Ensayo controlado, aleatorizado y

REVISION DE ARTICULO
de dos años de
duración de belimumab en la
Nefritis Lupica
ESTUDIANTES: BARRETO RAMOS EBER LEANDRO
FLORES CHOQUE EDDY ALVARO
GAMBOA SAMBONINO LEONARDO MARTIN
GARCIA MALLCU FERNANDO DEYMAR
HERING CANAVIRI ABDUL HAMILTON
LAYME GUZMAN MARIA JOSE
MUÑOZ MOLINA DANIEL MAURICIO
QUISPE TORREZ DANIELA SOLEY
RAMOS CRUZ XIMENA
SANJINES ARANCIBIA GABRIEL
VIDAURRE ALANES ALEXIS
CURSO: 4”A”
DOCENTE: DR. HUARACHI FLORES JHONNY
GESTION: 2023
 QUE ES ?
La nefritis lúpica es una complicación frecuente en
personas que tienen lupus eritematoso sistémico, más
comúnmente conocido como lupus.
La nefritis lúpica se produce cuando los anticuerpos del lupus
afectan a estructuras en los riñones, que filtran los desechos. Esto
causa inflamación renal y puede llevar a que se presente sangre
en la orina, proteína en la orina, presión arterial alta, deterioro de
la función renal o incluso insuficiencia renal.
FONDO
En adultos con nefritis lúpica activa, se desconocen
la eficacia y seguridad de belimu-mab intravenoso
en comparación con placebo, cuando se agrega a la
terapia estándar (micofenolato de mofetilo o
ciclofosfamida-azatioprina).
METODOS

En un ensayo de fase 3, multinacional, multicéntrico, aleatorizado, doble ciego,

controlado con placebo, de 104 semanas de duración, realizado en 107 sitios en 21
países, asignamos a adultos con nefritis lúpica activa comprobada por biopsia en
una proporción de 1:1 para recibir belimumab intravenoso (a una dosis de 10 mg
por kilogramo de peso corporal) o placebo equivalente, además de la terapia
estándar.
El criterio de valoración principal en la semana 104 fue una respuesta renal de eficacia
primaria (una proporción de proteína urinaria a creatinina de ≤0,7, una tasa de filtración
glomerular estimada [TFGe] que no era peor que un 20% por debajo del valor antes del
brote renal (pre- valor de llamarada) o ≥60 ml por minuto por 1,73 m2 de superficie
corporal y ningún uso de terapia de rescate).
Y el criterio de valoración secundario principal fue una respuesta renal completa (una
proporción de proteína urinaria a creatinina de <0.5, TFGe que no era peor que un 10%
por debajo del pre-valor de llamarada o > 90ml por minuto.
 RESULTADOS
Un total de 448 pacientes fueron aleatorizados (224 al grupo de belimumab
y 224 al grupo de placebo).
En la semana 104, más pacientes en el grupo de belimumab que en el grupo
de placebo tuvieron una respuesta renal de eficacia primaria (43% vs. 32%;
odds ratio, 1,6; intervalo de confianza [IC] del 95%, 1,0 a 2,3; P = 0,03 ) y
una respuesta renal completa (30% frente a 20%; odds ratio, 1,7; IC del
95%, 1,1 a 2,7; P = 0,02).
El riesgo de un evento relacionado con el riñón o de muerte fue menor entre
los pacientes que recibieron belimumab que entre los que recibieron
placebo (índice de riesgo, 0,51; IC del 95 %, 0,34 a 0,77; P = 0,001). El
perfil de seguridad de belimumab fue consistente con el de ensayos
anteriores.
 CONCLUSIONES
En este ensayo en el que participaron pacientes con
nefritis lúpica activa, más pacientes que recibieron
belimumab más el tratamiento estándar de micofenolato
de mofetilo, tuvieron una respuesta renal de eficacia
primaria que aquellos que recibieron el tratamiento
estándar solo.
College Pastel Notes Infographics
 College Pastel Notes Infographics

Mercury
25 % Mercury is the smallest
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Mars is actually a
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Earth
75 % The Earth is the only planet
that harbours life
College Pastel Notes Infographics
College Pastel Notes Infographics

Pluto
It is now considered a
dwarf planet

Jupiter
Jupiter is the biggest
planet of them all
 College Pastel Notes Infographics

02
Mars
Despite being red,

01 Mars is actually a
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Mercury Venus
Mercury is the Venus is cold and is
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 College Pastel Notes Infographics
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Mercury is the Venus has a
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 College Pastel Notes Infographics

Step 1 Step 2 Step 3 Step 4

Mercury Mars Jupiter Venus
Mercury is the Despite being Jupiter is the Venus has a
smallest planet of red, Mars is a biggest planet of beautiful name
them all very cold planet them all but is a hot place
 College Pastel Notes Infographics

