomization to abatacept or placebo. Prednisone was tapered using a standardized schedule reaching 20 mg daily at week 12 with discontinuation in all patients at week 28. The relapse-free survival at 12 months was 48% for those receiving abatacept and 31% for those receiving placebo (p=0.049). A longer median duration of remission was seen with abatacept (9.9 months) compared to placebo (3.9 months, p=0.023). There was no difference in the frequency or severity of adverse events between treatment arms, including infection. Conclusions In patients with GCA the addition of abatacept to a treatment regimen with prednisone reduced the risk of relapse and was not associated with a higher rate of toxicity compared to prednisone alone.

Large vessel vasculitis: is it more common than usually assumed?

“…LVV, traditionally considered a rare condition, is currently recognized more often for two main reasons. On the one hand, new vascular imaging techniques, including MRI angiography, TC angiography, ultrasound (US), and PET-CT ( Figure 1) have made its diagnosis more accessible (2); on the other hand, new therapies, the anti IL-6 receptor monoclonal antibody tocilizumab (3) and the CTLA-4 Ig abatacept (4), have shown promising results in GCA and are calling more attention to this condition.…”

Development of a Core Set of Outcome Measures for Large-vessel Vasculitis: Report from OMERACT 2016

“…In particular, four major clinical trials examining the role of various biologic medicines are of interest: A randomized trial of abatacept for the treatment of LVV (36, 37), a phase 2 randomized trial of tocilizumab in GCA (18) and TAK (38), a phase III randomized trial of tocilizumab in GCA (GiACTA) (39), and a phase III randomized trial of sirukumab in GCA (SIRRESTA; ClinicalTrials.gov Identifier: NCT02531633). Other investigational drugs are being explored for the treatment of LVV such as uztekinumab (NCT02955147), baricitinib (NCT03026504), and anakinra (NCT02902731).…”

Giant cell arteritis

“…At week 12, 41 patients in remission underwent a double-blind randomization to continue monthly abatacept or switch to placebo. Both groups received standard regimen with prednisolone [107]. The relapse-free survival at 12 months was estimated to be 48% for those receiving abatacept and 31% for those receiving placebo (p ¼ 0.049).…”