Persistence, effectiveness and safety of ustekinumab compared to TNF inhibitors in psoriatic arthritis within the Italian PsABio cohort
Elisa Gremese
(1, 2)
,
Francesco Ciccia
(3)
,
Carlo Selmi
(4)
,
Giovanna Cuomo
(5)
,
Rosario Foti
,
Marco Matucci-Cerinic
(6)
,
Fabrizio Conti
(7)
,
Enrico Fusaro
,
Giuliana Guggino
(8)
,
Florenzo Iannone
(9)
,
Andrea Delle Sedie
(10)
,
Roberto Perricone
(11)
,
Luca Idolazzi
,
Paolo Moscato
,
Elke Theander
(12)
,
Wim Noël
(13)
,
Paul Bergmans
(12)
,
Silvia Marelli
(14)
,
Laure Gossec
(15)
,
Josef Smolen
(16)
1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2 Unicatt - Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma]
3 University of the Study of Campania Luigi Vanvitelli
4 IRCCS - Istituti di Ricovero e Cura a Carattere Scientifico
5 Azienda Ospedaliera Careggi
6 UniFI - Università degli Studi di Firenze = University of Florence = Université de Florence
7 UNIROMA - Università degli Studi di Roma "La Sapienza" = Sapienza University [Rome]
8 Università degli studi di Palermo - University of Palermo
9 UNIBA - Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro
10 University of Pisa - Università di Pisa
11 University of Rome TorVergata
12 Janssen Research & Development
13 University of Oxford
14 Internal Combustion Engines Group (ICEG)
15 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
16 Medizinische Universität Wien = Medical University of Vienna
2 Unicatt - Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma]
3 University of the Study of Campania Luigi Vanvitelli
4 IRCCS - Istituti di Ricovero e Cura a Carattere Scientifico
5 Azienda Ospedaliera Careggi
6 UniFI - Università degli Studi di Firenze = University of Florence = Université de Florence
7 UNIROMA - Università degli Studi di Roma "La Sapienza" = Sapienza University [Rome]
8 Università degli studi di Palermo - University of Palermo
9 UNIBA - Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro
10 University of Pisa - Università di Pisa
11 University of Rome TorVergata
12 Janssen Research & Development
13 University of Oxford
14 Internal Combustion Engines Group (ICEG)
15 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
16 Medizinische Universität Wien = Medical University of Vienna
Rosario Foti
- Fonction : Auteur
Enrico Fusaro
- Fonction : Auteur
Luca Idolazzi
- Fonction : Auteur
Paolo Moscato
- Fonction : Auteur
Résumé
Objective. To compare real-world persistence, effectiveness and tolerability of ustekinumab versus TNF inhibitors (TNFi) in psoriatic arthritis (PsA).
Methods. One-year data from Italian subjects enrolled in the PsABio study (PsA patients receiving 1st- to 3rd-line treatment with ustekinumab or TNFi) were evaluated. Treatment persistence was analysed using Kaplan-Meier curves; hazard ratios (HR) of stopping treatment, and the corresponding 95% confidence intervals (CI), were computed through Cox regression models. Proportions of patients reaching clinical effectiveness endpoints were analysed using logistic regression, including propensity score (PS) adjustment for imbalanced baseline covariates, and non-response imputation if treatment was stopped/switched.
Results. Among 222 participants with follow-up data (effectiveness set), 101 received ustekinumab and 121 TNFi. In the ustekinumab group, 74.3% continued treatment up to 12±3 months compared to 63.6% in the TNFi group. Ustekinumab showed better persistence than TNFi, overall and in specific subgroups (females, monotherapy without methotrexate, BMI <25 or >30 kg/m2, patients receiving ustekinumab as 2nd-line treatment instead of a second TNFi). Overall, the PS-adjusted HR of treatment discontinuation was 0.46 (95% CI: 0.26-0.82) for ustekinumab vs TNFi. cDAPSA LDA/remission was achieved in 43.5% of ustekinumab and 43.6% of TNFi-treated patients, while MDA was achieved in 24.2% and 28.0% of patients, respectively. After PS adjustment, odds ratios of clinical effectiveness did not differ significantly. Both treatments showed an acceptable safety profile.
Conclusion. This prospective, real-life study found a better persistence of ustekinumab than TNFi in PsA patients. At 1 year, both treatments showed similar effectiveness.
Domaines
Sciences du Vivant [q-bio]Format du dépôt | Fichier |
---|---|
Type de dépôt | Article dans une revue |
Titre |
en
Persistence, effectiveness and safety of ustekinumab compared to TNF inhibitors in psoriatic arthritis within the Italian PsABio cohort
|
Résumé |
en
Objective. To compare real-world persistence, effectiveness and tolerability of ustekinumab versus TNF inhibitors (TNFi) in psoriatic arthritis (PsA).
