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Dr. Sanjiv N Amin, MD.3rd Floor Bombay Mutual Terrace, 534 Mamasaheb Varerkar Bridge, Mumbai 400007
Indian Perspective :Use of Biologic therapy in Rheumatoid Arthritis in resource limited setting -Challenges and Solutions
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RA - Challenges – India Perspective…
The RA patients in India needing Biologics
Treat to Target, in Clinical Practice, Real Life –•unrealistic attaining DAS (ESR) <2.6, use Physician Global, Hb rise, NSAID count…
Latent Tuberculosis Infection•TST, Interferon γ release assays, Empiric ATT
Switch or swap TNFi
Paradigm shift of treatment of RA in India
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Over 1.5 million patients estimated to suffer from RA in India…
^ Population- 1.26 billion in India
^ 20% -have the ability to pay for quality private healthcare
^ Prevalence : 0.5-0.7% of population in most countries
Over 1.5 million affording
population estimated to
suffer from RA
Methotrexate (MTX) monotherapy
Combination therapy – MTX plus DMARDs
Combination therapy – Biologic plus
MTX/DMARDs
Multiple treatment protocols are followed – biologics are prescribed only if monotherapy with MTX or a combination of MTX and DMARDs fail
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West India rheumatology practice in 2007
Characteristic West IndiaN = 757
BeStN = 508
Mean age (years) 46.82 ± 12.48
54
Women 630 (83.2%) 70 %
Body mass index men women
23.99 ± 5.9423.88 ± 5.04
Mean disease duration < 24 months > 24 months
268489
AllNone
Anti CCP results available 402
X-ray hands & anti CCP results available 152
Family history +ve for RA 86 (11.36%)
Mean DAS 6.25 4.5
• MTX 15 mg 618
MTX + LEF 97
LEF 20 mg OD 07
SLZ 1 Gm BD 9
SLZ + HCQ 6
MTX + SLZ + HCQ 6
MTX + SLZ 14
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West India Rheumatology Practice in 2007
Reduction inDAS > 1.2
Low diseaseDAS < 3.2
RemissionDAS < 2.6
MTX at visit 1
MTX+SLZ at visit 2
MTX+SLZ+HCQ
at visit 2
MTX+LEF at visit 2
No of Patients
618 618+18 618+07 618+102
Mean (SD) DAS at V1
6.251.37
Mean (SD) DAS at V3
4.52 1.38
4.38 1.46
4.38 1.40
4.5 1.38
No (%) of patients with DAS<2.6 at V3
53 (7.51%)
46 (7.23%)
46 (7.36%)
48 (6.66%)
V2 V3 V2 V3 V2 V30
102030405060708090
100
45.461.4
6.316.1
2.4 6.1
54.638.6
93.783.9
97.6 93.9
Improved Not Improved
Perc
enta
ge o
f pati
ents
Overall Disease Outcome: MTX at Visit 1 →Combination at Visit 2
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West India rheumatology practice in 2007: Summary of observations
• Methotrexate 15 mg/week SC or IM : well tolerated and improvement of DAS > 1.2 in half the patients
• Around 20% patients attain low disease activity• Less than 10% attain remission or DAS <2.6.
“Methotrexate 25 mg/week may improve outcomes as indicated by the recent BeSt study”
• Early intervention with MTX and other DMARDsBetter outcome:
• Combinations of MTX + SLZ ± HCQS or MTX + LEF
Better outcome or similar outcome than MTX alone
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7
Overview of Patients on Tocilizumab: 2009
• First patient infused : Feb
2009
• Total no of patients on
Tocilizumab in 6 months: 25
• No. of Patients analyzed : 25 RA
Total No of patients 25
No of patients judged responders 20 (80%)
No of patients judged non responders 5 (20%)
No of Cases 25
Age (years) Mean Range
45.4317 – 73 Yrs.
Sex (%) Male Female
05 (20%)20 (80%)
Disease Duration Mean Range
9.90.5 – 26 Yrs.
X ray Hands (%)Erosion (Present)Joint Space Narrow
24/25 (96%)23/25 (92%)
Biologic naïve patientsExposed to biologics
187 (TNF NR)
Out of the 7 patients who were exposed to TNFi5 responded well to therapy with Tocilizumab.
