Tocilizumab holds firm as steroid-sparing agent in giant cell arteritis
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Tocilizumab, the one biologic therapy that has FDA approval for giant cell arteritis, has shown ongoing efficacy in keeping patients in remission and off steroids, according to a pair of presenters at the Biologic Therapies Summit.
While glucocorticoids have been the “mainstay for GCA” for more than 7 decades, their adverse effects have pushed the rheumatology community toward biologics like tocilizumab (Actemra, Genentech), according to Kenneth J. Warrington, MD, of the department of rheumatology at the Mayo Clinic in Rochester, Minnesota.
“Every patient [with GCA] should receive education and assessment for treatment with tocilizumab,” Warrington said in his presentation.
The talk covered patient populations that may most benefit from tocilizumab therapy; strategies for tapering glucocorticoids in patients who are showing response when tocilizumab is added to their regimen; and strategies for both long-term use and eventual tapering of tocilizumab for patients in sustained remission.
Findings from the Giant Cell Arteritis Actemra (GiACTA) trial served as the key reference point, along with a number of smaller post-marketing studies that have provided a look at real-world outcomes with the drug.
In terms of patient populations, Warrington suggested that those with newly diagnosed GCA and those who have relapsed on glucocorticoids are best positioned to respond to tocilizumab. Conditional recommendations from the American College of Rheumatology and Vasculitis Foundation support these suggestions. These guidelines have not yet been published, but a draft was presented at ACR 2020.
There is another important clinical consideration when choosing a steroid and/or tocilizumab regimen, according to Warrington. “When we consider the patient most likely to benefit from tocilizumab, we need to consider the adverse effects of glucocorticoids,” he said.
Glucocorticoids should be used with caution in individuals at risk for fracture, diabetes, osteoporosis, glaucoma, serious infections or hospitalization. “Women have a higher risk of relapse than men,” Warrington added.
However, not every patient is an ideal candidate for tocilizumab therapy. Contraindications include active infection, risk of gastrointestinal perforation, active hepatic disease, angiosarcoma risk and established cytopenias, according to Warrington.
Turning to the subject of glucocorticoid tapering, Warrington suggested that for patients with sustained remission on combination therapy, glucocorticoids may be tapered in an “accelerated” fashion over a 6-month period. A longer taper is recommended in patients who are less stable.
Real-world data have underscored both the GiACTA trial results and the ACR/VF recommendations. Findings from a group in Spain showed that 90% of patients treated with tocilizumab achieved remission, while a study from Massachusetts General Hospital, in Boston, demonstrated that the drug led to reduced flares and reduced prednisone doses.
Prior to GiACTA, there was some concern that a reduction in glucocorticoid dose in favor of tocilizumab would expose patients to visual ischemia risk. However, the study proved that this fear is unwarranted. “The bottom line here is that despite using an accelerated glucocorticoid taper in GCA, the risk of vision loss with tocilizumab remains very low,” he said.
If there is a shortcoming with GiACTA, it is that the blinded primary endpoint follow-up concluded at 52 weeks. Beyond that, longer-term data are necessary to guide clinical decision making.
Warrington said that early data are showing a signal in terms of when and how to taper tocilizumab. “GCA flares may occur within a few months after tocilizumab discontinuation, some may occur many months later,” he said.
In general, Warrington suggested that after 12 to 18 months of treatment with tocilizumab, followed by a slow taper using a reduced dosing interval, patients may sustain remission. He added that tocilizumab has shown efficacy in patients who experience increased disease activity. “In patients who relapse, they go back on tocilizumab and it works,” he said.
“The days of prednisone monotherapy are ending,” Warrington concluded. “We are now in the era of targeted biologic therapies.”
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Warrington K. When should biologic agents be introduced in giant cell arteritis and for how long should they be given? Presented at: Biologic Therapies Summit IX; May 21-23, 2021 (virtual meeting).
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