Methods. One-year data from Italian subjects enrolled in the PsABio study (PsA patients receiving 1st- to 3rd-line treatment with ustekinumab or TNFi) were evaluated. Treatment persistence was analysed using Kaplan-Meier curves; hazard ratios (HR) of stopping treatment, and the corresponding 95% confidence intervals (CI), were computed through Cox regression models. Proportions of patients reaching clinical effectiveness endpoints were analysed using logistic regression, including propensity score (PS) adjustment for imbalanced baseline covariates, and non-response imputation if treatment was stopped/switched.
Results. Among 222 participants with follow-up data (effectiveness set), 101 received ustekinumab and 121 TNFi. In the ustekinumab group, 74.3% continued treatment up to 12±3 months compared to 63.6% in the TNFi group. Ustekinumab showed better persistence than TNFi, overall and in specific subgroups (females, monotherapy without methotrexate, BMI <25 or >30 kg/m2, patients receiving ustekinumab as 2nd-line treatment instead of a second TNFi). Overall, the PS-adjusted HR of treatment discontinuation was 0.46 (95% CI: 0.26-0.82) for ustekinumab vs TNFi. cDAPSA LDA/remission was achieved in 43.5% of ustekinumab and 43.6% of TNFi-treated patients, while MDA was achieved in 24.2% and 28.0% of patients, respectively. After PS adjustment, odds ratios of clinical effectiveness did not differ significantly. Both treatments showed an acceptable safety profile.
Conclusion. This prospective, real-life study found a better persistence of ustekinumab than TNFi in PsA patients. At 1 year, both treatments showed similar effectiveness.
|
Auteur(s) |
Elisa Gremese
1, 2
, Francesco Ciccia
3
, Carlo Selmi
4
, Giovanna Cuomo
5
, Rosario Foti
, Marco Matucci-Cerinic
6
, Fabrizio Conti
7
, Enrico Fusaro
, Giuliana Guggino
8
, Florenzo Iannone
9
, Andrea Delle Sedie
10
, Roberto Perricone
11
, Luca Idolazzi
, Paolo Moscato
, Elke Theander
12
, Wim Noël
13
, Paul Bergmans
12
, Silvia Marelli
14
, Laure Gossec
15
, Josef Smolen
16
1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
( 543380 )
- Largo Agostino Gemelli, 8, 00168 Roma
- Italie
2
Unicatt -
Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma]
( 331195 )
- Largo Francesco Vito, 1,
00168 Roma
- Italie
3
University of the Study of Campania Luigi Vanvitelli
( 1059099 )
- Italie
4
IRCCS -
Istituti di Ricovero e Cura a Carattere Scientifico
( 363961 )
- Italie
5
Azienda Ospedaliera Careggi
( 245064 )
- 3, Lg. Brambilla - 50134 Firenze
- Italie
6
UniFI -
Università degli Studi di Firenze = University of Florence = Université de Florence
( 148408 )
- Piazza di San Marco, 4, 50121 Firenze FI, Italie
- Italie
7
UNIROMA -
Università degli Studi di Roma "La Sapienza" = Sapienza University [Rome]
( 229915 )
- Piazzale Aldo Moro 5, 00185 Roma
- Italie
8
Università degli studi di Palermo - University of Palermo
( 302329 )
- Italie
9
UNIBA -
Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro
( 300766 )
- Piazza Umberto I - 70121 Bari
- Italie
10
University of Pisa - Università di Pisa
( 366408 )
- Lungarno Pacinotti 43 - 56126 Pisa
- Italie
11
University of Rome TorVergata
( 490368 )
- Italie
12
Janssen Research & Development
( 486606 )
- 1125 Trenton-Harbourton Road
Titusville, NJ 08560
- États-Unis
13
University of Oxford
( 302612 )
- Wellington Square, Oxford OX1 2JD
- Royaume-Uni
14
Internal Combustion Engines Group (ICEG)
( 247595 )
- Italie
15
iPLESP -
Institut Pierre Louis d'Epidémiologie et de Santé Publique
( 542132 )
- 56, boulevard Vincent Auriol - CS 81393 - 75646 Paris Cedex 13
- France
16
Medizinische Universität Wien = Medical University of Vienna
( 93275 )
- Spitalgasse 23, A-1090 Vienna
- Autriche
|
Langue du document |
Anglais
|
Nom de la revue |
|
Vulgarisation |
Non
|
Comité de lecture |
Oui
|
Audience |
Internationale
|
Date de publication |
2022
|
Domaine(s) |
|
Mots-clés |
en
Persistence, Effectiveness, Safety, Observational studies, TNF Inhibitors, Ustekinumab, Psoriatic Arthritis
|
DOI | 10.55563/clinexprheumatol/j33pjt |
Origine :
Fichiers produits par l'(les) auteur(s)
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