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Abstract Number: 2971

Rituximab Associated Hypogammaglobulinemia in Autoimmune Disease: Long Term Outcomes

Joanna Tieu1,2, Seerapani Gopaluni3,4, Rona Smith1 and David Jayne1, 1Department of Medicine, University of Cambridge, Cambridge, United Kingdom, 2Department of Medicine, University of Adelaide, Adelaide, Australia, 3Medicine, University of Cambridge, Cambridge, United Kingdom, 4Vasculitis and Lupus, Addenbrooke’s Hospital, Cambridge, United Kingdom

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: ANCA, complications and rituximab, SLE

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Session Information

Date: Wednesday, October 24, 2018

Title: 6W021 ACR Abstract: Misc Rheumatic & Inflam DZ II (2970–2975)

Session Type: ACR Concurrent Abstract Session

Session Time: 11:00AM-12:30PM

Background/Purpose:

Despite a low incidence of hypogammaglobulinemia (HG) in clinical trials using rituximab (RTX), HG occurs in follow-up of patients with autoimmune disease.

Immunoglobulin replacement therapy (IRT) has been used to reduce infection rates but there is a paucity of data on its efficacy and impact on longer-term outcomes.

We examined the characteristics of patients with RTX associated HG in autoimmune disease, and their long-term outcomes with and without IRT.

Methods:

Patients attending a Vasculitis and Lupus clinic, who received RTX for autoimmune disease between 2004 and 2012, with an immunoglobulin G (IgG) <7 g/L on at least 2 occasions were included in this retrospective case note review. Patients were categorized into nadir IgG subgroups of <3 g/L, 3 to <5 g/L and 5 to <7 g/L. Categorical variables are summarised as proportions, and continuous variables as mean ± standard deviation or median [interquartile range (IQR)]. Differences between nadir IgG subgroups were assessed by Chi squared tests and trends across subgroups confirmed by Somer’s D tests. Continuous variables were compared using analysis of variance (ANOVA), Kruskall-Wallis and Wilcoxon sign ranked tests as appropriate. Analyses were performed in SPSS.

Results:

Of 142 patients, 101 (71.1%) had ANCA associated vasculitis, 18 (12.7%) systemic lupus erythematosus and 23 (16.2%) other diagnoses. Most received RTX for relapsing (69.3%) or refractory (25.0%) disease. Mean follow-up was 97.2 months from first RTX.

Progressive HG was observed. Median time to IgG <5 g/L was 22.5 months [IQR 3.0 to 61.5] and to IgG <3 g/L was 24.5 months [IQR 4.0 to 80.75].

Mycophenolate use prior to RTX and prednisolone use following RTX were associated with a lower nadir of IgG (Table 1). These associations were confirmed by Somer’s D tests.

IRT was commenced in 29 patients, the majority (65.5%) with IgG <3 g/L. It was well tolerated, with 2 discontinuing due to adverse effects. IRT was withdrawn without excess recurrent infections in 5 patients.

IRT was associated with a reduction in annual infection rates (Table 2). Severe infections (requiring intravenous antibiotics or hospital admission) were uncommon, with no change with the use of IRT.

Conclusion:

RTX associated HG is progressively identified with longer term follow-up. Although annual infection rates were low, in patients with recurrent infection, use of IRT was associated with a reduction in infection burden.

 

Table 1

 

 

 All

 (n = 142)

 nadir IgG 5 – 7 g/L

 (n = 40)

 nadir IgG 3 – 5 g/L

 (n = 66)

 nadir IgG < 3 g/L

 (n = 36)

 p

 

Pre-RTX immunosuppression

 Cyclophosphamide

 107/142 (75.4)

 29/40 (75.0)

 49/66 (74.2)

 28/36 (77.8)

0.92

 cum CYC

 12.0 [6.0 – 26.0]

 12.0 [5.8 – 27.8]

 11.5 [6.0 – 17.3]

 11.0 [5.7 – 27.0]

0.91

 Azathioprine

 88/141 (62.4)

 27/40 (67.5)

 39/65 (60.0)

