Efficacy and tolerance of methotrexate in a real-life monocentric cohort of patients with giant cell arteritis

Giant cell arteritis (GCA) is the most frequent large-vessel systemic vasculitis characterized by cranial and extracranial involvement and mainly affects women over 50 years of age. Given the risk of potentially irreversible ophthalmological and cerebral damage, GCA represents a diagnostic and therapeutic emergency [1], [2], [3].

At diagnosis, European and American guidelines recommend using a high dose of glucocorticoids (GCs) and progressively tapering dosages [2,4]. Glucocorticoids have a prompt and effective effect for disease control. However, GC-related adverse events (AEs) are frequently noted and include an increased risk of infections, osteoporotic fractures, induced diabetes and weight gain, neuropsychiatric disorders, amyotrophy or cataracts [5], [6], [7]. Due to a high relapse rate affecting up to 40% of patients and given the tolerance issue of GC, the early introduction of immunosuppressive agents is more frequently practiced [2,[8], [9], [10], [11], [12]]. Tocilizumab (TCZ) and methotrexate (MTX) are currently the two recommended first-line drugs for GCA [4]. Tocilizumab, an anti-interleukin 6 receptor, has been used since 2017 after the results of the GiACTA trial showed a good GC-sparing effect [13,14].

Conversely, data on MTX efficiency in the prevention of relapse and as a GC-sparing agent are rare, and available data reveal some controversial issues [15], [16], [17], [18], [19], [20]. Although MTX has been used in the treatment of GCA since the 1990s [21], three prospective studies in the early 2000s analyzed the efficiency of MTX in GCA and reported contradictory results [[16], [17], [18],22]. Mahr et al. [15] gathered data from three randomized placebo-controlled trials in a meta-analysis and showed a modest beneficial effect on the relapse rate and a slight reduction in GC cumulative doses. However, the external validity of these studies remains questionable given that the patients included were selected and the management of GC or MTX was not a good reflection of real-life practices [23]. Consequently, reports of real-life experiences of MTX in GCA are required to better determine the role of this treatment, which remains cost-effective and relatively well tolerated.

In this study, we aimed to determine the indications, efficiency and tolerance profiles of MTX in patients with GCA in a real-life setting. Given that the GC-sparing effect is currently one of the main objectives of the adjunction of an immunosuppressant in GCA, we particularly analyzed how GC administration evolved after MTX introduction.

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