Failure Predictors to Anti-Tumor Necrosis Antagonists in Patients with Chronic Arthritis: Results of a National Registry Biobadasar

Maria Jezabel Haye Salinas¹, Soledad Retamozo², Alejandro Alvarellos³, Francisco Caeiro⁴, Juan Pablo Pirola⁴, Diego Baenas¹, María Celina de La Vega⁵, Gustavo Casado⁶, Gimena Gomez⁷, Javier Roberti⁸, Osvaldo Luis Cerda⁹, Ignacio Javier Gandino¹⁰, Ana Quinteros¹¹, Ida Exeni^6,12, Juan Manuel Bande¹³, Juan Carlos Barreira¹⁴, Carla Gobbi¹⁵, Analia Alvarez¹⁶, Amelia Granel¹⁷, Alejandra Peluzzon¹⁸, Ana Capuccio¹⁹, Romina Nieto²⁰, Rossana Quintana²¹, Eduardo Mussano²², Santiago Scarafia²³, Carolina Costi²⁴, Mercedes De La Sota²⁵, Monica Patricia Diaz²⁶, Edson Javier Velozo²⁷, Santiago Aguero²⁸, Cristina Battagliotti²⁹, Sidney Soares de Souza³⁰, Emilia Cavillon³¹, Analia Bohr³², Andrea Smichowski³³, Daniela Vidal³⁴, Dora Pereira³⁵, Liliana Martinez³⁶, Luis Somma³⁷, Marta Zalazar³⁸, Pablo Finucci Curi³⁹, Leandro Carlevaris⁴⁰, Guillermo Berbotto⁴¹ and Veronica Saurit⁴, ¹Hospital Privado Centro Médico de Córdoba, Córdoba, Argentina, ²Rheumatology Unit, Hospital Privado Centro Médico de Córdoba, Argentina, Córdoba, Argentina, ³Rheumatology, Hospital Privado Centro Médico de Córdoba, Cordoba, Argentina, ⁴Rheumatology, Hospital Privado Centro Médico de Córdoba, Córdoba, Argentina, ⁵Sociedad Argentina de Reumatología, CABA, Argentina, ⁶Sociedad Argentina de Reumatologia, CABA, Argentina, ⁷Sociedad Argentina de Reumatología, Buenos Aires, Argentina, ⁸SAR, CABA, Argentina, ⁹IREP, CABA, Argentina, ¹⁰Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ¹¹Centro Integral Reumatológico, Tucuman, Argentina, ¹²Sanatorio Parque, Cordoba, Argentina, ¹³Hospital Tornú, CABA, Argentina, ¹⁴Rheumatology Unit, Hospital Britanico de Buenos Aires, CABA, Argentina, ¹⁵Rheumatology, Sanatorio Allende de Córdoba, Cordoba, Argentina, ¹⁶Hospital Penna, Bahía Blanca, Argentina, ¹⁷Centro Platense de Reumatología, La Plata, Argentina, ¹⁸Hospital Clínica José de San Martín, CABA, Argentina, ¹⁹Hospital Cesar Milstein, CABA, Argentina, ²⁰Hospital Provincial, Rosario, Argentina, ²¹Sanatorio Parque, Rosario, Argentina, ²²Córdoba, Hospital Nacional de Clínicas, Córdoba, Argentina, ²³Hospital Bernardino Rivadavia, CABA, Argentina, ²⁴Hospital San Martín, LaPlata, Argentina, ²⁵Consultorios, Bahia Blanca, Argentina, ²⁶Hospital Zonal Bariloche, Bariloche, Argentina, ²⁷Rheumatology, Sanatorio Adventista del Plata, Entre Rios, Argentina, ²⁸Sanatorio Pasteur, Catamarca, Argentina, ²⁹Hospital de Niños Dr Orlando Alasia, Santa Fé, Argentina, ³⁰Ramallo 1851, REUMAR, CABA, Argentina, ³¹Consultorio, Cordoba, Argentina, ³²Hospital de Rehabilitación Rocca, CABA, Argentina, ³³Atención Integral de Reumatología, CABA, Argentina, ³⁴Hospital de Niños de Córdoba, Córdoba, Argentina, ³⁵Centro Raquis, Buenos Aires, Argentina, ³⁶Hospital Fernandez, CABA, Argentina, ³⁷SOMMA, Buenos Aires, Argentina, ³⁸Hospital Pirovano, CABA, Argentina, ³⁹Centro Médico Mitre, Entre Rios, Argentina, ⁴⁰IARI, CABA, Argentina, ⁴¹Sanatorio Británico, Rosario, Argentina

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Adverse events, arthritis management and biologic response modifiers, Biologic agents, Effective

Session Information

Date: Sunday, November 13, 2016

Title: Epidemiology and Public Health - Poster I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: to analyze failure predictors to anti-tumor necrosis (TNF) therapy in patients who have switched these drugs during chronic arthritis treatment.

Methods: BIOBADASAR is a national registry from Argentina. Patients with Autoimmune Rheumatic Diseases are included with appropriate diagnostic criteria and different forms of chronic arthritis who are treatment with biological drugs (bDMARDs). A control population matched for diagnosis and demographic features, free of bDMARDs therapy is included. Using this registry, we have analyzed patient switching of TNF antagonists. The log-rank test was used to compare survival curves, and Cox regression models were used to assess independent factors associated with discontinuing medication.

