Health-Related Quality of Life in Patients With Giant Cell Arteritis Treated With Tocilizumab in a Phase 3 Randomised Controlled Trial

Vibeke Strand; Sophie Dimonaco; Katie Tuckwell; Micki Klearman; Neil Collinson; John H. Stone

Disclosures

Arthritis Res Ther. 2019;21(64) 

In This Article

Background

Giant cell arteritis (GCA) is a systemic vasculitis that primarily affects medium- to large-sized arteries including the aorta, its primary branches, and vessels supplying the eyes and brain. The prevalence of GCA in the general population ranges from 0.01 to 0.25%,[1–4] and it is estimated that this disease will be diagnosed in more than 3 million people in Europe, North America and Oceania by 2050.[5] Glucocorticoid therapy, regarded for decades as the standard of care for GCA, is associated with a legion of potentially serious adverse effects and is often poorly tolerated.[6] Although it is generally recommended that glucocorticoid doses be tapered as rapidly as possible, many patients with GCA require unacceptably high doses over the long-term to control their symptoms and to prevent disease complications.[7–9]

Health-related quality of life (HRQOL) has not been investigated extensively in patients with GCA and has not been reported in patients with GCA receiving treatment in a randomised controlled trial (RCT). Complications of GCA and adverse effects of long-term glucocorticoid treatment can result in physical and psychological problems that have the potential to impair HRQOL in patients with GCA.[10] However, reports on HRQOL assessment in patients with GCA are limited. Fears surrounding potential vision loss and dissatisfaction with the adverse effects of glucocorticoids were identified as the most important HRQOL concerns in a survey of patients with GCA,[11] but vision loss was not associated with impaired HRQOL at baseline or after treatment with glucocorticoids with or without methotrexate in an RCT that enrolled too few patients for a treatment effect to be investigated.[12] In a case-control study, HRQOL was not impaired in patients with GCA either before or after glucocorticoid treatment compared with controls,[13] though this study examined only HRQOL data after high-dose glucocorticoid treatment had been discontinued (the 30 patients in the analysis had either stopped corticosteroid treatment or were taking long-term low doses of glucocorticoids).

GiACTA was a 52-week phase 3 RCT that led to the approval of tocilizumab (TCZ) for the treatment of GCA in the USA,[14] the European Union[15] and other countries. We report here patient-reported outcomes (PROs) from this trial, including comparison between the treatment groups for 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) scores and domains, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue and Patient Global Assessment of Disease Activity (PtGA). We also compare reported improvements at 52 weeks among treatment groups that are greater than minimum clinically important differences (MCIDs) or age- and gender-matched normative values (A/G norms). This is the first time that HRQOL has been reported in patients with GCA treated in an RCT, and, as such, the findings provide important information on QOL improvements in patients treated with TCZ and tapered glucocorticoids.

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