Manhattan Study: Observational, Ambispective Study to Describe Persistence and Effectiveness of a Second-line Guselkumab or TNF Inhibitors After First-line TNF Inhibitors for the Treatment of Active Psoriatic Arthritis in Spain

María Rocío González Molina¹, C Marín Huertas², B Joven-Ibáñez³, L de Prado⁴, Lourdes Mateo⁵, M Llanes Gómez⁶, A Hernández del Río⁷, EA Blanco-Morales⁸, J Malavé Calzada⁹, Meritxell Sallés Lizarzaburu¹⁰, Inmaculada Ros-Vilamajó¹¹, Martina Steiner¹², EVELIN CERVANTES PEREZ¹³, Vanesa Hernández-Hernández¹⁴, S Castro Oreiro¹⁵, ANA URRUTICOECHEA¹⁶, L Orpinell Palacio¹⁷, J Campos Esteban¹⁸, Raúl Veroz González¹⁹, O Camacho Alcázar²⁰, MP Moreno-Gil²¹, A Aragón Díez²², MJ Moreno-Ramos²³, FJ Maceiras Pan²⁴, S Díaz-Castroverde²⁵, Santiago Muñoz Fernández²⁶, JA Pinto Tasende²⁷ and J Ramírez García²⁸, ¹Hospital Reina Sofía, Murcia, Murcia, Spain, ²Hospital Infanta Leonor, Madrid, Madrid, Spain, ³Hospital Universitario 12 de Octubre, Madrid, Madrid, Spain, ⁴Hospital de Mollet, Mollet del Vallès, Barcelona, Catalonia, Spain, ⁵H Germans Trias i Pujol, Barcelona, Spain, ⁶Hospital Juan Ramón Jiménez, Huelva, Andalucia, Spain, ⁷Hospital Naval, Ferrol, A Coruña, Galicia, Spain, ⁸Hospital Virgen del Rocío, Sevilla, Andalucia, Spain, ⁹Hospital Virgen del Puerto, Plasencia, Cáceres, Extremadura, Spain, ¹⁰Althaia Xarxa Assistencial Universitària Manresa, Manresa, Catalonia, Spain, ¹¹Hospital Universitari Son Llàtzer, Palma de Mallorca, Islas Baleares, Spain, ¹²Department of Rheumatology. Hospital Universitario Infanta Sofía., Madrid, Spain, ¹³Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Galicia, Spain, ¹⁴Hospital Universitario de Canarias, San Cristobal de La Laguna, Canarias, Spain, ¹⁵Hospital Sant Joan XXIII, Tarragona, Catalonia, Spain, ¹⁶Hospital Universitario Son Espases, Palma de Mallorca, Islas Baleares, Spain, ¹⁷Hospital Sagrat Cor, Barcelona, Spain, ¹⁸Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain, ¹⁹Hospital Mérida, Badajoz, Spain, ²⁰Hospital Sant Joan Despí Moisès Broggi, Sant Joan Despí, Barcelona, Catalonia, Spain, ²¹Hospital San Pedro de Alcántara, Cáceres, Extremadura, Spain, ²²Hospital Universitario de Getafe, Getafe, Madrid, Madrid, Spain, ²³Hospital Virgen de Arrixaca, Murcia, Murcia, Spain, ²⁴Hospital de Meixoeiro, Pontevedra, Galicia, Spain, ²⁵Johnson&Johnson Innovative Medicine, Madrid, Madrid, Spain, ²⁶Hospital Universitario Infanta Sofía. Universidad Europea de Madrid, Madrid, Spain, ²⁷Complejo Hospitalario Universitario, A Coruña, Spain, ²⁸Hospital Clínic, Barcelona, Spain

Meeting: ACR Convergence 2024

Keywords: Biologicals, Psoriatic arthritis

Session Information

Date: Sunday, November 17, 2024

Title: SpA Including PsA – Treatment Poster II

Session Type: Poster Session B

Session Time: 10:30AM-12:30PM

Background/Purpose: PsA is a complex inflammatory condition affecting both the skin and musculoskeletal system. Clinical guidelines recommend biological therapies after conventional synthetic DMARDs (csDMARDs) inadequate response or intolerance. However, limited information has been published about biological therapies sequencing in clinical practice in terms of effectiveness and survival. Manhattan study aims to describe the effectiveness of guselkumab (GUS) or a second-line TNF inhibitor (TNFi) after receiving a first-line TNFi.

Methods: Manhattan (CNTO1959PSA4009) is an ongoing ambispective, observational cohort, study of patients with PsA in 34 hospitals in Spain. The study is evaluating effectiveness, persistence and tolerability of second-line GUS or TNFi patients after receiving a first-line TNFi treatment. An interim analysis was performed 10 months after the inclusion of the first patient. Sixty-nine participants (GUS n=36, TNFi n=33) had data available at week 12 and 56.5% (GUS n=25, TNFi n=14) at week 24, the maximum follow-up period in this analysis.