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Tocilizumab 2010: Sustained improvement in DAS 28
Duration in Months Mean DAS 28 Mean + SD
Responders Non Responders
Mean Change (M0 – M3) -2.19 ± 0.75 (36.1%) -0.54 ± 0.30(7.8%)
Mean Change (M0 – M6) -2.84 ± 1.14 (45.4%) -0.13 ± 0.0 (2%)
Baseline 3 months0
2
4
6
8
10
12
14
6.06
3.87
6.97
6.43
Non respondersResponders
Baseline 6months02468
101214
6.25
3.41
6.39
6.26
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Tocilizumab 2010: Clinically Important Reduction in CRP
Duration in Months Mean CRP (Mean + SD)
Responders Non Responders
Mean Change (M0 – M3) -27.68 ± 22.14 (70.8%) -9.29 ± 22.65 (20.7%)
Mean Change (M0 – M6) -33.99 ± 25.38 (82.2%) 18.3 ± 0.0 (61.4%)
Baseline 6 months0
10
20
30
40
50
60
70
80
41.33
7.34
29.8
18.3
Baseline 3 months0
10
20
30
40
50
60
70
80
90
39.12
11.44
44.79
35.5Non respondersResponders
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Tocilizumab 2010: Improvement in Anemia Status
Duration in Months Mean Hb Mean + SD
Mean Change (M0 – M3) 1.36 + 1.28(13.8%)
Mean Change (M0 – M6) 1.57 + 1.52(15.8%)
Baseline 3 months 6 months9
9.5
10
10.5
11
11.5
12
9.86
11.22
11.5
Haemoglobin
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In the Real World, West India: Tocilizumab 2010...
Initial experience of Tocilizumab is encouraging • “biologic naïve” • “heavily pre-treated”
RA patients• few non responders
Significant improvement within 1 month of TCZ →continued to improve with time• ↓ Mean SJC/TJC, &
DAS• ↓ CRP , ↑
Hemoglobin
No adverse effects were observed during the 12.6 patient years
Tocilizumab is a new safe &
effective treatment option for RA patients.
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Overview of Patients in West India, on Etanercept 25 mg Biosimilar: 2013-2014
Parameters RANumber of patients
19
Gender M=4, F=15Mean age (yrs) 42.8+14.06
Mean disease duration (in years)
9.95
Past history of TB 3BMI 24.0+4.8
Past history of Biologics
1- INF4- TCZ
Patients on Etanercept Biosimilar
83
Number of patients analyzed-
58
Ankylosing Spondylitis
39
Rheumatoid Arthritis 19
Etanercept Biosimilar dose received
25 mg sc. once a week
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ACR 20 & 50 responders at Visit 2 (20 weeks)- Etanercept 25 mg Biosimilar 2013-14
ACR 20 responders ACR 50 responders0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
45.0 42.1
5.3
ACR Response
%ag
e of
resp
onde
rs
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DAS 28 score- Etanercept 25 mg Biosimilar 2013-14
Baseline Visit 2- 20 weeks0
2
4
6
8
10
12
14
16
18
20
12
4
7
11
0
1
Low- DAS 28<2.6Moderate- DAS 28 3.2-5.4High- DAS 28>5.4
DAS Score
6.06 + 1.04 4.79 + 1.42 Mean DAS 28 scores
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Reduction in Inflammatory Markers - Etanercept 25 mg Biosimilar 2013-14
Baseline Visit 248
50
52
54
56
58
60
6261.32
52.8
ESR
ESR
Baseline Visit 205
101520253035404550
45.42
14.18
CRP
CRP
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TB prophylaxis - Etanercept 25 mg Biosimilar, 2013-14
• All patients were started on TB prophylaxis
• Drugs given were Rifampicin 450 mg + Isoniazid 300 mg
• Duration of treatment was 6 months
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Summary: Etanercept 25 mg Biosimilar 2013-14
Etanercept biosimilar
TNFα bio similar is effective in ‘change’ of disease activity in RA in the Indian patients
Safety profile
High with just one injection site reaction in 83 patients
ProphylaxisRifampicin + Isoniazid could be effective in a TB endemic
population
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HIV and TB1. “In resource-constrained settings with high TB incidence and transmission,
adults and adolescents living with HIV, who have an unknown or positive tuberculin skin test (TST) status and among whom active TB disease has been safely ruled out, should receive at least 36 months of IPT. IPT should be given to such individuals regardless of whether or not they are receiving ART. IPT should also be given irrespective of the degree of immunosuppression, history of previous TB treatment, and pregnancy.”
2. Empirical tuberculosis therapy did not reduce mortality at 24 weeks compared with isoniazid preventive therapy in outpatient adults with advanced HIV disease initiating antiretroviral therapy. The low mortality rate of the trial supports implementation of systematic tuberculosis screening and isoniazid preventive therapy in outpatients with advanced HIV disease.
