A multicenter, randomized, double‐blind, placebo‐controlled trial of adjuvant methotrexate treatment for giant cell arteritis

Abstract

Objective. To evaluate treatment with methotrexate (MTX) in patients with newly diagnosed giant cell arteritis (GCA) to determine if MTX reduces GCA relapses and cumulative corticosteroid (CS) requirements and diminishes disease-and treatment-related morbidity.Methods. This was a multicenter, randomized, double-blind study. Over 4 years, 16 centers from the International Network for the Study of Systemic Vasculitides enrolled patients with unequivocal GCA. The initial treatment was 1 mg/kg/day (<60 mg every day) prednisone, plus either 0.15 mg/kg/week MTX (increased to 0.25 mg/kg/week, for a maximum weekly dosage of 15 mg) or placebo. Two physicians, both blinded to treatment allocation, evaluated each patient at every trial visit. One physician was responsible for providing global medical care. The other assessed GCA status according to a standard protocol. Treatment

Clinical Findings and Management of Giant Cell Arteritis

“…This mechanism accounts for the fact that the majority of patients affected by GCA are all over the age of 50, which is a population that tends to have arteriosclerotic disease of varying degrees [1][2][3][4][5][6][7][8][9][10]16,20,21]. Polymyalgia rheumatica is the only strongly associated systemic condition with giant cell arteritis; this condition tends to affect the joints and muscles in the neck, spine, and pelvic region which manifests as stiffness and pain.…”

“…50 percent of patients who have GCA are also symptomatic for polymyalgia rheumatica. Unfortunately, there are no specific tests for polymyalgia rheumatica, so there is little predictive value to be given to this particular condition, unless a patient comes in with this particular diagnosis, which is a diagnosis of exclusion [20,21]. There are no other systemic conditions strongly associated with giant cell arteritis.…”

“…For patients who manifest more ocular symptoms than systemic, fluorescein angiography can be used to assist in diagnosis. With an FA there is usually prolonged choroidal and arterial filling times, which often show areas of non-perfusion or defects in filling [1][2][3][4][5][6][7][8][9][10]21].…”

“…Also, GCA tends to have ischemic lesions somewhere in the retina, including central retinal artery occlusions, cilioretinal artery occlusions, or cotton-wool spots [15][16]26]. Additionally, patients with giant cell tend to report amaurosis fugax, and may be the only symptom that the patient reports [1][2][3][4][5][6][7][8][10][11][12][13][20][21][22][23][24][25][26]. As previously mentioned, fluorescein angiography can also be used to differentiate giant cell from any other ocular causes of vision loss, based on the filling pattern and the defects in filling that will be seen.…”

“…If GCA is suspected in a patient, same day erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) blood tests should be performed and high dose corticosteroids should be prescribed for the patient, even before a temporal artery biopsy is performed. The idea behind the high dose corticosteroids is to reduce the systemic inflammation and essentially "protect" the eye that still has vision remaining [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][18][19][20][21][22]. elicited in office when the area was palpated.…”