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Chapter 3.3. Efficiency and safety abatatsepta at children with JUIA.

The efficiency and safety estimation abatatsepta was spent at 30 children with JUIA. From them 8 children (26,7 %) with system and 22 (73,3 %) with articulate variant JUIA.

SYSTEM VARIANT JUIA:

In a subgroup of patients with system variant JUIA from 8 children was 7 (87,5 %) girls and 1 (12,5 %) the boy.

Middle age of children has made 10,25 yo 4,2 years (9,7), from 7 till 16 years, the disease debut fell 2,7 yo 1,4 (2,5) years, average duration of disease before appointment abatatsepta - 7,7 yo 4,1 (6,5).

In a debut of disease at all patients extraarticular implications JUIA, such as a fever, a lymphadenopathy, gepatosplenomegalija, were observed less often, at 4 sick (50 %), was taped mioperikardit, an eruption only at a two (25 %) children. As, at all children in a disease debut ESR substantial increase - 4218,4 (43) mm/ch, SRB - 4,2 yo 2,8 (4,0) mg/dl, quantities of thrombocytes of blood - 427 yo 194 (410) h109/l and leucocytes - 11,8 yo 5,1 (12,1) h109/l became perceptible.

By the appointment moment abatatsepta in a studied subgroup of children of extraarticular implications it has not been noted. At three children (37,5 %) the rhematoid uveitis in an exacerbation stage (at a two - bilateral, at one child - unilateral) - five amazed eyes has been taped.

Proof the joint syndrome in a disease debut was observed at all children. Thus at 1 (12,5 %) from them, the polyarthritis at once was generated, at the others 7 (87,5 %) was observed extending oligoartrit. By the appointment moment abatatsepta the quantity of active joints on the average made 11,9 yo 14,2 (8), joints with mobility restriction - 13,4 yo 14,1 (9). (Table 3.3.1)

Table 3.3.1. The General characteristic of patients, with the system variant JUIA, included in group abatatsepta.

Demographic indicators System variant JUIA М8 (Me)
Quantity of patients (N) 8
Girls/boys 7/1

Middle age, in years 10,25 4,2 (9,7)
Age of the beginning of disease, in years 2,7 1,4 (2,5)
Duration of disease, in years 7,7 yo 4,1 (6,5)
Therapy in the anamnesis
GK perorally 6 (75 %)
Pulse-therapy by Methylprednisolonum 8 (100 %)
v/s injections GK 8 (100 %)
MHT 8 (100 %)
МХТ+ЦиА 7 (87,5 %)
MHT + leflunomid 4 (50 %)
MHT + SSZ 5 (62,5 %)
GIBP 2 (25 %):

1 - infliksimab,

1 - adalimumab

Therapy by the appointment moment abatatsepta
MHT 2 (25 %)
МХТ+метилпреднизолон per os 3 (37,5 %)
leflunomid +метилпреднизолон per os 1 (12,5 %)
МХТ+ЦиА+метилпреднизолон per os 1 (12,5 %)
МХТ+лефлуномид+метилпреднизолон

per os

1 (12,5 %)
Indicators of activity JUIA by the appointment moment abatatsepta
ESR, mm/ch 40 yo 18 (41,5)
SRB, mg/dl 1,8 yo 1,2 (1,5)
Kol-in active joints (N) 11,9 yo 14,2 (8)
Kol-in joints with function restriction (N) 13,4 yo 14,1 (9)
YOURS of the doctor, points 80,6 yo 21 (80)
YOURS of the patient.
Points
82 11,7 (80)
CHAQ, points 1,8 yo 1,3 (1,6)

In the anamnesis before appointment abatatsepta all children received massive basic immunosupressivnuju therapy BPVP in various combinations. 6 (75 %) from 8 children in the anamnesis received GK perorally in the maximum dosage of mass of a body of 1-1,5 mg/kg on Prednisolonum. By the appointment moment abatatsepta the daily average dosage of Prednisolonum at these children made 3,75 yo 1,25 mg/kg. All 8 children (100 %) as, in the anamnesis, received repeated courses pulse - therapies by Methylprednisolonum, VVIG, intraarticulate punctures with introduction GK. As,
All children, as basic therapy received Methotrexatum in a dose of 10-15 mg/m2 a week.

