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CHAPTER 4.2. Efficiency and safety GIBP comparison (infliksimaba, etanertsepta and abatatsepta) at children with articulate variant JUIA.

The group of children with articulate variant JUIA included 64 children. During work 64 clinical cases of application GIBP are surveyed.

Most of all children was in group etanertsepta - 32 persons, least, in group infliksimaba - 10 children.

The group abatatsepta included 22 children.

In groups etanertsepta and abatatsepta children were comparable to a sexual sign: the quantity of girls several times prevailed over quantity of boys. In group infliksimaba on the contrary, the quantity of boys was in 4 times above in comparison with quantity of girls.

Middle age of children, age of the beginning of disease, duration of disease had no strong differences in studied groups (table 4.2.1).

At comparison of prevailing forms JUIA in investigated groups, a number of differences has been taped. In group etanertsepta all children were with polyarticulary variant JUIA, thus, at a two from them was observed positive across the Russian Federation
Variant of a current of disease. In group etanertsepta children with a polyarticulary variant of current JUIA also prevailed, however, more than 30 % of children who have entered into research were with extending oligoartritom. Feature of group infliksimaba was that children have entered into it with entezitnoj form JUIA (30 %) that was not in other groups.

The table № 4.2.1 Comparative characteristic of patients with the articulate

Variant JUIA, entered into research.

Demographic indicators Infliksimab Myob (Me) Etanertsept Myob (Me) Abatatsept Myob (Me)
Quantity of patients (N) 10 32 22
Girls/boys 2:8 (1:4) 29:3 (9,7:1) 19:3 (6,3:1)
Middle age, in years 12,5 yo 3,4 (13) 10,3 yo 3,6 (10) 11 yo 3,9 (11)
Age of the beginning of disease, in years 7,0 yo 4,2 (7) 5,0 ±3,8 (4,5) 5,8 ±3,8 (4,5)
Duration of disease, in years 5,5 + 3,8 (4) 5,6 yo 3,8 (5) 5,4 yo 3,7 (4,25)
Variants of articulate form JUIA:

• the polyarticulary Russian Federation -

• extending oligoartrit the Russian Federation -

• the polyarticulary Russian Federation +

• entezintaja form JUIA

6 (60 %)

1 (10 %)

3 (30 %)

30 (93,75 %)

2 (6,25 %)

15 (68,2 %)

7 (31,8 %)

Therapy in the anamnesis
GK perorally 5 (50 %) 6 (18,75 %) 5 (22,7 %)
Pulse-therapy by Methylprednisolonum 10 (100 %) 9 (28 %) 13 (59 %)
v/s injections GK 10 (100 %) 26 (81 %) 22 (100 %)
MHT 100 (100 %) 32 (100 %) 22 (100 %)
МХТ+ЦиА 5 (50 %%) 6 (18,75 %) 2 (9,1 %)
MHT + leflunomid 2 (20 %) 6 (18,75 %) 4 (18,2 %)
MHT + SSZ 7 (70 %%) 12 (37,5 %) 8 (36,4 %)
GIBP - 1 (3,13 %) - adalimumab -
Indicators of activity JUIA by the appointment moment abatatsepta
ESR, mm/ch 43,4 yo 15,3 (47) 30,4 yo 18 (28) 19,7 yo 13,3 (18)
SRB, mg/dl 8,4 yo 4,7 (8) 2,5 yo 3,3 (3) 2,1 yo 1,3 (1,5)
Kol-in active joints (N) 13,5 yo 10,4 (9,5) 14,8 yo 10,0 (15) 10,3 yo 9,4 (8)

Kol-in joints with function restriction (N) 13,6 yo 10,0 (9,5) 17,4 yo 13,6 (17) 10,0 yo 9,6 (8)
YOURS of the doctor, points 98,7 yo 2,0 (100) 78,1 yo 10,4 (90) 80,7 yo 9,0 (80)
YOURS of the patient, points 97 yo 6,4 (100) 72,3±18,0 (90) 68,0 yo 29 (72)
CHAQ, points 2,87 yo 0,14 (2,2) 1,9 yo 0,7 (2) 1,5 yo 0,9 (1,5)

All children before appointment GIBP received massive basic immunosupressivnuju therapy 2-mja and more preparations. Half of children from group infliksimaba in the anamnesis received GK perorally in the maximum dosage of 1-2 mg/kg/days In groups etanertsepta and abatatsepta kolichestivo children using in anamnesis GK perorally, was much more low, and has made 18,75 %, 22,7 % accordingly.

As, all children, in the anamnesis, as basic therapy applied Methotrexatum (MHT) in a dose of 10-15 mg/m2 a week.

By quantity of active joints for a moment initsiatsii studied groups were comparable. The quantity of joints with function restriction in group etanertsepta was above in comparison with other groups.

