scieee Science in your language
[en] (orig)

BioCart© Opinion-based Study on Home Administration Support for Biological Therapies in Patients with Severe Asthma

Author: Delgado Romero, Julio; Soto Retes, Lorena; Cisneros Serrano, Carolina; Blanco Aparicio, Marina; Ferrando Piqueres, Raúl; Díaz Pérez, David; Merino Bohórquez, Vicente
Publisher: Elsevier
Year: 2025
DOI: 10.1016/j.opresp.2024.100375
Source: https://idus.us.es/bitstreams/9c130bbd-2363-4393-8ebc-4e0a43d7720c/download
Open
Respi a o y
A chi es
7
(2025)
100375
Open
Respi a o y
A chi es
www.else ie .es/o a
Scien ific
le e
BioCa ©
Opinion-based
S udy
on
Home
Adminis a ion
Suppo
o
Biological
The apies
in
Pa ien s
wi h
Se e e
As hma
BioCa ©:
Es udio
de
opinión
sob e
el
Apoyo
de
Adminis ación
Domicilia ia
pa a
Te apias
Biológicas
en
Pacien es
con
Asma
G a e
Dea
Edi o ,
In
2022,
he
Spanish
Socie y
o
Alle gology
and
Clinical
Immunology
(SEAIC),
in
collabo a ion
wi h
a
mul idisciplina y
panel
o
expe s
in
he
ea men
o
se e e
as hma
(SA),
de eloped
a
g oundb eaking
ool
o
acili a e
heal hca e
p o essionals
(HCPs)
and
pa ien s
in
managing
hei
as hma
ea men
wi h
biological
he apies
–
BioCa ©
Dia y.1This
ool
was
designed
o
imp o e
pa ien
adhe ence
o
he
sel -adminis a ion
o
biological
he apy
o
SA
in
a
eal-li e
se ing.
P io
s udies
show
ha
poo
he a-
peu ical
adhe ence
nega i ely
a ec s
pa ien ’s
heal h
and
disease
con ol.2–4 The e o e,
a
o mal
educa ion
p og am
and
a
w i en
ac ion
plan
a e
ecommended
o
p e en
as hma
wo sening
and
ensu ing
apid
symp oms
emission.2,3 Hence
he
impo ance
o
ools
like
he
BioCa ©
Dia y
which
p o ides
disease
managemen
in o ma ion,
p ac ical
ips
on
biologics
sel -adminis a ion,
and
se es
as
an
open
communica ion
channel
wi h
HCPs.1In
his
con-
ex ,
his
s udy
e alua es
he
useabili y
and
e ec i eness
o
he
Dia y
in
eal-li e
p ac ice
om
he
pe spec i e
o
pa ien s
and
HCPs.
Eigh
expe s
in
SA
( ou
pulmonologis s
and
ou
alle golo-
gis s)
based
ac oss
Spain
pa icipa ed
in
he
su ey.
Eigh y
wo
pa ien s
wi h
SA
and
unde going
biological
he apy
we e
in i ed
o
use
he
BioCa ©
Dia y
as
pa
o
usual
ollow-up,
and
pa icipa e
in
his
su ey.
Bo h
HCPs
and
SA
pa ien s
comple ed
wo
sel -
adminis e ed
ques ionnai es:
one
be o e
using
he
BioCa ©
Dia y
o
e alua e
expec a ions
o
i s
useabili y
and
u ili y,
and
ano he
a e
6
mon hs,
a ing
he
expe ience
o
i s
use
[PRE
and
POST
ques-
ionnai es
o
HCPs
and
pa ien s
a e
a ailable
as
Supplemen a y
Ma e ial].
Rega ding
e hical
compliance,
his
s udy
is
exemp
om
e hical
commi ee
e alua ion
unde
Spanish
egula ion
bu
com-
plies
wi h
pe sonal
da a
p o ec ion
and
deon ological
codes
o
opinion
su eys.
