ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 050

Long Term Safety of Biologics and Biosimilars in Pediatric Rheumatic Diseases: An Experience from a Single North Indian Centre

MANJARI AGARWAL 1, Sujata Sawhney2 and Anju Singh 3, 1Sir Ganga Ram Hospital, NEW DELHI, Delhi, India, 2Sir ganga ram hospital, Sector 37 noida, Uttar Pradesh, India, 3Sir Ganga Ram Hospital, delhi, India

Meeting: 2020 Pediatric Rheumatology Symposium

Keywords: , , ,

Session Information

The 2020 Pediatric Rheumatology Symposium, originally scheduled for April 29 – May 2, was postponed due to COVID-19; therefore, abstracts were not presented as scheduled.

Date: Thursday, April 30, 2020

Title: Poster Session 1

Session Type: ACR Abstract Session

Session Time: 6:00PM-7:00PM

Background/Purpose:  The use of biologic response modifiers(BRMs) is associated with an increased risk of infections.

We also use biosimilars for two reasons:1. originator not available, like Adalimumab, or 2. prohibitive cost of originator molecule. 

This study was undertaken to

  1. Study the usage of BRMs at our centre
  2. Study the adverse events in biologics and biosimilars over a longitudinal follow up

Methods: All patients who received a BRM from 1st January 2006 to 31st December 2019 were included. The pre BRM screening, diagnosis along with adverse events, were retrospectively collected

Results: Demographics: Total 340 children received 417 BRMs. M:f:213:127

Median age at commencing first cycle of a BRM: 11.66 yrs(IQR 7.54-15.29)

Median duration of follow up:40months(IQR22-64)

Diagnosis: JIA(ERA:163,SJIA:65,PJIA:43,OJIA:23,UJIA:6,Psoriatic arthritis:1,Extended OJIA:2,) Uveitis:5,CTDs(SLE:23,Overlap syndrome:1)Vasculitis(Kawasaki disease:2, Takayasu’s aortoarteritis:3,Behcet’s disease:1)Others(IBD associated arthritis:1,MAGIC syndrome:1)

Screening protocol: Chest X ray, USG abdomen, Mantoux test, HIV and HbsAg were done for all. 
Table 1: Screening prior to biologics

         

Investigation

Normal

Abnormal

Not done

Chest X ray

398

12

7

USG abdomen

370

9

40

Mantoux test

379

31

5

Quantiferon Gold

279

33

Positive:12

Indeterminate:11

115

HIV

417

0

0

HbsAg

417

2

0

HCV

258

0

159

CECT thorax

136

17

264

CECT abdomen

34

4

379

Post biologic screening

Screening for Tuberculosis with Mantoux test,Chest Xray,USG abdomen repeated after one year of BRM exposure

Repeated

Not repeated

Asymptomatic mantoux conversion without active TB disease

No.

173

244

 

 16
       
Symptomatic tuberculosis disease 4 children( Post Infliximab-1, post Adalimumab-3)

        

50 adverse events were seen during long term follow as detailed in table 2

Drug ( No of patients )

Side effects

Total

Infliximab

N=61

Asymptomatic Mantoux conversion-6

Dengue fever-3

Tuberculosis disease-1

Varicella-1

Hepatitis A infection-2

13

Tocilizumab

N=74

Prolonged upper respiratory tract infections-4

Dengue fever-3

Pneumonia-1

Gram negative septicemia-1

Herpetic keratitis-1

H1N1 infection-1

Deaths-3

(one Dengue fever with Macrophage activation syndrome, one H1N1 infection, one GI infection with polymicrobial sepsis with macrophage activation syndrome)

14

Etanercept

N=87

Uveitis-3

Dengue fever-2

Varicella-2

Autoimmune hemolytic anemia-1

Asymptomatic mantoux conversion-4

Malaria-1

13

Biosimilar Etanercept

N=69

Skin cellulitis-2

Uveitis-4

6

Rituximab

N=30

Herpes zoster-2

Enteric fever-1

3

Biosimilar Adalimumab

N=84

Herpes zoster-1
disseminated tuberculosis- 2
Spongiform Psoriasis-1

4

Golimumab

N=10

Urinary  tract infection-1

1

Abatacept

N=2

No adverse event

0

417 BRMs

54

Conclusion:

  1. BRMs(both biologic and biosimilars) can be safely used for prolonged periods of time even in regions where there is a high background incidence of infections
  2. 54 adverse events occurred on exposure to a BRM in 417 episodes.99% recovered without sequelae.3/217 patients died(0.72% mortality)
  3. Annual screen for TB should be done to detect asymptomatic Mantoux conversion to prevent dissemination of disease  Asymptomatic Mantoux converters(n=16, 9.2% of tested patients)were picked up with this protocol.
Disclosure: M. AGARWAL, None; S. Sawhney, None; A. Singh, None.

To cite this abstract in AMA style:

AGARWAL M, Sawhney S, Singh A. Long Term Safety of Biologics and Biosimilars in Pediatric Rheumatic Diseases: An Experience from a Single North Indian Centre [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 4). https://acrabstracts.org/abstract/long-term-safety-of-biologics-and-biosimilars-in-pediatric-rheumatic-diseases-an-experience-from-a-single-north-indian-centre/. Accessed .

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