At comparison of laboratory indicators, it is obvious, that the group infliksimaba included children with higher humoral and immunologic activity. In turn, in group abatatsepta, children with smaller indicators of an ESR and SRB were observed.

Indicators YOURS of the doctor, YOURS of the patient and CHAQ, for a moment initsiatsii as were above in group infliksimaba in comparison with groups etanertsepta and abatatsepta.

Summarising the data cited above, it is possible to draw a conclusion that the group infliksimaba included children with the most serious current JUIA. Patients, on the contrary, have been included In group abatatsepta with smaller humoral activity, with smaller quantity of the amazed joints, with larger functional activity of children (Table 4.2.1).

In 6 months from the beginning of therapy of 50 % improvement by criteria ACR pedi has been received more than at 70 % of children in all studied groups. Thus, in group infliksimaba the highest efficiency is taped: at all children

70 % improvement on ACR pedi became perceptible at least, and at half of children development of clinico-laboratory remission (ACR pedi 90,100) has been fixed. Frequency of development of remission against therapy etanertseptom and abatatseptom, in 6 months from initsiatsii, was authentically more low (r 0,05).

In 24 months from the therapy beginning small depression of efficiency infliksimaba becomes perceptible. In turn, efficiency etanertsepta and abatatsepta continued to accrue. 50 % improvement have been received at all children,


Entered under observation. 80 % the answer by criteria ACR met in group etanertsepta and abatatsepta in comparison with infliksimabom is much more often, however, authentic a difference has not been received (p> 0,05).

Medicamental clinico-laboratory remission (ACR pedi 90-100) in group abatatsepta has been reached at 67 % of children, in group etanertsepta - at 43 %. Against therapy infliksimabom, by 24 months from the therapy beginning, in one of observable cases development medicamental klinikoyolaboratornoj remissions (table 4.2.6, a drawing 4.2.5) was not observed.

The table № 4.2.6. Comparison of efficiency GIBP by criteria ACR pedi

In 24 months from initsiatsii at children with articulate variant JUIA.

24 months infliksimab, n=4 etanertsept, n=28 abatatsept, n=6
ACR pedi 0 0 % 0 % 0 %
ACR pedi 30 100,0 % 100 % 100,0 %
ACR pedi 50 100,0 % 100,00 % 100 %
ACR pedi 70 75,0 % 96,40 % 100 %
ACR pedi 80 25,0 % 78,60 % 83 %
ACR pedi 90 0 % 43,00 % 67 %
ACR pedi 100 0 % 14,30 % 50 %

Drawing № 4.2.5. Comparison of efficiency GIBP by criteria ACR pedi

In 24 months from initsiatsii at children with articulate variant JUIA.


In 24 months from the beginning of therapy GIPB the adherence factor to therapy at children with articulate variant JUIA in group infliksimaba was peer - 0,8, group etanertsepta - 0,94, abatatsepta - 0,6.

At comparison of efficiency GIBP with use of indexes LUNDEX following results are received. The greatest efficiency is noted in group etanertsepta where index LUNDEX to ACR pedi 50 has made 0,94, infliksimaba the index was peer group 0,8. The least indicator has been received in group abatatsepta - 0,6. An authentic difference in the received results it has not been noted (> 0,05). The indicator of indexes LUNDEX to ACR pedi 80,90,100 was authentically above in groups etanertsepta and abatatsepta in comparison with group infliksimaba (r

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Scientific source Loskutova Olga Jurevna. Efficiency and safety of genno-engineering biological preparations (infliksimab, etanertsept, abatatsept) at children with various variants juvenilnogo an idiopathic arthritis. The DISSERTATION on competition of a scientific degree of the candidate of medical sciences. Moscow - 2014. 2014

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  5. THE TABLE OF CONTENTS
  6. INTRODUCTION
  7. Infliksimab
  8. Abatatsept
  9. comparative efficiency and safety GIBP.
  10. Chapter 2. MATERIALS And METHODS.
  11. Chapter 3.1. Efficiency and safety infliksimaba at children with JUIA.
  12. Chapter 3.2. Efficiency and safety etanertsepta at children with JUIA.
  13. Chapter 3.3. Efficiency and safety abatatsepta at children with JUIA.
  14. CHAPTER 4. EFFICIENCY AND SAFETY GIBP COMPARISON (INFLIKSIMABA, ETANERTSEPTA AND ABATATSEPTA) AT CHILDREN WITH JUIA.
  15. CHAPTER 4.1. Efficiency and safety GIBP comparison (infliksimaba, etanertsepta and abatatsepta) at children with system variant JUIA.
  16. CHAPTER 4.2. Efficiency and safety GIBP comparison (infliksimaba, etanertsepta and abatatsepta) at children with articulate variant JUIA.