medwireNews: Preliminary study results suggest that the interleukin (IL)-12/23 inhibitor ustekinumab may be a promising treatment option for patients with giant cell arteritis (GCA).
Glucocorticoids, the mainstay of therapy for GCA, are “required in high doses for prolonged periods,” and “serious glucocorticoid-related complications such as fractures, sepsis, diabetes mellitus and hypertension occur in up to 95% of GCA patients,” say the study authors.
Therefore, a “proven safe and effective alternative or adjunct to glucocorticoids remains an urgent unmet need in GCA,” they add.
Richard Conway (St Vincent’s University Hospital, Dublin, Ireland) and co-investigators explain that although the pathophysiology of GCA remain incompletely understood, IL-12 and IL-23 are thought to have a dual role in the underlying inflammatory pathways, making ustekinumab “a potentially attractive treatment option.”
In the open-label study, reported in Seminars in Arthritis & Rheumatism, 25 patients with glucocorticoid-refractory GCA – defined as the inability to taper glucocorticoids due to recurrence of symptoms after an initial treatment response – were given 1 year of treatment with ustekinumab at a dose of 90 mg administered subcutaneously at baseline, week 4, and every 12 weeks thereafter.
The median prednisolone dose decreased significantly over the study period, from 20 mg/day at baseline to 5 mg/day at the 1-year follow-up, and 24% of participants stopped taking prednisolone altogether. None of the patients experienced a GCA relapse while receiving ustekinumab treatment.
Eight patients reported adverse events (AEs), six of which were considered by the investigators to be possibly related to ustekinumab. The majority of AEs were minor infections, and three participants discontinued the study drug due to AEs (one case each of recurrent respiratory tract infection, alopecia, and non-dermatomal limb paraesthesia), all of which resolved after discontinuation.
Conway and team caution that their study was limited by its open-label nature and the lack of a control group. Moreover, they note that patients with refractory disease were chosen for inclusion in the study given the experimental nature of ustekinumab in GCA, and therefore “[t]here are also caveats in extrapolating the current results to the entire population of patients with GCA.”
And they conclude that “the efficacy and safety of ustekinumab will require confirmation in a double-blind [randomized controlled trial] before it can be recommended for wider use in patients with GCA.”
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