Background/Purpose: Several Clinical trials indicate that Methotrexate (MTX) could be considered as a feasible option in addition to corticosteroids for patients with GCA, but there is a need to corroborate these results in clinical practice. We want to assess the risk of relapses in GCA patients treated with MTX (since and after the diagnosis) and without MTX. Other factors associated were also investigated.

Methods: An inception cohort of GCA was assembled. We included patients from the date of diagnosis (January 1991 until September 2013) and followed-up in the out-patient clinic at Hospital Clinico San Carlos until September 2014. Main outcome: relapses defined as after an objective improvement (absence of symptoms of GCA and normalization of laboratory values) patient had again presence of symptoms or signs of GCA with high ESR and the need to increase corticosteroids at least 7.5mg. The independent variable was exposure to MTX (no exposure, exposure in the first month from the time of diagnosis, and exposure after). Covariables: 1) Sociodemographic, 2) Clinical symptoms and analytical data at diagnosis 3) Treatment: including concomitant corticoids, aspirin 4) Calendar time. Incidence rates of relapses (IR) per 100 patient-years with their respective 95% confidence interval [CI] were estimated using survival techniques. The time of exposure comprised the period from diagnosis until the occurrence of any of the following cut off points: lost of follow-up, main outcome, exposure to MTX or the end of the study. MTX influence on IR was analyzed by multivariable Cox models.

Results were expressed as hazard ratio (HR) and [CI]. Results: We included 168 patients (675 patient-years). Most of the patients were female (80%), with a mean age of 76±7 years. The mean dose of corticoids at starting was 55±15 mg/day. 65% of the patients were on MTX, and 45% of them started in the first month after the diagnosis. The mean dose was 10mg / week, being the maximum dose 20mg / week. 32.7% of patients (n=55) had 93 relapses during follow-up with an IR of 20.8[15.8-27.4]. The median [p25-75] number of relapses was 1[1-2], with a median lag time of 1.8 [0.6-5.8] years. In the multivariate analysis, after adjusting by age, gender, corticoids and calendar time, exposure to MTX in the first month had less risk of relapses compared to non exposed (HR: 0.44[0.2-0.9], p=0.02), whereas exposure to MTX after the first month of diagnosis (p=0.6) did not achieve statistical significance. Other variables in the model were: clinical debut with headache (HR: 4.6 [1.6-13.5], p=0.004), and visual alterations (HR: 2.3 [1.3-4.1], p=0.004). Taking aspirin during the follow- up (HR: 0.6 [0.3-1.1], p=0.1), and haemoglobin value (HR: 0.8 [0.7-1.0], p=0.1) did not achieve signification.

Conclusion:  Early use of MTX seems to decrease the risk of recurrences. The treatment with aspirin involves a tendency to lower risk of relapses. We have also found other factors that can influence on the risk of recurrences.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/treatment-with-methotrexate-and-risk-of-relapses-in-patients-with-giant-cell-arteritis-in-clinical-practice/