 22/36 (61.1)

0.73

 Mycophenolate

 94/141 (66.7)

 25/40 (62.5)

 39/65 (60.0)

 30/36 (83.3)

0.05*

 Methotrexate

 36/141 (25.5)

 10/40 (25.0)

 20/65 (30.8)

 6/36 (16.7)

0.30

 PLEX

 16/141 (11.3)

 4/40 (10.0)

 5/65 (7.7)

 7/36 (19.4)

0.19

 Number of prior IS medications

 2.9 ± 1.7

 2.9 ± 1.3

 2.8 ± 1.8

 3.2 ± 1.7

0.57

 

 Cumulative RTX

 9.0 ± 5.1

 8.5 ± 4.7

 9.8 ± 5.6

 8.1 ± 4.4

0.23

 

 Glucocorticoid use (prednisolone)

 Baseline

 115/121 (95.0)

 36/38 (94.7)

 53/55 (96.4)

 26/28 (92.9)

0.78

 6 months

 120/133 (90.2)

 31/39 (79.5)

 61/63 (96.8)

 28/31 (90.3)

0.02

 12 months

 113/137 (82.5)

 27/39 (69.2)

 56/64 (87.5)

 30/34 (88.2)

0.04*

 24 months

 98/133 (73.7)

 22/37 (59.5)

 48/62 (77.4)

 28/34 (82.4)

0.06*

 

CYC: cyclophosphamide, PLEX: plasma exchange, IS: immunosuppressive

mean ± standard deviation, median [IQR], proportion (%)

Chi squared test p-values presented for proportions; * Somer’s D test p-value ≤0.05

Table 2

 

 

 All

 (n = 142)

 nadir IgG 5 – 7 g/L

 (n = 40)

 nadir IgG 3 – 5 g/L

 (n = 66)

 nadir IgG < 3 g/L

 (n = 36)

 p

 

 No IRT

 113/142 (79.6)

 39/40 (97.5)

 57/66 (86.4)

 17/36 (47.2)

<0.001*

 Infections/yr

 0.44 [0.15 – 0.99]

 0.38 [0.14 – 0.94]

 0.48 [0.15 – 1.04]

 0.50 [0.00 – 1.12]

0.34

 Severe inf/yr

 0.00 [0.00 – 0.24]

 0.12 [0.00 – 0.24]

 0.00 [0.00 – 0.26]

 0.00 [0.00 – 0.09]

0.39

 

 IRT

 29/142 (20.4)

 1/40 (2.5)

 9/66 (13.6)

 19/36 (52.8)

<0.001*

 Infections/yr (no IRT)

 1.02 [0.54 – 1.88]

 2.49

 1.02 [0.57 – 1.98]

 0.89 [0.44 – 1.85]

–

 Infections/yr (IRT)

 0.13 [0.00 – 0.35]

 

 

 

<0.001 α

 Severe inf/yr (no IRT)

 0.19 [0.00 – 0.45]

 1.17

 0.28 [0.00 – 0.66]

 0.07 [0.00 – 0.41]

–

 Severe inf/yr (IRT)

 0.00 [0.00 – 0.89]

 

 

 

0.97 α

 

median [IQR], proportion (%)

α IRT vs no IRT; Wilcoxon sign ranked tests

Chi squared test p-values presented for proportions; * Somer’s D test p-value ≤0.05

 


Disclosure: J. Tieu, Roche, 2; S. Gopaluni, None; R. Smith, None; D. Jayne, Chemocentryx, GlaxoSmithKline, Sanofi, Roche, 2,Boehringer-Ingelheim, Astra-Zeneca, AbbVie, CSL, InflaRx, Bristol-Myers Squibb, Takeda, 5,Aurinia, 6.

To cite this abstract in AMA style:

Tieu J, Gopaluni S, Smith R, Jayne D. Rituximab Associated Hypogammaglobulinemia in Autoimmune Disease: Long Term Outcomes [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/rituximab-associated-hypogammaglobulinemia-in-autoimmune-disease-long-term-outcomes/. Accessed .
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