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Abstract Number: 751

Rituximab Induced Serum Sickness: A Systematic Review

Paras Karmacharya1, Dilli Poudel1, Ranjan Pathak1, Anthony Donato2, Sushil Ghimire1, Smith Giri3, Madan Aryal1 and Clifton O. Bingham III4, 1Internal Medicine, Reading Health System, WEST READING, PA, 2Internal medicine, Reading Health System, WEST READING, PA, 3Internal medicine, University of Tennessee Health Science Center, Memphis, TN, 4Rheumatology, Johns Hopkins University, Baltimore, MD

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: immunology, infusions, rheumatoid arthritis (RA) and rituximab

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Session Information

Date: Sunday, November 8, 2015

Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment Poster Session I

Session Type: ACR Poster Session A

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

Background/Purpose: Rituximab (anti-CD20 monoclonal antibody) has been frequently used to treat various autoimmune diseases in which B-cells are participants, and for hematological malignancies in which CD20-bearing cells are increased. Infusion reactions including fever, chills and rigors, as well as allergic (Type IV) anaphylactoidspectrum reactions and less commonly serum sickness (or Type III) hypersensitivity reaction have been reported with its administration. It is important to recognize this as re-exposure can result in recurrent and more severe manifestations. We perform a systematic review and meta-analysis to characterize RISS in autoimmune diseases and hematological malignancies.

Methods: A comprehensive search of MEDLINE, EMBASE, ACR and EULAR databases was performed for relevant articles of patients with RISS from inception to September 2014 (Figure 1). Statistical analysis of demographic and clinical features was performed using Microsoft EXCEL 2007 and SPSS version 20.0.

Results: In the 33 patients (from 25 reports) with RISS, the mean age of presentation was 39.1±17.5 years with a female preponderance (n=23, 76.67%). The majority of cases were associated with an underlying autoimmune condition (n=28, 84.85%), most commonly immune thrombocytopenic purpura (n=10) and Sjögren’ssyndrome (n=7 and lymphomas in 5/33 cases (15.15%) (Table 1). Symptoms of RISS began 6.63±3.83 days following infusion with most episodes occurring during the first cycle. Classic triad of serum sickness (fever, rash and arthralgia) was reported in 16 (48.5%) cases. Time from drug exposure to symptom onset was significantly greater with the first doses of rituximab compared to the second dose (mean time 10.00 vs. 4.05 days, P=0.002), and time to resolution was significantly greater for rheumatologic vs. hematological indications (mean time 2.50 vs 1.00 days, P=0.035). Corticosteroids were the most commonly used treatment (n=21), with all cases reporting a complete resolution of symptoms in 2.15±1.34 days.

Conclusion: It is important to recognize and diagnose RISS clinically as it may mimic exacerbation of various rheumatologic conditions such as RA. Although elevated RF, immunoglobulins and HACA levels may play a role in the pathogenesis, these are not predictable markers, as the serologic and Ig levels are features of the underlying disease. RISS is often a benign condition with prompt and complete resolution with corticosteroids. That some patients have experienced recurrent RISS with re-exposure indicates that providers should carefully weigh risks and benefits of continuing or reintroducing rituximab.

SN

Author, Year

Study Design

Condition

Age/Sex

Dosing Protocol (amount x doses)

Dose Causing SS (cycle number, dosing number in the cycle)

Onset of SS from Last Dose

H/O

Immediate Transfusion Reaction

Antibody Profile

Treatment for SS

Remarks

Autoimmune Diseases

1

D’Arcy et al.,2001

Case Study

Autoimmune Polyneuropathy

45/M

NA

1,NA

10

No

NA

IV MP pulse

–

2

Herishanu et al.,2002

Case Study

Refractory ITP

48/F

Mentioned as weekly dose

2,NA

6

No

ANA negative

IV MP 500mg x 2d

–

3

Hellerstedt et al.,2003

Case Study

SLE

23/F

NA

1,2

1

No

NA

IV Steroid bolus

–

4

Catuogno et al.,2005

Case Study

Cryoglobulinemia

60/F

375 mg/m2 x 4

1,1

7

No

RF positive (RA test, Fii latex, Waaler-Rose)

IV Betamethasone 4mg

–

5

Pijpe et al.,2005

Open-Label Phase II study

Sjӧgren’s Syndrome

41/F

375 mg/m2 x 4

1,2

5-7

No

RF (125 KIU/L); anti-SSA positive; anti-SSB positive; HACA positive

IV MP 1000mg

–

6

Pijpe et al.,2005

Open-Label Phase II study

Sjӧgren’s Syndrome

39/F

375 mg/m2 x 4

1,2

5-7

No

RF (16 KIU/L); anti-SSA positive; anti-SSB positive; HACA positive with 1.32% activity

