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Abstract Number: 2739

Systemic Vasculitis: Incidence of Glucocorticoid Related Adverse Events

Luciano Fernando Lo Giudice1, Marina Scolnik2, Jose Maximiliano Martinez P3, Aurelia Luissi1, Valeria Scaglioni2 and Enrique R Soriano2, 1Rheumatology Unit, Internal Medicine Service, Hospital Italiano de Buenos Aires, Capital Federal, Argentina, 2Rheumatology Unit, Internal Medicine Service. Hospital Italiano Buenos Aires. Argentina, Buenos Aires, Argentina, 3Rheumatology, Internal Medicine Service, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Adverse events, ANCA, giant cell arteritis, glucocorticoids and systemic vasculitides

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Session Information

Date: Tuesday, October 23, 2018

Title: Vasculitis – ANCA-Associated Poster II

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: The glucocorticoid toxicity index (GTI) (Miloslavsky et al. Ann Rheum Dis 2017) is useful to assess impact on morbility associated with these drugs. It consists on two components, a compound and a specific index. This last includes serious clinical adverse effects.

Our objective was to assess the incidence of the items included in the specific index of the GTI in patients with Giant Cell Arteritis (GCA), Granulomatosis with Polyangeitis (GPA) and Microscopic Polyangiitis (MPA).

Methods: Clinical records of incident cases of GCA, GPA, MPA were scanned for serious adverse effects associated with GC treatment defined in the specific index of GTI over the first two years of treatment. The GC cumulative dose was calculated at 6 months, 1 year, and 2 years of treatment.

Incidence density of serious adverse effects was compared in patients with GCA (all fulfilling ACR criteria) and ANCA associated vasculitis (GPA and MPA, all fulfilling Chapel Hill criteria). Logistic regression multivariate analysis was performed to evaluate the association between total cumulative GC dose and severe adverse effects, adjusted by confounders.

Results: 130 patients were included (92 ACG, 18 GPA, 20 MPA), 80% of whom were women, with a median age at diagnosis of 77 years (ICR 72-81).

Cumulative GC doses at 6 months, 1 and 2 years of treatment were significantly higher in ANCA vasculitis.

97,4 % (IC 95% 82,9-99,6) of patients with ANCA vasculitis used inmunosupresors associated with GC at treatment start vs 14,1% (IC 95 8,3-22,9) of patients with GCA (p<0,001). Inmunosupresors usage in patients with GCA did not conduct to a lower cumulative GC dose at 2 years of treatment. 15 patients with ANCA vasculitis (39,5%, IC 95%: 25,1-55,9) and 36 with GCA (39,1%, IC 95%29,6-49,6) presented some serious adverse effect included in the GTI (p=0,97).

The adverse effect incidence density was 22,2/100 patients-year for ANCA and 19,9/100 patients-year for GCA (p=0,73). Severe infections were more frequent in patients with ANCA vasculitis than in GCA [13,2% (IC 95%: 5,4-28,4) vs 2,2% (IC 95%: 0,5-8,4), p=0,01]. Mortality was 28,9 % (IC 95%: 16,6-45,5) for ANCA vasculitis vs 3,3% (IC 95%: 1-9,8) for GCA (p<0,001). Having a severe adverse effect or a serious infection was not associated with the GC cumulative dose, the initial GC dose, GC pulses, cyclophosphamide use, and diagnosis in the multivariate analysis. The greater cumulative GC dose was associated with having ANCA vasculitis diagnosis (p=0,019) and having received GC pulses (p<0,001) in the linear regression analysis.

Conclusion: Incidence of GC related adverse effects at 2 years of treatment was similar in ANCA associated vasculitis and GCA. Presenting a serious adverse effect was not associated with the total cumulative or initial GC dose, or having received GC pulses. Serious infection rate was greater in ANCA vasculitis with no relation to the GC dose.

GCA

(n=92 )

GPA and MPA

(n=38 )

p

Age, years, median (RIC)

77 (73-80)

75 (65-82)

0,15

Female sex, % (IC95)

81,5 (72,1-88,3)

76,3 (59,9-87,4)

0,5

Follow up time, years, median (ICR)

12,4 (8,3-15,2)

10 (7,4-12,9)

0,08

Initial meprednisone oral dose, mg/day, median (ICR)

40 (30-40)

40 (40-60)

0,07

GC pulses, %, (IC 95%)

18,5 (11,7-27,9)

78,9 (62,8-89,3)

<0,001

Cumulative meprednisone dose, mg, median (RIC):

  • At 6 months

5010 (3660-6315)

6952(5280-8730)

<0,001

  • At 1 year

6510 (5040-8325)

7790 (6975-9930)

0,01

  • At 2 years

7440 (6240-10260)

9482 (8025-11200)

0,02

Initial associated Inmunosupresor at baseline, % (IC 95%)

14,1 (8,3-22,9)

97,4 (82,9-99,6)

<0,001

Severe GC related adverse effects, % (IC 95%):

Hypertensive emergency

0 (0)

2,6 (0,3-17,1)

0,12

Reversible posterior encephalopathy

0

0

—

Pathological fractures/avascular osteonecrosis

5,43 (2,3-12,5)

0

0,14

Severe reduction in BMD

9,9 (5,2-18,1)

2,6 (0,3-17,1)

0,16

Diabetic retinopathy /Diabetic Neuropathy/Diabetic Nephropathy

0

0

—

Severe cutaneous toxicity

0

0

—

Severe Myopathy

1,1 (0,1-7,5)

0

0,52

Psychosis

2,2 (0,5-8,4)

2,6 (0,3-17,1)

0,87

Severe Infection

2,2 (0,5-8,4)

13,2 (5,4-28,4)

0,01

Adrenal Insufficiency

1,1 (0,1-7,5)

0

0,52

Gastrointestinal Perforation

0

0

—

Gastrointestinal ulcers

0

0

—

Tendon ruptures

0

0

—

Cataracts

21,7 (14,4-31,5)

23,7 (12,6-40)

0,81

Retinopathy

1,1 (0,1-7,5)

0

0,52

Glaucoma

2,2 (0,5-8,4)

0

0,36

Obesity

1,1 (0,1-7,5)

5,3 (1,3-19,3)

0,15

Some severe adverse effect, % (IC 95%)

39,1 (29,6-49,6)

39,5 (25,1-55,9)

0,97

Mortality, % (IC 95%)

3,3 (1-9,8)

28,9 (16,6-45,5)

<0,001

Severe adverse effect incidence density at 2 years, in 100 person-year

19,9

22,2

0,73


Disclosure: L. F. Lo Giudice, None; M. Scolnik, None; J. M. Martinez P, None; A. Luissi, None; V. Scaglioni, None; E. R. Soriano, AbbVie, Bristol-Myers Squibb, GSK, Janssen, Novartis, Pfizer Inc, Roche, UCB, 2,AbbVie, Bristol-Myers Squibb, Eli Lilly, GSK, Janssen, Novartis, Pfizer Inc, Roche, Sanofi, UCB, 5,AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sandoz, UCB, 8.

To cite this abstract in AMA style:

Lo Giudice LF, Scolnik M, Martinez P JM, Luissi A, Scaglioni V, Soriano ER. Systemic Vasculitis: Incidence of Glucocorticoid Related Adverse Events [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/systemic-vasculitis-incidence-of-glucocorticoid-related-adverse-events/. Accessed .
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