By the appointment moment abatatsepta only two children (25 %) were on monotherapy by Methotrexatum, the others received the combined therapy (table 3.3.1).

Before appointment abatatsepta 4 children had II degree of humoral activity, at other 4 - high III degree of humoral activity. An ESR on the average made 40 yo 18 (41,5) mm/ch, SRB - 1,8 yo 1,2 (1,5) mg/dl. As, in a studied subgroup rising of level of thrombocytes in blood - 412 yo 129 h109/l, substantial increase of immunoglobulins And - 334 yo 162 (305) mg/dl, immunoglobulins G to 2167 yo 923 (2600) mg/dl, small depression of concentration of haemoglobin on the average to 112 yo 16 (110) mg/dl became perceptible. The quantity of leucocytes, erythrocytes, M immunoglobulins remained within age norm. The Russian Federation and ANF have not been taped in one of cases. Only at one girl in the anamnesis has been taped positive ANF.

The general estimation the doctor of activity of illness on YOURS has made 80,6 yo 21 (80) points, an estimation the patient or his parent on YOURS - 82 yo 11,7 (80).

Functional insufficiency of patients by criteria CHAQ before appointment abatatsepta has on the average made 1,8 yo 1,3 (1,5), that on classification Dempster and co-authors there corresponds to serious functional disturbances (table 3.3.1).

EFFICIENCY ABATATSEPTA AT CHILDREN WITH SYSTEM VARIANT JUIA:

In 6 months from the therapy beginning abatatseptom in a studied subgroup of children it is received more than triple depression of quantity of active joints, with 11,9 yo 14,2 (8) to 3,0 yo 4,2 (3,5) (р=0,111). The tendency to depression quantity of joints with function restriction - with 13,4 yo 14,1 (9) to 9,1 yo 14,2 (8) (р=0,553) (Table 3.3.3, a drawing 3.3.1) is noted.

Drawing № 3.3.1 Dynamics of quantity of active joints from joints with restriction of function at children with system variant JUIA against therapy abatatseptom.

Depression of humoral activity has been taped at 7 (87,5 %) from 8 children who have entered into research. Activity of disease remained high with one child. On the average ESR indicators have decreased with 40 yo 18 (41,5) to 18,6 yo 14,5 (17) mm/ch (р=0,02) (a drawing 3.3.2). Level SRB has decreased slightly, and has made in dynamics 1,1 yo 0,7 (1,0) mg/dl (р=0,2). The quantity of thrombocytes was normalised and has averaged 309 yo 92 (280) h109/l. The tendency to depression of immunoglobulins And - to 303 yo 196 (290) mg/dl is noted. The quantity of immunoglobulins G has decreased to normal digits - 1325 yo 371 (1100) mg/dl. As, in 6 months from the therapy beginning abatatseptom it is noted, normalisation of level of haemoglobin in blood (on the average 120 yo 11 (127) mg/dl). The quantity of leucocytes, erythrocytes, M immunoglobulins remained within age norm.

Drawing № 3.3.2 Dynamics of indicators of an ESR at children with system variant JUIA against therapy abatatseptom.


The general estimation the doctor of activity of illness on YOURS has decreased to 47,5 yo 9,6 (45) (р=0,001), an estimation the patient or his parents - to 44,4 17,2 (40) (р=0,001) (a drawing 3.3.3). Functional insufficiency of patients in 6 months from the therapy beginning has made 1,1 yo 1,2 (1) (р=0,281) (Table 3.3.3, a drawing 3.3.4).

Drawing № 3.3.3 Dynamics of indicators YOURS of doctors and patients and-or them

Parents with system variant JUIA against therapy abatatseptom.


Drawing № 3.3.4 Dynamics CHAQ at children with system variant JUIA against therapy abatatseptom.