Mercury Venus
01 Mercury is the
smallest planet of
them all
Venus has a
beautiful name
but is a hot place
02

Mars Jupiter
03 Despite being
red, Mars is a
very cold planet
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 College Pastel Notes Infographics
Mercury
35 % Mercury is the smallest
planet of them all

Mars
40 % Despite being red, Mars is a
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25 % The Earth is the only planet
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 College Pastel Notes Infographics

A Mercury Venus B
Mercury is the Venus has a
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60 % 40 %
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 College Pastel Notes Infographics

Mercury
Mercury is the smallest 2020
planet of them all

Mars
Despite being red, Mars 2030
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Earth
The Earth is the only 2040
planet with life
 College Pastel Notes Infographics
Mars
1 Despite being red, Mars
is a very cold planet

Mercury Earth
Mercury is the
smallest planet of
them all
2 Earth is the only planet
that harbours life

Venus
3 Venus has a beautiful
name but is a hot place
 College Pastel Notes Infographics

25 % 30 % 45 %

Mercury Mars Venus

Mercury is the Despite being Venus has a
smallest planet of red, Mars is a beautiful name
them all very cold planet but is a hot place
 College Pastel Notes Infographics

Monday Tuesday Wednesday Notes

Neptune is the Mercury is the Venus is the second Planet Earth is the
fourth-largest planet smallest planet in planet from the Sun third planet from the
by diameter the Solar System and is hot Sun

Thursday Friday Weekend

Jupiter is a gas giant Mars is a cold place. Saturn is the gas
and the biggest It’s full of iron giant that has
planet oxide dust several rings
 College Pastel Notes Infographics

30 % 40 %
Mars Mercury
Despite being red, It is the smallest
Mars is a cold planet planet of them all

10 % 20 %
Venus Saturn
Venus is the second Saturn is a gas giant
planet from the Sun with several rings

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 College Pastel Notes Infographics

25 % 20 % 30 % 25 %
Mercury Venus Earth Jupiter
Mercury is the Venus has a Earth is the only Jupiter is the
smallest planet of beautiful name planet that biggest planet of
them all but is a hot place harbours life them all
 College Pastel Notes Infographics

40 % 60 %
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Mercury is the Venus has a
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 College Pastel Notes Infographics

Mercury Venus
Mercury is the Venus has a
smallest planet of beautiful name
them all but is a hot place
Mars
Despite being red,
Mars is a cold place.
It's full of iron oxide
dust what gives the
planet its reddish cast
Earth Jupiter
Earth is the Jupiter is the
only planet that biggest planet of
harbours life them all
 College Pastel Notes Infographics
Mercury Venus
Mercury is the smallest Venus is the second planet
planet of them all from the Sun

Mars Jupiter
Despite being red, Mars Jupiter is a gas giant and
is a very cold planet the biggest planet

Earth Neptune
The Earth is the only Neptune is the fourth-
planet with life largest planet
 College Pastel Notes Infographics

25 %
Mars 50 %
Despite being
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Mercury is the Venus has a Earth is where Jupiter is the
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 College Pastel Notes Infographics

Step 4
Jupiter
Step 3 Jupiter is the
biggest planet
Earth
Step 2 Earth is where
we all live on
Venus
Step 1 Venus has a
beautiful name
Mercury
Mercury is the
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College Pastel Notes Infographics
01
Mercury
Mercury is the smallest planet of them all

02
Venus
Venus is the second planet from the Sun

03
Mars
Despite being red, Mars is a very cold planet

04
Jupiter
Jupiter is a gas giant and the biggest planet

05
Earth
Earth is the only planet that harbours life
 College Pastel Notes Infographics

Test 1 Test 2 Test 3 Test 4 Test 5

Mercury ✓ ✗ ✗ ✗ ✗

Neptune ✗ ✓ ✗ ✓ ✓

Venus ✓ ✗ ✓ ✗ ✗
 College Pastel Notes Infographics

Mercury
Mercury is the
smallest planet of
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Saturn is a gas Despite being
giant with red, Mars is a
several rings very cold planet

Mercury Venus Earth Jupiter

Mercury is the Venus has a Earth is the only Jupiter is the
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them all but is a hot place harbours life them all
 College Pastel Notes Infographics

Mercury Venus Earth

Mercury is the Venus has a Earth is where
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01 02 03
 College Pastel Notes Infographics

Venus Jupiter
Venus has a Jupiter is the
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Mercury is the Earth is the only
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 College Pastel Notes Infographics

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25 %
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Mercury is the
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 College Pastel Notes Infographics
Jupiter Earth
Jupiter is the The Earth is the
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Venus has a Mercury is the
beautiful name smallest planet of
but is a hot place them all
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