Session Information
Date: Thursday, May 18, 2017
Session Title: Clinical and Therapeutic Poster Session
Session Type: Abstract Submissions
Session Time: 5:30PM-7:00PM
Biologic Response modifiers (BRMs) are sparingly used in India due to: cost & concern of infections. We are a tertiary level centre & have used BRMs since 2006,with stringent screening. This study was undertaken to add to the knowledge about the use of BRMs in children with rheumatic ds. from an area of high burden of infections.
Aims
- To study the use of BRMs in pediatric rheumatic diseases at our centre.
- To evaluate the safety of BRMS over a longitudinal follow up of 10 yrs.
Methods: All patients who received a BRM from 1st January 2006 to 15th January 2017 were included. The pre BRM screening, demographic details, diagnosis along with adverse events, were retrospectively collected till last review.
Results:
Demographics: Total 217 children received 268 BRMs. Male:female:125:92.
Median age at disease onset:8.91yrs(0.25-17.83),median age at disease diagnosis:9.66yrs(0.75-18.08),median delay to diagnosis:5 mths(0.5-84).
Median age at commencing first cycle of a BRM:11.37yrs(3.4-27.66).Median duration of follow up:25.9mths(1-124)
Diagnosis:JIA(ERA:102,SOJIA:42,PJIA:22,OJIA:8,UJIA:2,Extended OJIA:1,) ChronicUveitis:12,CTDs(SLE:16,Overlap syndrome:1)Vasculitis(Kawasaki disease:4, Takayasu’s aortoarteritis:1,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. Quantiferon gold(Q gold) was done for all since 2011.Contrast CT of chest &abdomen were done if Mantoux and/or Q gold were positive.
Table 1:Screening
|
Investigation |
Normal |
Abnormal |
Not done |
|
Chest X ray |
215 |
2 |
0 |
|
USG abdomen |
216 |
1 |
0 |
|
Mantoux test |
201 |
16 |
0 |
|
Quantiferon Gold |
162 |
18 Positive:10 Indeterminate:8 |
37 |
|
HIV |
217 |
0 |
0 |
|
HbsAg |
216 |
1 |
0 |
|
HCV |
158 |
0 |
59 |
|
CECT thorax |
107 |
3 |
107 |
|
CECT abdomen |
19 |
4 |
194 |
|
Post biologic screening |
|||
|
Screening for Tuberculosis with Mantoux test,Chest Xray,USG abdomen repeated after one year of TNFi exposure |
Repeated |
Not repeated |
Asymptomatic mantoux conversion without active TB disease |
|
No. |
77 |
122 |
7 |
Table 2:Screening for Tuberculosis
|
Tuberculosis screening |
|
|
Mantoux positive and Q gold not done |
3 |
|
Mantoux positive and Q gold negative |
7 |
|
Mantoux positive and Q gold positive |
6 |
|
Mantoux negative and Q gold indeterminate |
7 |
|
Mantoux negative and Q gold positive |
4 |
2 drug ATT given to 19 for LTBI,4 drug ATT:3 children for TB disease prior to commencing biologic
Table 3:Adverse event profile:
|
Drug ( No of patients ) |
Side effects |
Total |
|
Infliximab N=58 |
Asymptomatic Mantoux conversion-6 Dengue fever-3 Tuberculosis disease-1 Varicella-1 Hepatitis A infection-1 |
12 |
|
Tocilizumab N=44 |
Prolonged upper respiratory tract infections-4 Dengue fever-3 Pneumonia-1 Gram negative septicemia-1 Herpetic keratitis-1 H1N1 infection-1 Deaths-2 (one Dengue fever with Macrophage activation syndrome, one H1N1 infection) |
11 |
|
Etanercept N=56 |
Uveitis-3 Dengue fever-2 Varicella-2 Autoimmune hemolytic anemia-1 Asymptomatic mantoux conversion-1 Malaria-1 |
10 |
|
Biosimilar Etanercept N=40 |
Skin cellulitis |
2 |
|
Rituximab N=21 |
Herpes zoster-1 Enteric fever-1 |
2 |
|
Biosimilar Adalimumab N=40 |
Herpes zoster-1 |
1 |
|
Golimumab N=6 |
Urinary tract infection |
1 |
|
Abatacept N=3 |
No adverse event |
0 |
|
268 BRMs |
39 |
|
|
Incidence of asymptomatic Mantoux conversion after TNFi exposure
|
15.25/1000 patient years of TNFi exposure |
|
|
Incidence of TB disease after TNFi exposure
|
2.176/1000 patient years of TNFi exposure |
|
Conclusion:
- BRMs can be safely used for prolonged periods of time even in regions where there is a high background incidence of infections
- 39 adverse events occurred on exposure to a BRM in 217 pts.95% recovered without sequelae.2/217 died(0.92% mortality)
- Both Mantoux & Q gold should be done to screen for TB before TNFi, mantoux alone missed 11 latent TB patients that were detected by Q gold
- Annual screen for TB should be done to detect asymptomatic Mantoux conversion to prevent dissemination of disease so that timely prophylaxis can be instituted. Asymptomatic Mantoux converters(n=7, 9.09% of tested patients)were picked up with this protocol.
To cite this abstract in AMA style:
Sawhney S, Shivpuri A, Agarwal M. Safety Of Biological Response Modifiers In Childhood Autoimmune Rheumatic Diseases From A Single North Indian Centre [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 4). https://acrabstracts.org/abstract/safety-of-biological-response-modifiers-in-childhood-autoimmune-rheumatic-diseases-from-a-single-north-indian-centre/. Accessed March 21, 2023.« Back to 2017 Pediatric Rheumatology Symposium
ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-of-biological-response-modifiers-in-childhood-autoimmune-rheumatic-diseases-from-a-single-north-indian-centre/