O
he
82
pa ien s
in i ed,
53
comple ed
bo h
p e-
and
pos -
BioCa ©
use
su eys.
SA
pa ien s,
59%
women
and
41%
men,
had
an
a e age
age
o
54
yea s,
wi h
64%
ha ing
a
SA
diagnosis
o
mo e
han
5
yea s,
81%
using
a
biological
d ug
o
a
leas
1
yea
and
62%
using
a
biological
d ug
a
home
o
a
leas
1
yea
[Supplemen a y
Fig.
2].
The
p e-use
BioCa ©
Dia y
ques ionnai e
e ealed
ha
pa ien s
had
conce ns
abou
when
and
how
o
injec
hei
biological
he apy
a
home,
while
he
HCPs
did
no
pe cei e
hese
as
possible
issues
[Supplemen a y
Fig.
1].
Pa ien s
we e
also
neu al
ega ding
knowl-
edge
abou
he
side
e ec s
o
hei
medica ion
and
how
o
ac
in
esponse
o
hese,
i
necessa y,
while
HCPs
again
did
no
pe cei e
his
as
a
p oblem
[Supplemen a y
Fig.
1].
The
di e ences
in
pe cep-
ions
o
pa ien s
and
HCPs
on
key
issues
such
as
adhe ence
(when
o
injec )
and
aining
(how
o
injec
and
iden i y
ad e se
e en s)
highligh
he
need
o
an
objec i e
ool,
such
as
he
BioCa ©
Dia y,
o
p o ide
in o ma ion
when
needed
and
o
suppo
HCP–pa ien
communica ion.
A e
using
he
BioCa ©
Dia y
o
abou
6
mon hs,
an
e alua ion
o
he
pos -use
ques ionnai e
e ealed
ha
85%
o
pa ien s
used
he
Dia y
as
explained
by
hei
HCP
and
comple ed
all
o
pa
o
he
in o ma ion;
9%
used
i
jus
pa
o
he
ime,
comple ing
all
o
pa
o
he
in o ma ion
and
he
emaining
6%
did
no
use
he
Dia y.
The
main
easons
o
no
comple ing
he
BioCa ©
Dia y
we e
pe sonal
(e.g.,
o ge ing,
lack
o
ime,
using
a
di e en
sys em
o
ack
he
in o ma ion)
[Supplemen a y
Fig.
2].
O e all,
88%
o
HCPs
we e
posi i e
ega ds
he
use
o
he
BioCa ©
Dia y
and
77%
o
pa ien s
a ed
i
as
excellen / e y
good/good;
89%
o
pa ien s
ound
i
easy- o-unde s and
and
79%
ound
he
con en
use ul,
wi h
mos
pa ien s
no
ha ing
any
p oblems
comple ing
i ,
and
he
11%
ha
did
we e
able
o
esol e
hem
sa is ac o ily
by
alking
o
hei
HCP
[Supplemen a y
Fig.
2].
E alua ion
o
he
p e-
and
pos -use
BioCa ©
Dia y
ques ion-
nai es
indica ed
ha
pa ien s
ound
i
easie
o
emembe
injec ing,
adminis e
and
moni o
ea men
when
using
he
Dia y,
i
enabled
mo e
e ec i e
ollow-up
isi s
and
imp o ed
HCP–pa ien
com-
munica ion
(Fig.
1A).
Rega ding
adhe ence,
12%
o
pa ien s
ha e
been
mo e
complian
wi h
he
Dia y,
while
88%
emained
as
com-
plian
as
be o e
[Supplemen a y
Fig.
2].
Based
on
hese
esul s,
HCPs
ound
ha
he
BioCa ©
Dia y
imp o ed
o e all
disease
moni o ing
and
managemen ,
acili a ed
aining
in
he
co ec
sel -adminis a ion
o
biological
he apy,
imp o ed
moni o ing
o
biological
ea men
ad e se
e ec s
and
s eng hened
he
HCP–pa ien
ela ionship
(Fig.
1B).