At a complex estimation of efficiency abatatsepta at children with system variant JUIA, later 6 months from the therapy beginning, ACR pedi-30 have been reached at 7 children (87,5 %), ACR pedi-50 - at 6 (75 %), ACR pedi-70 - at 3 (37,5 %). At two children it was possible to stop an exacerbation of a rhematoid uveitis (one child with the bilateral uveitis, the second - with unilateral). Therapy abatatseptom has appeared noneffective at one girl (12,5 %) (Table 3.3.4, a drawing 3.3.5).

By 12 months of research the quantity of active joints and joints with mobility restriction continued to decrease to 2,6 yo 4,1 (2,5) and 8,6 yo 7,4 (8) accordingly (a drawing 3.3.1). The further depression of humoral activity has been taped at 7 children. The ESR average index has decreased with 40 yo 18 (41,5) to 17,2 yo 16 (16,2) mm/ch (р=0,018) (0 and 12 months), quantity SRB was normalised at all patients (a drawing 3.3.2). The quantity of thrombocytes, leucocytes, erythrocytes, immunoglobulins And, M, G remained within age norm.

Indicators YOURS of the doctor and YOURS of the patient remained without essential dynamics in comparison with the results received in 6 months from the beginning of therapy and have made accordingly 46,4 yo 12 (42), 43 yo 16,3 (41) points (a drawing 3.3.3). Functional insufficiency of patients in 12 months from the therapy beginning has made 0,95 yo 0,55 (0,7) (a drawing 3.3.4, table 3.3.3).


At a complex estimation later 12 months in a subgroup of patients with system variant JUIA ACR pedi-30 have been reached at all 8 children (100 %), ACR pedi-50 - at 6 (75 %) ACR pedi-70 - at 6 (75 %), ACR pedi-80 at 3 (37,5 %), ACR pedi-90 - at 1 (12,5 %). At two children against a 12-month's course of therapy abatatseptom 30 % improvement have been reached only, high humoral activity of disease, an exacerbation of an articulate syndrome remained; at one girl the exacerbation of a bilateral rhematoid uveitis, therapy abatatseptom remained has been stopped. One child, with a uveitis, is translated on therapy adalimumabom, the second - on therapy etanertseptom (table 3.3.4, a drawing 3.3.5).

By 18 months efficiency abatatsepta managed to be estimated only at 5 children: two girls, have left research in connection with insufficient efficiency of a preparation, one more child has not reached 18-month's duration of course of treatment by the moment of the termination of research. At remained 5 children the quantity of active joints on the average has made 1,1 yo 0,4 (1,5), joints with function restriction - 3 yo 1,3 (2,5) (a drawing 3.3.1). At 4 from 5 and children normalisation of indicators of an ESR (average value - 3,5 yo 5,6 (4) mm/ch), SRB (average value - 0,4 yo 0,3 (0,2) mg/dl) (a drawing 2.3.2) is noted. The quantity of leucocytes, thrombocytes, immunoglobulins A, M, G, level of haemoglobin of blood were within age norm. YOUR indicator of the doctor has decreased on the average to 40,2 yo 14 (38) points, YOURS of the patient and-or parents - to 25,7 yo 11 (25) points, level of functional insufficiency - to 0,65 yo 0,5 (0,8) (a drawing 3, table 3.3.3).

At one girl, from 90 % the answer to therapy abatatseptom by 12 months of therapy, in 18 months had been fixed a disease exacerbation: narosli articulate a syndrome, humoral and immunologic activity. By results of a complex estimation by this time general efficiency has decreased to 30 % of improvement on criteria ACR pedi. In this connection, further, the girl has been translated on therapy etanertseptom with achievement of good results.

At other 4 children (80 %) by 18 months from the therapy beginning, 70 % improvement by criteria ACR pedi, at a three (60 %) - 80 % improvement (table 3.3.4, a drawing 3.3.5) have been reached at least.

By 18 months of therapy abatatseptom, Prednisolonum per osпродолжала to receive only one girl in a dosage of 0,05 mg/kg/days At other children peroral GK have been cancelled. By this period at other child it was possible to cancel leflunomid, the girl continued to receive the combined therapy by Sulfasalazinum and abatatseptom with good effect. To one more girl cyclosporine has been excellent And and Methylprednisolonum, therapy by Methotrexatum and abatatseptom is continued.

