ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1769

Efficacy and Safety of Biomimic Rituximab in Granulomatosis with Polyangiitis – Experience from a Single Tertiary Care Centre in India

Aman Sharma1, Sakshi Mittal2, GSRSNK Naidu3, Saket Jha2, Manish Rathi4, Vikas Sharma2, Arghya Chattopadhyay5, Varun Dhir6, Kusum Sharma7, Ranjana Minz8, Ritambhra Nada9 and Sanjay Jain10, 1Clinical Immunology and Rheumatology Services, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India, Chandigarh, India, 2Internal Medicine, PGIMER, Chandigarh, India, 3PGIMER, cHANDIGARH, India, 4Department of Nephrology,, Postgraduate Institute of Medical Education and Research, Chandigarh, India, 5PGIMER, Chandigarh, India, 6Internal Medicine (Rheumatology Unit), Postgraduate Institute of Medical Education and Research, Chandigarh, India, Chandigarh, India, 7Department of Medical Microbiology,, PGIMER,, Chandigarh, India, 8Department of Immunopathology,, PGIMER,, Chandigarh, India, 9Postgraduate Institute of Medical Education and Research, Chandigarh, India, 10Postgraduate Institute of Medical Education and Research, Chandigarh, India, CHANDIGARH, India

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: , ,

Session Information

Date: Monday, October 22, 2018

Title: Vasculitis – ANCA-Associated Poster I

Session Type: ACR Poster Session B

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

Background/Purpose: Though rituximab(RTX) has become a standard of care for remission induction and maintenance in Granulomatosis with Polyangiitis(GPA), there is very limited data on the efficacy and safety of biomimic RTX in GPA. The purpose of this study was to analyse the efficacy and safety of biomimic RTX in GPA since these drugs are widely used in various developing countries due to their lower costs.

Methods:

The details of GPA patients diagnosed according to the ACR/EMA criteria who received biomimic RTX from July 2009 to May 2018 for remission induction or maintenance were analysed retrospectively. Patients achieving complete remission (BVAS-v3 =0) at 6, 12 and 24 months was noted. The details of relapses, infections and deaths were also noted.

Results:

Out of 184 GPA patients seen during the study period, 56 (30.43%) received biomimic RTX. The baseline characteristics of the study population are given in table 1. Forty five patients (80.36%) received biomimic RTX for remission induction (primary induction in 20 and re-induction in 25) and 43(76.79%) received biomimic RTX maintenance. Mean BVAS-v3 at the start of induction with biomimic RTX was 14.63 (SD 10.37).Complete remission at 6,12 and 24 months was achieved in 71.43%, 71.43% and 85.71% respectively. Mean BVAS-v3 at 6 , 12 and 24 months was 1.22 (SD 2.46), 1.02 (SD 2.28) and 0.45 (SD 0.98) respectively. Fifteen relapses were noted in 13 patients. Average time to first relapse was 10.15 months. 18 episodes of infections were noted in 17 patients (30.36%). The infections noted were UTI in four; sepsis in three; hepatitis C and superficial mycosis in two patients each; pulmonary tuberculosis, bacterial pneumonia, lung abscess, aspergilloma, H1N1 influenza, pyomyositis and bacterial nasal septal abscess in one patient each. Mean duration of follow up on biomimic RTX therapy was 23.66 months (SD 18.25). Seven patients (12.5%) died during follow up. The cause of death was disease activity in four and sepsis in three patients. Of the four patients who died due to disease activity, three died at the time of presentation and the fourth died within two months of biomimic RTX initiation.

Conclusion: Biomimic RTX is effective in controlling disease activity in patients with GPA. Infections though common were treatable in most of the patients.

Table 1: Characteristics of 56 GPA patients receiving biomimic rituximab

Characteristics

Numbers

Percentage (%)

Number of GPA patients

184

No. of patients receiving biomimic rituximab

56

30.43

Age

40.48(SD15.99)

–

Male

Female

22

34

39.28

60.71

Clinical Features

Constitutional

Upper Respiratory Tract

Eye

Ear

Lung

Renal

Skin

Joint

Peripheral nervous system

Central nervous system

Gastro-intestinal

Cardiac

36

39

20

16

39

19

16

25

5

16

9

4

64.29

69.64

35.71

28.57

69.64

33.93

28.57

44.64

08.93

28.57

16.07

07.14

PR3 positive

MPO positive

cANCA positive

pANCA positive

37

2

40

3

66.07

03.57

71.43

05.36

Patients receiving rituximab induction

Primary induction

Re-induction

45

20

25

80.36

35.71

44.64

Patients on rituximab maintenance

43

76.79

Mean duration of follow up (months)

23.66(SD18.25)

–

Mean BVAS at the time of induction with Rituximab

14.63(SD10.37)

–

Mean BVAS at 6 months

1.22(SD2.46)

–

Mean BVAS at 1 year

1.02(SD2.28)

–

Mean BVAS at 2 years

0.45(SD0.98)

Number of relapses

15

26.78

Mean time to first relapse (months)

10.15 (SD6.94)

–

Number of infectious complications

18

32.14

Deaths

7

12.50

Disclosure: A. Sharma, None; S. Mittal, None; G. Naidu, None; S. Jha, None; M. Rathi, None; V. Sharma, None; A. Chattopadhyay, None; V. Dhir, None; K. Sharma, None; R. Minz, None; R. Nada, None; S. Jain, None.

To cite this abstract in AMA style:

Sharma A, Mittal S, Naidu G, Jha S, Rathi M, Sharma V, Chattopadhyay A, Dhir V, Sharma K, Minz R, Nada R, Jain S. Efficacy and Safety of Biomimic Rituximab in Granulomatosis with Polyangiitis – Experience from a Single Tertiary Care Centre in India [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/efficacy-and-safety-of-biomimic-rituximab-in-granulomatosis-with-polyangiitis-experience-from-a-single-tertiary-care-centre-in-india/. Accessed .

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