Howe e ,
as
no
all
pa ien s
esponded
o
he
su ey,
hese
esul s,
al hough
obus ,
may
only
be
ep esen a i e
o
he
mos
comp omised
and
ea men
com-
plian
pa ien s.
The e o e,
ou
esul s
may
no
ep esen
all
ype
o
pa ien s.
O e all,
despi e
no
mee ing
all
expec a ions,
especially
ega d-
ing
he
moni o ing
o
ad e se
e ec s,
HCPs
and
pa ien s
would
ecommend
he
BioCa ©
Dia y
o
o he s,
wi h
mos
HCPs
ha ing
he
opinion
ha
he
Dia y
should
be
gi en
p ima ily
o
pa ien s
abou
o
s a
home
adminis a ion
o
biological
he apy.
I
is
no ewo hy
ha
pa ien s
also
conside ed
he
BioCa ©
Dia y
a
use ul
ool
o
aining
and
sol ing
doub s,
e en
hough
his
was
no
he
ini ial
pu pose
o
he
Dia y,
gi en
he
ele ance
o
co ec
aining
o
he
app op ia e
home
adminis a ion
o
a
bio-
logic
he apy,
BioCa ©
could
ocus
mo e
on
his
di ec ion
in
he
u u e.
h ps://doi.o g/10.1016/j.op esp.2024.100375
2659-6636/©
2024
Sociedad
Espa˜
nola
de
Neumolog´
ıa
y
Ci ug´
ıa
To ´
acica
(SEPAR).
Published
by
Else ie
Espa˜
na,
S.L.U.
This
is
an
open
access
a icle
unde
he
CC
BY-NC-ND
license
(h p://c ea i ecommons.o g/licenses/by-nc-nd/4.0/).
J.
Delgado
Rome o,
L.
So o-Re es,
C.
Cisne os
Se ano
e
al.
Open
Respi a o y
A chi es
7
(2025)
100375
Fig.
1.
U ili y
o
he
BioCa ©
Dia y:
expec a ions
and
eali y
o
(A)
pa ien s
and
(B)
HCPs.
To
he
bes
o
ou
knowledge,
he
BioCa ©
Dia y
is
he
fi s
well-s uc u ed
ool
o
moni o ing
and
suppo ing
he
sel -managemen
o
biological
d ugs
in
SA.
I
acili a es
disease
assessmen
o
bo h
pa ien s
and
HCPs
and
enables
p ecise
con-
ol
o
ea men
adminis a ion
bo h
in
e ms
o
injec ion
si e
and
empo al
acking.
The
BioCa ©
Dia y
assessmen
in
a
eal
clini-
cal
p ac ice
se ing
yielded
e y
posi i e
esul s
es ablishing
i
as
a
use - iendly
and
easy- o-unde s and
Dia y
o
pa ien s
and
HCPs,
highligh ing
he
po en ial
ole
o
ma e ial
such
as
he
BioCa ©
Dia y
o
fill
his
in o ma ion
suppo
gap
in
he
home
adminis a-
ion
o
biological
he apy.
The
u ili y
o
he
BioCa ©
Dia y
migh
be
u he
imp o ed
by
collec ing
mo e
da a
o e
longe
pe iods
o
ime
and
making
i
accessible
ia
a
websi e
o
an
applica ion.
The
jou ney
o
he
BioCa ©
Dia y
is
p omising
and
is
expec ed
o
ha e
a
posi i e
impac
o
pa ien s
wi h
SA
and
on
biological
he apy.
In o med
consen
Pa icipan s
exp essed
hei
consen
o
pa icipa e
in
his
opinion
s udy
by
accep ing
a
pa icipa ion
clause
de ailing
he
pu pose
o
he
s udy
and
he
p ocessing
o
pe sonal
da a.
The
exac
pa icipa ion
clauses
a e
de ailed
in
he
Supplemen a y
Ma e ial
PRE&POST
su ey
pa ien .