IV MP 1000mg

–

7

Pijpe et al.,2005

Open-Label Phase II study

Sjӧgren’s Syndrome

27/F

375 mg/m2 x 4

1,2

5-7

No

RF (569 KIU/L); anti-SSA positive; HACA positive with <1% activity

NA

–

8

Wang et al.,2005

Prospective

Chronic ITP

14/F

375 mg/m2 x 4

1,2

7-14

No

NA

NA

–

9

Wang et al.,2005

Prospective

Chronic ITP

12/F

375 mg/m2 x 4

1,3

7-14

No

NA

NA

–

10

Wang et al.,2005

Prospective

Chronic ITP

12/F

375 mg/m2 x 4

1,1

NA

Yes

NA

NA

–

11

Bennett et al.,2006

Prospective

Chronic ITP

12/M

375 mg/m2 x 4

1,2

After second dose

No

NA

NA

–

12

Bennett et al.,2006

Prospective

Chronic ITP

11/F

375 mg/m2 x 4

1,2

After second dose

No

NA

NA

–

13

Schutgens et al.,2006

Case Study

Sjӧgren’s Syndrome

46/F

375 mg/m2 x 4

1,NA

2

No

NA

oral Prednisone 20 mg/d

MALT of right parotid gland

14

Devauchelle et al.,2007

Prospective

Sjӧgren’s Syndrome

NA

375 mg/m2 x 4

1,2

NA

No

NA

NA

–

15

Finger et al.,2007

Case Study

Polyclonal Hypergammaglobulinemia

45/F

NA

1,1

7

No

NA

IV HCT 125 QID x 3 days

Associated Sjӧgren’s Syndrome

16

Finger et al.,2007

Case Study

Polyclonal Hypergammaglobulinemia

38/F

1000 mg x 2

2,2

1

No

NA

IV HCT 125 QID x 3 days

–

17

Seror et al.,2007

Retrospective

Sjӧgren’s Syndrome

43/F

375 mg/m2 x 4

1,2

3

No

RF (499 IU/L); anti-SSA positive; anti-SSB positive; HACA (significant level)

None

Salivary Lymphoma (MALT)

18

Dass et al.,2008

Randomised, double-blind, placebo-controlled pilot study

Sjӧgren’s Syndrome

NA

1000 mg x 2

1,1

7

No

anti-SSA positive; anti-SSB (78% positive in treatment group)

IV steroid

–

19

Godeau et al.,2008

Prospective multicenter phase 2 study

Chronic ITP

NA

375 mg/m2 x 4

1,NA

NA

No

NA

NA

–

20

Medeot et al.,2008

Prospective Study

Relapsed or refractory ITP

NA

375 mg/m2 x 4

1,2

Soon after

No

NA

Steroid

–

21

Mehsen et al.,2008

MCTD

30/F

NA

1,1

13

No

NA

oral anti-Histaminics

–

22

Goto et al.,2009

Case Study

Chronic ITP

8/M

375 mg/m2 x 4

2,2

10

No

ANA (<40x); RF (0.30); anti-DNA (1 IU/ml); HACA (244 ng/ml)

Oral PDS 1.8 mg/kg/day x 1 mo;

–

23

Sène et al.,2009

Case Series

Cryoglobulinemia

47/M

1000 mg x 2

2,1

7

No

NA

NA

Hep C positive

24

Sène et al.,2009

Case Series

Cryoglobulinemia

53/F

1000 mg x 2

2,1

9

No

NA

NA

Hep C positive

25

Guenno et al.,2011

Case Study

Chronic ITP

31/F

375 mg/m2 x 4

1,1

13

No

RF negative

IV MP 120 mg x 1d then oral Steroid x 7d

–

26

Kumar et al.,2012

Case Study

RA

60/F

1000 mg x 2

2,1

6

Yes

RF (44.4 U/ml); anti-CCP (114 U/ml); ANA (negative)

IV MP 80mg x once; Levocetrizine

–

27

Sandhu et al.,2012

Case Study

Post kidney transplant rejection

52/M

NA

1,NA

14

No

ANA negative; RF negative; anti-CCP (0.5 Units/ml); anti-SSA (8 U/ml); anti-SSB (9 U/ml); anti-DNA (4 U/ml)

IV MP 500mg/d x 3d

Acute cellular and humoral rejection

28

Ungprasert et al.,2013

Case Study

Sjӧgren’s Syndrome and SLE

50/F

NA

2,1

7

No

NA

IV MP x 2d then oral Prednisone x 7d

–

Hematologic Diseases

29

Portlock et al., 2005

Prospective Phase 2 study

Lymphoma

51/F

375 mg/m2 x 4

2,1

7

No

HACA positive

Prednisone

Follicular lymphoma, previously treated

30

Portlock et al., 2005

Prospective Phase 2 study

Lymphoma

70/M

376 mg/m2 x 4

1,2

5

No

HACA negative

Prednisone

Follicular lymphoma, previously untreated

31

Todd et al., 2006

Case Study

Lymphoma

68/M

375 mg/m2 x 4

1,1

13

No

ANA normal; RF normal: anti-CCP normal; HACA negative

IA MP 80mg then oral Prednisone 20 mg/d tapered over 4 wks

Mantle cell, stage 2a

32

Disperati et al., 2007

Case Study

Lymphoma

52/F

180mg/m2 x 4

5,1

2

Yes; during prior two cycles

RF negative; ANA negative

IV MP, IV Diphenhydramine and IV Mepiridine

Stage IV follicular

33

DeMonaco et al., 2007

Case Study

Lymphoma

47/F

375 mg/m2 x 4

4,2

7

No

HAMA negative

Steroid x 10d

Follicular, grade 3 of 3


Disclosure: P. Karmacharya, None; D. Poudel, None; R. Pathak, None; A. Donato, None; S. Ghimire, None; S. Giri, None; M. Aryal, None; C. O. Bingham III, None.

To cite this abstract in AMA style:

Karmacharya P, Poudel D, Pathak R, Donato A, Ghimire S, Giri S, Aryal M, Bingham CO III. Rituximab Induced Serum Sickness: A Systematic Review [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/rituximab-induced-serum-sickness-a-systematic-review/. Accessed .
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