Background/Purpose:

Large vessels vasculitis (LVV) is the most common form of primary vasculitis comprising giant cell arteritis (GCA) and Takayasu arteritis (TAK) and aortitis.

Methods:

We collect retrospectively 21 patients affected by LVV, resistant to conventional therapy and treated with intravenous or subcutaneous biologics. Four patients were affected by GCA, with positive temporal artery biopsy; nine patients were affected by TAK according to 1990 ACR criteria and eight patients were affected by aortitis (two with associated retroperitoneal fibrosis), diagnosed with a positive 18F-FDG-PET scan, indicating active LVV with aortic involvement. Data from 18F-FDG PET and CT or MRI associated with improvement of clinical and inflammatory index (ESR and PCR) were used as a criteria of response to treatment. Our aim is to demonstrate the long term efficacy and safety of biologics in LVV.

Results:

The mean age of 21 patients were 57 year (18-87). Five patients were men with mean age of 65 year (32-79), 16 were women with mean age of 55.3 year (18-87).The mean follow-up time of patients was 29 months (2-79). Eighteen patients out of 21 (86%), suffered an aortic involvement at diagnosis discovered with 18F-FDG-PET scan. These patients were checked yearly with imaging using 18F-FDG-PET with a semiquantitative analysis. 18F-FDG-PET scan follow-up data were available in 12 patients. Tocilizumab (TCZ) was used in 19 patients for a medium period of follow-up period of 25 months (2-60). All patients started with EV TCZ (8 mg/kg/4w), then five patients passed to subcutaneous TCZ reducing the dose to 162 mg/2w. Seventeen patients demonstrated a good response with clinical improvement, reduction of inflammatory index and sparing of steroid dose. Two TAK patients experienced a failure treatment (new stenosis) one after one and the other after 4 year of treatment each. Infliximab was used in 3 patients and suspended in all three patients for infusive reactions, after three (one patient) and six month (2 patients) of treatment. Adalimumab (ADA) was used in 2 patients: one patient responded well with a negative PCR and a negative 18F-FDG-PET scan after one year of treatment and maintain stable remission without steroid, lasting 79 months; the other patient started the treatment three month ago. Golimumab 100 mg/m was used in one TAK patient, resistant to TCZ, with achieving a stable clinical and imaging remission (no new stenosis) during the last year. This patient refused steroid assumption. The side effects were bronchitis affecting two patients with TCZ and one patient with ADA and golimumab each. One patient with aortitis retroperitoneal fibrosis suspended TCZ after two infusions for acute cholecystitis. Mean steroid dose at the beginning of biologics treatment were 30 mg/day (50-0). Mean steroid dose at the last follow-up was 7 mg/day (32-0).

Conclusion:

In these group of 21 patients biological treatments demonstrated longterm efficacy and acceptable safety profile and important steroid sparing effect.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-efficacy-and-safety-of-intravenous-and-subcutaneous-biologics-in-large-vessels-vasculitis-21-patients-belonging-to-a-single-italian-center-from-2011-to-2017/