Funding
This
p ojec
is
he
esul
o
a
collabo a ion
be ween
GSK
and
he
Spanish
Socie y
o
Alle gology
and
Clinical
Immunology
(SEAIC)
and
was
unded
by
GSK.
Au ho s’
con ibu ions
All
au ho s
ha e
equally
con ibu ed
o
he
concep ion,
design,
analysis,
and
in e p e a ion
o
he
p esen
wo k.
Fu he ,
all
au ho s
ha e
con ibu ed
o
d a ing
o
c i ically
e ising
his
manusc ip ,
ha e
app o ed
he
final
e sion
and
ag ee
wi h
i s
submission
o
Jou nal
o
In es iga ional
Alle gology
&
Clinical
Immunology.
All
au ho s
a e
accoun able
o
all
aspec s
o
he
wo k
and
in
ensu ing
ha
ques ions
ela ed
o
he
accu acy
o
in eg i y
o
any
pa
o
he
wo k
a e
app op ia ely
in es iga ed
and
esol ed.
Conflic s
o
in e es
GSK
unded
Adelphi
Ta gis
who
a anged
expe
mee ings
and
p o ided
MW
suppo
(including
assis ing
au ho s
wi h
he
de el-
opmen
o
he
ini ial
d a
and
inco po a ion
o
commen s),
and
edi o ial
suppo
(including
figu e
p epa a ion,
o ma ing,
p oo -
eading
and
submission),
unde
he
di ec ion
and
guidance
o
he
expe
au ho s,
acco ding
o
Good
Publica ion
P ac ice
guidelines
(GPP
2022).
GSK
had
an
oppo uni y
o
p o ide
commen s
o
he
2
J.
Delgado
Rome o,
L.
So o-Re es,
C.
Cisne os
Se ano
e
al.
Open
Respi a o y
A chi es
7
(2025)
100375
au ho s
o
hei
conside a ion.
The
au ho s
we e
solely
esponsible
o
opinions,
c i ical
assessmen
and
in e p e a ion,
and
app o ed
he
final
con en .
Julio
Delgado
Rome o
also
decla es
he
ollowing
conflic
o
in e es s:
ecei ed
consul ing
ees
om
As aZeneca
and
hono-
a ia
om
As aZeneca,
Sanofi,
and
GSK
o
lec u es,
p esen a ions,
speake s’
bu eaus,
manusc ip
w i ing
and
educa ional
e en s.
Lo ena
So o-Re es
also
decla es
ha
she
has
ecei ed
hono-
a ia
om
As aZeneca,
Sanofi,
and
GSK
o
lec u es,
p esen a ions,
speake s’
bu eaus,
manusc ip
w i ing
and
educa ional
e en s.
Also
g an s
o
a ending
mee ings
and/o
a el
om
HAL
Alle gy
S.L.U.,
As aZeneca,
and
Sanofi.
Ca olina
Cisne os
Se ano
also
epo s
ha
she
has
ecei ed
con-
sul ing
ees
om
GSK,
No a is,
As aZeneca,
and
Sanofi.
She
has
also
ecei ed
paymen
o
hono a ia
o
lec u es
om
Labo a o ios
Geb o
Pha ma
S.A.,
GSK,
As aZeneca,
Chiesi,
Sanofi
and
No a -
is.
She
has
ecei ed
suppo
o
a ending
mee ings
and/o
a el
om
Sanofi
As aZeneca,
Chiesi,
and
Labo a o ios
Geb o
Pha ma
S.A.
She
has
pa icipa ed
on
a
Da a
Sa e y
Moni o ing
Boa d
o
Ad iso y
Boa d
o
GSK,
As aZeneca,
No a is,
and
Sanofi.
Finally,
she
has
ecei ed
equipmen
o
ma e ials
om
GSK,
Sanofi,
and
As aZeneca.
Ma ina
Blanco
Apa icio
epo s
ha
she
has
no
o he
conflic s
o
in e es s
aside
om
he
paymen
ecei ed
om
GSK
o
pa icipa e
in
he
BioCa ©
S udy.