As, against therapy abatatseptom frequency of carrying out of intraarticulate injections with introduction GK and frequency of appointment of pulse-therapy by Methylprednisolonum has authentically decreased. The methods of treatment set forth above were spent only to a three (37,5 %) to children, therapy abatatseptom at which has appeared insufficient.

The adherence indicator to therapy abatatseptom at children with system variant JUIA after 12 months has made 1, and in 18 months - 0,714. Value of indexes LUNDEX are presented in the table № 3.3.2.

The table № 3.3.2. Index LUNDEX at children with system variant JUIA against therapy abatatseptom.

I.Lundex 6 mes (n=8) 12 mes (n=8) 18 mes (n=5)
ACR pedi 0 0,125 - -
ACR pedi 30 0,875 1 0,714
ACR pedi 50 0,75 0,75 0,57
ACR pedi 70 0,375 0,75 0,57
ACR pedi 80 - 0,375 0,428
ACR pedi 90 - 0,125 -

Thus, by 18th month from the therapy beginning abatatseptom at half of children 70 % the answer by criteria ACR pedi have been reached.

At one child in a subgroup of children with system variant JUIA on 4th month from the therapy beginning, it has been fixed disturbance of the scheme of treatment abatatseptom (an introduction delay for 2 weeks), that has led to the expressed exacerbation of an articulate syndrome and a rhematoid uveitis. After therapy renewal abatatseptom achievements received before the good answer to spent therapy it has not been noted. Further, this girl has been translated on therapy adalimumabom, in connection with low efficiency of spent therapy abatatseptom. For all observable period at one of children it has not been fixed developments of extraarticular implications JUIA.

Application abatatsepta differed good shipping and high degree of safety. In one of observable cases development of the undesirable phenomena has not been noted.

The table № 3.3.3 Dynamics of indicators of activity of disease against

Treatments abatatseptom at children with system variant JUIA.

0 mes

(n=8)

Myob (Me)

6 mes

(n=8)

Myob (Me)

12 mes (n=8)

Myob (Me)

18 mes (n=5)

Myob (Me)

Kol-in active joints (N) 11,9 yo 14,2 (8) 3,0 yo 4,2 (3,5) 2,6 yo 4,1 (2,5) 1,1 0,4 (1,5)
Kol-in joints from TNFS (N) 13,4 yo 14,1 (9) 9,1 yo 14,2 (8) 8,6 yo 7,4 (8) 3,0 yo 1,3 (2,5)
ESR, mm/ch 40,0 yo 18,0

(41,5)

18,6 yo 14,5

(17) *

17,2 yo 16,0

(16,2) *

3,5 yo 5,6

(4) **

YOURS of the doctor, 80,6 yo 21,0 47,5 yo 9,6 46,4 yo 12,0 40,2 yo 14,0
Points (80) (45) ** (42) ** (38) *
YOURS of the patient and-or parents. 82,0 yo 11,7 44,4 yo 17,2 43,0 yo 16,3 25,7 yo 11,0
Points (80) (40) ** (41) ** (25) **
CHAQ, points 1,8 yo 1,3 (1,5) 1,1 yo 1,2 (1) 0,95 yo 0,55 (0,7) 0,65 yo 0,5 (0,8)

** р=0,001, * 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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  11. THE TABLE OF CONTENTS
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  14. Chapter 3.2. Efficiency and safety etanertsepta at children with JUIA.
  15. Chapter 3.3. Efficiency and safety abatatsepta at children with JUIA.
  16. CHAPTER 4. EFFICIENCY AND SAFETY GIBP COMPARISON (INFLIKSIMABA, ETANERTSEPTA AND ABATATSEPTA) AT CHILDREN WITH JUIA.
  17. CHAPTER 4.1. Efficiency and safety GIBP comparison (infliksimaba, etanertsepta and abatatsepta) at children with system variant JUIA.
  18. CHAPTER 4.2. Efficiency and safety GIBP comparison (infliksimaba, etanertsepta and abatatsepta) at children with articulate variant JUIA.
  19. THE LITERATURE LIST: