Table 1: Critical trial definitions.

TermDefinition

Revised GCA diagnosis criteria (1) Age ≥50 years
(2) History of ESR ≥50 mm/hour
(3) And at least one of the following:
 (a) Unequivocal cranial symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication)
 (b) Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory stiffness
(4) And at least one of the following:
 (a) Temporal artery biopsy revealing features of GCA
 (b) Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as magnetic resonance angiography (MRA), computed tomography angiography (CTA), or positron emission tomography-computed tomography (PET-CT)

New onset GCADiagnosis of GCA made within 6 weeks of baseline visit

Relapsing/refractory GCADiagnosis of GCA >6 weeks of baseline visit and active disease within 6 weeks of baseline visit

Active GCA(1) At least one of the following within 6 weeks of baseline visit
 (a) Unequivocal cranial symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication)
 (b) Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory stiffness
 (c) Other features judged by the clinician investigator to be consistent with GCA or PMR flares (i.e., new or worsened extremity claudication, fever of unknown origin)
(2) And ESR ≥30 mm/hr or CRP ≥1 mg/dL

RemissionAbsence of all symptoms attributable to active GCA and normalization of ESR (<30 mm/hr) and CRP (<1 mg/dL)

FlareRecurrence of symptoms attributable to active GCA, with or without elevation of ESR and/or CRP

Sustained remission (SR)(1) Absence of flare following remission by week 12 after randomization
(2) And completion of the assigned prednisone taper
(3) And not having required escape therapy at any time by week 52.