Results: Baseline clinical and demographic characteristics were described among all included patients for GUS and TNFi group, respectively. The mean age at PsA diagnosis was 42.8 for both groups, similar mean BMI was described (27.6 kg/m² GUS and 29.3 kg/m² TNFi) with 55.6% and 45.5% of females in GUS and TNFi group, respectively. The predominance of PsA characteristics were described for GUS and TNFi respectively: polyarticular PsA (63.9%, 78.1%); oligoarticular PsA (30.6%, 21.2%); mean Tender Joint Count (TJC) (5.7, 4.8); mean Swollen Joint Count (SJC) (3.5, 2.9); enthesitis (25.0%, 34.4%); dactylitis (19.4%, 12.5%); nail psoriasis (38.9%, 36.4%) and active psoriasis (66.7%, 45.5%). Concomitant csDMARDs at second-line were used in 38.9% of GUS patients and 51.5% of TNFi patients.

The percentage of patients with Disease Activity in Psoriatic Arthritis (DAPSA) Low Disease Activity (LDA) (≤ 14) increased over the time in both groups. After 24 weeks, 77.8% GUS patients and 69.2% TNFi patients were in DAPSA LDA (Figure 1). Accordingly, number of TJC and SJC were decreased over the time in both groups (Figure 2). Despite the baseline mean Body Surface Area (BSA) of 5.5% for GUS patients (Figure 3), 86.2% of patients had BSA ≤ 3% at week 12.

After 24 weeks, 95.7% of patients were still treated with GUS (1 patient suspended for patient desire) and 78.3% with TNFi (3 patient suspended due to adverse events and 1 due to primary failure).

One adverse drug reaction (ADR) was reported for GUS patients (headache) and four for TNFi patients (upper respiratory tract infection, syncope, alopecia, and skin reaction). No severe ADR was reported.

Conclusion: Among patients included in this interim analysis, DAPSA LDA was reached similarly after 24 weeks GUS or TNFi treatment whereas the probability of persistence to treatment was slightly higher in the GUS group.

Disclosures: M. González Molina: None; C. Marín Huertas: None; B. Joven-Ibáñez: AbbVie/Abbott, 2, 6, Amgen, 6, Bristol-Myers Squibb(BMS), 2, 5, Eli Lilly, 5, 6, Janssen, 2, 6, Novartis, 2, 6, UCB, 6; L. de Prado: AstraZeneca, 6, Janssen, 12, collaborating researcher in a clinical trial; L. Mateo: None; M. Llanes Gómez: None; A. Hernández del Río: None; E. Blanco-Morales: None; J. Malavé Calzada: None; M. Sallés Lizarzaburu: None; I. Ros-Vilamajó: None; M. Steiner: None; E. CERVANTES PEREZ: None; V. Hernández-Hernández: None; S. Castro Oreiro: None; A. URRUTICOECHEA: AbbVie/Abbott, 6, Amgen, 6, Galápagos, 6, GlaxoSmithKlein(GSK), 1, Janssen, 6, Lilly, 6, Novartis, 1, UCB, 6; L. Orpinell Palacio: None; J. Campos Esteban: Janssen, 6; R. Veroz González: None; O. Camacho Alcázar: None; M. Moreno-Gil: None; A. Aragón Díez: None; M. Moreno-Ramos: None; F. Maceiras Pan: None; S. Díaz-Castroverde: Janssen, 3; S. Muñoz Fernández: AbbVie/Abbott, 1, 6, AstraZeneca, 5, GlaxoSmithKlein(GSK), 5, Janssen, 1, 2, 6, Novartis, 5, UCB, 6; J. Pinto Tasende: AbbVie/Abbott, 1, 6, Amgen, 1, 6, Bristol-Myers Squibb(BMS), 6, Eli Lilly, 6, Janssen, 1, 6, Novartis, 1, 6; J. Ramírez García: None.

To cite this abstract in AMA style:

González Molina M, Marín Huertas C, Joven-Ibáñez B, de Prado L, Mateo L, Llanes Gómez M, Hernández del Río A, Blanco-Morales E, Malavé Calzada J, Sallés Lizarzaburu M, Ros-Vilamajó I, Steiner M, CERVANTES PEREZ E, Hernández-Hernández V, Castro Oreiro S, URRUTICOECHEA A, Orpinell Palacio L, Campos Esteban J, Veroz González R, Camacho Alcázar O, Moreno-Gil M, Aragón Díez A, Moreno-Ramos M, Maceiras Pan F, Díaz-Castroverde S, Muñoz Fernández S, Pinto Tasende J, Ramírez García J. Manhattan Study: Observational, Ambispective Study to Describe Persistence and Effectiveness of a Second-line Guselkumab or TNF Inhibitors After First-line TNF Inhibitors for the Treatment of Active Psoriatic Arthritis in Spain [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/manhattan-study-observational-ambispective-study-to-describe-persistence-and-effectiveness-of-a-second-line-guselkumab-or-tnf-inhibitors-after-first-line-tnf-inhibitors-for-the-treatment-of-active-p/. Accessed .

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