Support for glucocorticoid-sparing effect of tocilizumab in giant cell arteritis
medwireNews: Tocilizumab monotherapy following an ultra-short pulse of glucocorticoid treatment may be effective for inducing and maintaining remission in patients with new-onset giant cell arteritis (GCA), suggest preliminary study findings.
“As a proof-of-concept study, our data do not allow proposing clinical recommendations,” highlighted presenter Lisa Christ (Inselspital, Bern University Hospital, Switzerland) at the EULAR 2021 Virtual Congress.
However, the GUSTO study findings did show that at the 24-week interim analysis 11 out of 12 patients with GCA had achieved remission after an average 10.6 weeks and 10 were relapse free. This was following a treatment regimen comprising methylprednisolone 500 mg for just 2 days, one intravenous infusion of tocilizumab 8 mg/kg on day 3 and then weekly subcutaneous tocilizumab 162 mg for the remainder of the 52-week study.
Christ noted that “the study did not achieve its primary endpoint” of remission within 31 days without relapse at 24 weeks, which was achieved by only three patients, but at the final 52-week analysis, 14 out of 18 patients were in remission, after an average 11.1 weeks, and 13 were relapse free.
The data therefore show “a slow remission-inducing as well as lasting remission-maintaining effect of tocilizumab after an ultra-short pulse of glucocorticoid in patients with newly diagnosed GCA,” she commented.
Christ explained the rationale for the study, including the “numerous side effects” associated with long-term use of glucocorticoids and the finding of a “glucocorticoid-sparing effect of tocilizumab of at least 50% in GCA” in two previous trials.
The study participants all had C-reactive protein levels above 25 m/L and Christ pointed out that 61% of patients had received prior glucocorticoid treatment although only for a median of 1 day (maximum of 10 days and maximum dose of 60 mg/day), 83% had cranial symptoms, and 72% positive histology.
There were three non-responders to treatment at the 52-week assessment who required rescue glucocorticoid treatment. Of these, one had polymyalgia rheumatic symptoms and two had cranial symptoms, including one patient with new-onset anterior ischemic optic neuropathy that developed 15 days after the glucocorticoid pulse and led to vision loss at day 27 despite the patient receiving a high dose of glucocorticoids.
Three patients experienced serious adverse events – diverticulitis, oral aphthous lesion, and nausea – that led to two patients discontinuing treatment, and one patient had an increased tocilizumab interval due to neutropenia.
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