3. The optimal duration of preventive therapy for tuberculosis (TB) among HIV-infected persons in TB-endemic countries is unknown. The 6EH and 36H regimens were similarly effective in preventing TB, when compared to historical incidence rates. However, there was a trend to lower TB incidence with 36H. There was no increase in isoniazid resistance compared to the expected rate in HIV-infected patients.
1. WHO Global TB Program 2015 update;2. Lancet 2016; 387: 1198–2093. www.plosone.org Dec 2012, Vol 7, Issue 12
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Parameters RA (N=64)Gender Male=11, Female= 53Mean age in yrs. ± SD 45± 15.45Mean disease duration in months ±SD
84 ±74.95
Past history of Tuberculosis
2
BMI in kg/m2 ± SD 22.82±5.6Past history of Biologics Total=26
02- REM04- ETA09- TCZ05- ETA-TCZ01- ETA-REM03- ETA-REM-TCZ01- ETA-EXEM01- ETA-EXEM-TCZ
West India rheumatology practice in 2016 -Infliximab Biosimilar
Past history of RA patients(N=64)
No. (percentage)
DM 5 (7.8%)
Hypertension 14 (21.8%)
CAD 2 (3.1%)
Hypothyroid 6 (9.3%)
TB 2 (3.1%)
Microscopic polyangiitis
1 (1.5%)
Peptic ulcer 1 (1.5%)
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West India rheumatology practice in 2016, Infliximab Biosimilar
Extra articular manifestation
RA(N=64)
Iron deficiency anemia
1
Psoriasis 4
Sacroilitis 1
Sjogren 4
Uveitis 1
AAD 1
Subcutaneous nodule
2
DMARDs prior (N=64) No. (Percentage)Corticosteroids 10 (15.6%)MTX 6 (9.37%)MTX+LEF 10 (15.6%)MTX+SLZ± HCQS 47 (73.4%)No 1 (1.5%)
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Physicians assessment of patients (N=64)
Responder 25 (39.06%)
Non-responder and ADRs
39 (60.93%)
Outcomes with of Infliximab Biosimilar, Real Life -2016 Western Rheumatology Practice
Adverse Reaction (N=64)
None 58 (90.6%)Abdominal pain 1
Anaphylaxis 1Giddiness 1
RHUPUS flare 1Urticaria 2
Switched to other biologics (N=17)
ETAbs 25 2 (11.7%)
RTX 7 (41.1%)
TCZ 8 (47%)
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Baselin
e
3 - 4 m
t F UP
6-12 mt F
-up0
2
4
6
8
10
12
5.11
3.60 3.47
5.79
5.09
DAS 28Non responder
Responder
Baseline 3 - 4 mt F UP 6-12 mt F-up0
10
20
30
40
50
60
70
80
90
39.13
16.7013.70
42.80
36.67
SDAI
Efficacy with Infliximab Biosimilar in Real Life-2016 Western Rheumatology Practice
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Baselin
e
3 - 4 m
t F UP
6-12 mt F
-up05
1015202530
11.08
3.64 3.40
15.03
12.39
Tender Joint
Baseline 3 - 4 mt F UP 6-12 mt F-up0123456789
10
3.96
0.92 1.20
5.56
4.14
Swollen Joint
Baseline 3 - 4 mt F UP 6-12 mt F-up0
20406080
100120140
56.54 58.81 55.00
59.67 60.46
Body weight
Physical parameters with Infliximab Biosimilar-2016 Western Rheumatology Practice
Non responder
Responder
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Baseline 3 - 4 mt F UP 6-12 mt F-up0
20406080
100120140
59.36
32.7647.29
61.36
58.36
ESR
Baseline 3 - 4 mt F UP 6-12 mt F-up0
10203040506070
33.05
12.327.63
32.39
28.16
CRP
Baseline 3 - 4 mt F UP 6-12 mt F-up0
5
10
15
20
25
9.75 11.13 11.62
10.0910.42
Hemoglobin
Laboratory Parameters with Infliximab Biosimilar -2016 Western Rheumatology Practice
Non responder
Responder
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COHORT RESPONDER NON-RESPONDER
1 biologic failure (N=15)
5-TCZ4-ETAbs2-INF
4-TCZ
>1 biologic failure (N=11)
1 10
Previous biologic failure (N=26)
12 (46.15%) 14 (53.84%)
Biologic Naïve(N=35)
13 (37.14%) 22 (62.85%)
Overall (N=64*)
25 (40.98%) 35 (59.01%)
Physicians assessment with Infliximab Biosimilar in different cohorts
*3 patients – ADRs -- Omitted
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Series10%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
45.4
16
15.44
23.16
MTx Combination DMARDsBiologics Unmet need
Treatment responders, West India, 2007 to 2016, with available csDMARD & bDMARDs
20
32
40
8
No improvement
LDAS: Mean DAS lowering > 1.2
DAS: 2.6 and 3.2
DAS< 2.6
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Does physician’s assessment correlate with DAS 28 score?