Raúl
Fe ando
Pique es
epo s
ha
he
has
no
o he
conflic s
o
in e es s
aside
om
he
paymen
ecei ed
om
GSK
o
pa icipa e
in
he
BioCa ©
S udy.
Da id
Díaz-Pé ez
decla es
ha
he
has
also
ecei ed
hono-
a ia
om
As aZeneca,
Chiesi,
Sanofi,
GSK,
TEVA
Pha maceu icals
and
Boeh inge
Ingelheim
o
lec u es,
p esen a ions,
speake s’
bu eaus,
manusc ip
w i ing
and
educa ional
e en s.
Valen ín
López
Ca asco
decla es
ha
he
has
also
ecei ed
hon-
o a ia
o
lec u es,
p esen a ions,
speake s’
bu eaus,
manusc ip
w i ing
o
educa ional
e en s
om
GSK,
TEVA
Pha maceu icals,
As aZeneca,
Chiesi
and
Sanofi.
Vicen e
Me ino
Bóho quez
also
decla es
ha
he
has
ecei ed
hono a ia
om
As aZeneca,
GSK,
Sanofi
and
No a is
o
lec u es,
p esen a ions,
speake s’
bu eaus,
manusc ip
w i ing
and
educa-
ional
e en s.
Also
g an s
o
a ending
mee ings
and/o
a el
om
As aZeneca,
GSK,
Sanofi,
and
No a is.
He
has
also
ecei ed
ees
o
pa icipa ing
on
Da a
Sa e y
Moni o ing
Boa d
o
Ad iso y
Boa d
om
As aZeneca,
GSK,
Sanofi,
and
No a is.
Ja ie
Domínguez
O ega
also
epo s
consul ing
ees
om
GSK
and
As aZeneca.
He
has
also
ecei ed
hono a ia
om
ALK-
Abelló
A/S,
As aZeneca,
Sanofi,
GSK,
Chiesi,
LETI
Pha ma
and
TEVA
Pha maceu icals
o
lec u es,
p esen a ions,
speake s’
bu eaus,
manusc ip
w i ing
and
educa ional
e en s.
Acknowledgmen s
We
would
like
o
hank
he
eigh
se e e
as hma
expe s
who
pa icipa ed
in
he
P ojec
as
well
as
hei
espec i e
pa ien s
as
hei
opinions
con ibu ed
o
he
imp o emen
o
he
BioCa ©
ool;
Alle gis s:
Ma
Fe nández
Nie o
(H.U.
Fundación
Jiménez
Díaz),
C is ina
Ma in
Ga cía
(H.C.U.
o
Salamanca),
Ma ía
Rubio
Pé ez
(H.
In an a
So ía),
Ma ía
Vázquez
de
la
To e
Gaspa
(H.U.
In an a
Leono );
Pulmonologis s:
MaCleo é
Fe nández
A acil
(H.G.U.
Ali-
can e),
Tama a
He mida
Val e de
(H.C.U.
o
As u ias),
Inmaculada
Lluch
To ajada
(H.U.
de
la
Ribe a)
and
G ego io
So o
Campos
(H.U.
o
Je ez).
To
Bea iz
Velasco-Lao ga
om
GlaxoSmi hKline
(GSK)
o
he
suppo
o
ca y
ou
his
p ojec
and
he
manusc ip .
To
he
s a egic
consul ancy
eam
o
Adelphi
Ta gis
S.L.,
com-
p ised
o
Ana
Fe nández
and
Ne ea
To o,
o
hei
echnical
and
edi o ial
suppo
a
de eloping
he
BioCa ©
Dia y
s udy.
Appendix
A.
Supplemen a y
da a
Supplemen a y
da a
associa ed
wi h
his
a icle
can
be
ound
in
he
online
e sion
a ailable
a
h ps://doi.o g/10.1016/
j.op esp.2024.100375.