Results: From August 2010 to January 2016, 3397 patients were registered with: RA 2745 (78.6%), PsA 395 (11.3%), JIA 150 (4.3%), AS 107 (3.07%); mean age: 57.1±14.8 yrs; 78.4% female. 1853/3397(54,5%) patients received a total of 2079 treatment cycles: Etanercept (ETA) was used in 1155 (55.6%), adalimumab (ADA) in 601 (28.9%), infliximab (INF) in 156 (7.5%), certolizumab in 118 (5.7%) and golimumab in 49 (2.4%). More than one anti TNF was used in 1520/1853 (82%) patients. The median survival time of TNF antagonists was 36 (range, 1-243) months. TNF antagonists were discontinued in 890 (42.8%) cycles. The reasons for discontinuation were inefficacy in 350 (39.3%), adverse events in 274 (30.8%), lack of drug provision by medical insurance in 173 (19.4%), lost to follow-up in 57 (6.4%), pregnancy in 15 (1.7%), unknown reasons in 13 (1.59%) and disease remission in 8 (0.9%) patients. ETA was discontinued in 502/1155 (45.4%), mostly 117 (23%) due to lack of insurance payment ((p=0.001), INF was discontinued in 54 (51.9%) due to persistently active disease (p=0.005). Survival of the first TNF antagonist after one year of treatment was slightly higher for certolizumab (0.85 (95% CI 0.77-0.91) and ETA (0.82, 95%CI 0.80-0.84)) compared to golimumab (95%CI 0.80, 0.65-0.89), ADA (0.79, 95%CI 0.76- 0.82) and INF (0.77, 95% CI 0.69-0.84). Among patients with concomitant use of MTX, 65.7% (585) were discontinued vs not in 830 (69.8%) (p=0.045); corticosteroids were discontinued in 50.8% vs not in 34.9% (p ≤ 0.00001). In a logistic regression model, predictors of discontinuation were: female (OR 1.59, 95% CI 1.26–2.00), ≥60 years old (OR 1.28, 95% CI 1.06–1.53), smoker (OR 1.51, 95% CI 1.11–2.05), use of corticosteroids (OR 1.97, 95% CI 1.62–2.38), INF (OR 8.73, 95% CI 5.17–14.7), ETA (OR 3.48, 95% CI 2.30–5.27) and ADA (OR 3.38, 95% CI 2.20–5.19). Concomitant use of MTX had a protective effect (OR 0.67, 95% CI 0.55–0.82).

Conclusion: We found higher rates of discontinuation of TNF antagonists in patients who used INF and ETA, including a higher frequency of discontinuation due to inefficacy in INF and lack of coverage by insurance in ETA. Specific analysis of failure predictors identified being a female, ≥60 years old, a smoker, and use of corticosteroids, INF, ETA and ADA as the main failure predictors of discontinuation of TNF antagonists in patients with chronic arthritis. On the other hand, the concomitant use of MTX had a protective effect.

Disclosure: M. J. Haye Salinas, None; S. Retamozo, None; A. Alvarellos, None; F. Caeiro, None; J. P. Pirola, None; D. Baenas, None; M. C. de La Vega, None; G. Casado, None; G. Gomez, None; J. Roberti, None; O. L. Cerda, None; I. J. Gandino, None; A. Quinteros, None; I. Exeni, None; J. M. Bande, None; J. C. Barreira, None; C. Gobbi, None; A. Alvarez, None; A. Granel, None; A. Peluzzon, None; A. Capuccio, None; R. Nieto, None; R. Quintana, None; E. Mussano, None; S. Scarafia, None; C. Costi, None; M. De La Sota, None; M. P. Diaz, None; E. J. Velozo, None; S. Aguero, None; C. Battagliotti, None; S. Soares de Souza, None; E. Cavillon, None; A. Bohr, None; A. Smichowski, None; D. Vidal, None; D. Pereira, None; L. Martinez, None; L. Somma, None; M. Zalazar, None; P. Finucci Curi, None; L. Carlevaris, None; G. Berbotto, None; V. Saurit, None.

To cite this abstract in AMA style:

Haye Salinas MJ, Retamozo S, Alvarellos A, Caeiro F, Pirola JP, Baenas D, de La Vega MC, Casado G, Gomez G, Roberti J, Cerda OL, Gandino IJ, Quinteros A, Exeni I, Bande JM, Barreira JC, Gobbi C, Alvarez A, Granel A, Peluzzon A, Capuccio A, Nieto R, Quintana R, Mussano E, Scarafia S, Costi C, De La Sota M, Diaz MP, Velozo EJ, Aguero S, Battagliotti C, Soares de Souza S, Cavillon E, Bohr A, Smichowski A, Vidal D, Pereira D, Martinez L, Somma L, Zalazar M, Finucci Curi P, Carlevaris L, Berbotto G, Saurit V. Failure Predictors to Anti-Tumor Necrosis Antagonists in Patients with Chronic Arthritis: Results of a National Registry Biobadasar [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/failure-predictors-to-anti-tumor-necrosis-antagonists-in-patients-with-chronic-arthritis-results-of-a-national-registry-biobadasar/. Accessed .

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