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Infliximab Biosimilar RA cohort(N=64)
R NRRemission: DAS< 2.6 5 3
DAS 2.6 and 3.2 8 0
Mean DAS lowering of 1.2 or more 10 12
No improvement 2 24*
Total 25 39
Correlation of DAS with Physicians Outcome- Infliximab Biosimilar
*3 patients – ADRs
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If TNFi Fails, Should I Switch to Another TNFi or a Biologic With A Different MOA?
QUESTION:
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Comparison of Drug Discontinuation due to Inefficacy and Adverse Events Between
Anti TNF Agents & Non-Anti-TNF biologic Agents in
Anti-TNF Inadequate Responder RA Patients
Martin-du-Pan S, et al. ARD 2012;71(6):997-999
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Comparison of Drug Discontinuation to Inefficacy & Adverse Events Between Anti-TNF Agents & Non-Anti-TNF Biologic Agents in Anti-TNF Inadequate Responder RA Patients (SCQM - Swiss Registry)
Results:• Based on 1485 treatment courses: 853 alternate anti-TNF; 632 non-anti-TNF
Martin-du-Pan S, et al. ARD 2012;71(6):997-999.
Time to Discontinuation of Biologic Agents
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In real life, in EU….
• In TNFi-IRs, biologic agents with a different mode of action appear to have lower drug discontinuation rates than alternative anti-TNF agents – regardless of reason for discontinuation
• Caveats:– Non RCTs for comparison data – More data needed with multiple previous TNF-IRs
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DIFFERENT COHORTS INFLIXIMABbs OUTCOME FATE OF INFLIXIMABbs NON-REPONDERS
Responder Non-responder Shift to Responder Non-responder
Biologic naïve pts 1322
(3 ADRs)
3-RTX5-TCZ2- ETAbs12-DMARDs
2-RTX 4-TCZ1-ETAbs
1 (Death)1-TCZ1-ETAbs
Prior TCZ Rx before Infimab
513
4-RTX2-TCZ7-DMARDs
1-RTX1-TCZ
3-RTX1-TCZ
Prior INF Rx before Infimab
3
Prior ETAbs 25Rx before Infliximabbs
4
Prior ADAbsRx before Infliximabbs
1 1- TCZ 1-TCZ
Total 25 36* 17-shift to biologics
9 8
Fate of non-responders with Infliximab Biosimilar in different cohorts, West India, 2016, real life…
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• Around 60% patients have meaningful response to DMARDs, of which 25% have low disease activity or remission
• Adding a TNF inhibitor adds another 15% have meaningful response, of which 50% have low disease activity or remission
• Empirical primary TB treatment for 4 months can be an option for patients prescribed TNFi
• If one Biologic fails, swap to another MOA Biologic may be better than a switch. If two Biologics fail, chance of the third being effective is small
• Change from innovator Infliximab to biosimilar Infliximab was tolerated and remained effective in three patients
Rheumatoid Arthritis- West India, Real Life...
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At The End of The Day….
The Trend is to Optimize The Use of Current Biologics
But……
We Still Have A Long Way to Go For A Paradigm Shift In Improving RA!
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Baricitinib, oral reversible inhibitor of JAK 1 & 2, interferes inflammation mediated by IL-6, IL-12, IL-23 and Interferon α
RA BEACON, Taylor PC, Keystone EC, van der Heijde D et al. Arthritis Rheumatology 2015;67 (Supplement 10)
Placebo Baricitinib Adalimumab
ACR 20 40% 70% 61%
ACR 50 17% 45% 31%
ACR 70 5% 19% 13%
The ADACTA study (not a usual care study without radiographicdata) showed a clear superiority of Tocilizumabmonotherapy against Adalimumab
Gabay C, Emery P, van Vollenhoven R et al.Lancet 2013;381:1541-50
Smart pricing of oral JAK 1 & 2 inhibitors, compared with bDMARDs, will change rheumatoid arthritis treatment algorithms!
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And, Take Home Thoughts….
Make in India !
FIRE IN THE BLOOD
2013 documentary by Dylan Mohan Gray
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THANK YOU!!!!!