Re e ences
1.
Delgado
Rome o
J,
Blanco-Apa icio
M,
Cisne os
Se ano
C,
Díaz-Pé ez
D,
Fe ando
Pique es
R,
López-Ca asco
V,
e
al.
Suppo
o
home
adminis a ion
o
biolog-
ical
he apy
in
pa ien s
wi h
se e e
as hma:
BioCa ©.
J
In es ig
Alle gol
Clin
Immunol.
2022;32:482–4,
h p://dx.doi.o g/10.18176/jiaci.0786.
2.
Plaza
V,
Alobid
I,
Al a ez
C,
Blanco
M,
Fe ei a
J,
Ga cía
G,
e
al.
Spanish
As hma
Managemen
Guidelines
(GEMA)
VERSION
5.1.
Highligh s
and
con o e sies.
A ch
B onconeumol.
2022;58:150–8,
h p://dx.doi.o g/10.1016/j.a b es.2021.05.010.
3.
Cisne os-Se ano
C,
Rial
MJ,
Gómez-Bas e o-Fe nández
A,
Igea
JM,
Ma ínez-
Meca
A,
Fe nández-Lisón
LC,
e
al.
Spanish
mul idisciplina y
consensus
on
he
cha ac e is ics
o
se e e
as hma
pa ien s
on
biologic
ea men
who
a e
candida es
o
a -home
adminis a ion.
Re
Clin
Esp.
2023;223:154–64,
h p://dx.doi.o g/10.1016/j. ceng.2022.11.008.
4.
González
Ba cala
FJ,
de
la
Fuen e-Cid
R,
Ál a ez-Gil
R,
Ta alla
M,
Nue o
J,
Caama˜
no-Iso na
F.
Fac o s
associa ed
wi h
as hma
con ol
in
p ima y
ca e
pa ien s:
he
CHAS
s udy.
A ch
B onconeumol.
2010;46:358–63,
h p://dx.doi.o g/10.1016/j.a b es.2010.01.007.
Julio
Delgado
Rome oa,j,∗,
Lo ena
So o-Re esb,c,j,
Ca olina
Cisne os
Se anod,
Ma ina
Blanco-Apa icioe,
Raúl
Fe ando
Pique es ,
Da id
Díaz-Pé ezg,
Valen ín
López-Ca ascoh,j,
Vicen e
Me ino-Bohó quezi,
Ja ie
Domínguez-O egah,j
aDepa men
o
Alle gology,
Hospi al
Vi gen
Maca ena,
Se ille,
Spain
bDepa men
o
Pneumology
and
Alle gy,
Hospi al
de
la
San a
C eu
i
San
Pau,
Ba celona,
Spain
cIns i u e
o
Biomedical
Resea ch
San
Pau
(IIB
San
Pau),
Ba celona,
Spain
dDepa men
o
Pneumology,
Hospi al
Uni e si a io
La
P incesa,
Mad id,
Spain
ePneumology
Se ice,
Hospi al
Uni e si a io
da
Co u˜
na,
A
Co u˜
na,
Spain
Pha macy
Depa men ,
Hospi al
Gene al
Uni e si a io
Cas ellón,
Cas ellón,
Spain
gHospi al
Uni e si a io
Nues a
Se˜
no a
de
Candela ia,
Unidad
de
In es igación
CHUNSC/GAPTF,
San a
C uz
de
Tene i e,
Spain
hDepa men
o
Alle gology,
Hospi al
Uni e si a io
La
Paz
III-Can oblanco,
Ins i u e
o
Heal h
Resea ch
(IdiPAZ),
Mad id,
Spain
iPha macy
Depa men ,
Hospi al
Uni e si a io
Vi gen
Maca ena,
Se ille,
Spain
jSpanish
Socie y
o
Alle gology
and
Clinical
Immunology
(SEAIC),
Spain
∗Co esponding
au ho .
E-mail
add ess:
[email p o ec ed]
(J.
Delgado
Rome o).
3