Discontinuation Causes of Biological Therapies: Over a Five-Year Period. Biobadasar

Diego Baenas¹, Soledad Retamozo², Alejandro Alvarellos², Francisco Caeiro³, Maria Jezabel Haye Salinas¹, Juan Pablo Pirola³, María Celina de La Vega⁴, Gustavo Casado⁵, Gimena Gomez⁶, Javier Roberti⁷, Osvaldo Luis Cerda⁸, Ignacio Javier Gandino⁹, Ana Quinteros¹⁰, Ida Exeni^5,11, Belen Barrios¹², Carla Gobbi¹³, Analia Alvarez¹⁴, Amelia Granel¹⁵, Alejandra Peluzzon¹⁶, Ana Capuccio¹⁷, Romina Nieto¹⁸, Rossana Quintana^19,20, Eduardo Mussano^21,22, Santiago Scarafia²³, Mercedes Argentina García²⁴, Mercedes De La Sota²⁵, Karin Kirmayr²⁶, Edson Javier Velozo²⁷, Santiago Aguero²⁸, Cristina Battagliotti²⁹, Sidney Soares de Souza³⁰, Emilia Cavillon³¹, Analia Bohr³², Andrea Smichowski³³, Alejandro Benitez³⁴, Daniela Vidal³⁵, Dora Pereira³⁶, Liliana Martinez³⁷, Luis Somma³⁸, Marta Zalazar³⁹, Pablo Finucci Curi⁴⁰, Leandro Carlevaris⁴¹, Guillermo Berbotto⁴² and Veronica Saurit⁴³, ¹Hospital Privado Centro Médico de Córdoba, Córdoba, Argentina, ²Rheumatology Unit, Hospital Privado Centro Médico de Córdoba, Postgraduate Career of Rheumatology Catholic University of Córdoba, Fundación para las Ciencias Biomédicas de Córdoba (FUCIBICO), Cordoba, Argentina, ³Rheumatology, Hospital Privado Centro Médico de Córdoba, Córdoba, Argentina, ⁴Sociedad Argentina de Reumatología, CABA, Argentina, ⁵Sociedad Argentina de Reumatologia, CABA, Argentina, ⁶Sociedad Argentina de Reumatología, Buenos Aires, Argentina, ⁷SAR, CABA, Argentina, ⁸Rheumatology Section, Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, ⁹Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ¹⁰Centro Integral Reumatológico, Tucuman, Argentina, ¹¹Sanatorio Parque, Cordoba, Argentina, ¹²Hospital Tornu, CABA, Argentina, ¹³Rheumatology, Sanatorio Allende de Córdoba, Cordoba, Argentina, ¹⁴Hospital Penna, Bahía Blanca, Argentina, ¹⁵Centro Platense de Reumatología, La Plata, Argentina, ¹⁶Hospital Clínica José de San Martín, CABA, Argentina, ¹⁷Hospital Cesar Milstein, CABA, Argentina, ¹⁸Hospital Provincial, Rosario, Argentina, ¹⁹Sanatorio Parque, Rosario, Argentina, ²⁰SAR, Rosario, Argentina, ²¹Córdoba, Hospital Nacional de Clínicas, Córdoba, Argentina, ²²SAR, Cordoba, Argentina, ²³Hospital Bernardino Rivadavia, CABA, Argentina, ²⁴Rheumatology Unit, HIGA San Martín La Plata, La Plata, Argentina, ²⁵Consultorios, Bahia Blanca, Argentina, ²⁶Sociedad Argentina de Reumatologia. Argentina, CABA, 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, ³⁴CEIM, CABA, Argentina, ³⁵Hospital de Niños de Córdoba, Córdoba, Argentina, ³⁶Centro Raquis, Buenos Aires, Argentina, ³⁷Hospital Fernandez, CABA, Argentina, ³⁸SOMMA, Buenos Aires, Argentina, ³⁹Hospital Pirovano, CABA, Argentina, ⁴⁰Centro Médico Mitre, Entre Rios, Argentina, ⁴¹IARI, CABA, Argentina, ⁴²Sanatorio Británico, Rosario, Argentina, ⁴³Hospital Privado Centro Médico de Córdoba, Cordoba, Argentina

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: adverse events and data analysis, Biologic agents

Session Information

Date: Monday, November 14, 2016

Title: Miscellaneous Rheumatic and Inflammatory Diseases - Poster II

Session Type: ACR Poster Session B

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

Background/Purpose: To analyze discontinuation causes of biologics therapies (bDMARDs) in patients who are registered in the database BIOBADASAR.

Methods: Database included demographics of patients, type and duration of treatments and clinical information of adverse events. A control group was included for comparison consisting of patients not treated with bDMARDs but similar demographics. Values are expressed as mean±standard deviation, median (ranges), and frequencies (percentages), as appropriate. Student’s t-test and the chi-squared test were applied and Fisher’s exact test was used where necessary. Multivariate cause-specific regression models were used to measure the association with discontinuation. Values of p < 0.05 were considered to be statistically significant.

Results: From August 2010 to January 2016, 3483 patients were registered in BIOBADASAR; mean age:56.115.7 yrs; 78.9% females; 2745 (78.6%) had RA, 395 (11.3%) PsA, 150 (4.3%) JIA, 144 (4.1%) SLE, 107 (3.07%) AS. Therapy with non-bDMARDS included 2011(57.7%) patients. Different bDMARDs were used in 1472 (42.3%) patients for a total of 2736 (1.85/patients) treatments cycles. Of these, 1184 (45.8%) were discontinued; etanercept 43.6% (521/1193), infliximab 64.1% (109/156), abatacept 43.5% (123/283), adalimumab 41.2% (262/626), rituximab 34.5% (78/226), belumimab 29.2% (7/24), golimumab 21.6% (11/51), certolizumab 16.6% (20/120) and tofacitinib 8.8% (5/57). The main reasons for bDMARD discontinuation were: Inefficacy: 450 (38%); adverse events 368 (31.1%); lack of insurance: 239 (20.2%) Discontinuation due to inefficacy was significantly higher in patients who were treated with infliximab; and tofacinitib showed a higher frequency of switching due to adverse events in comparison with the rest of biological agents (Table 1). In a logistic regression model, predictors associated with discontinuation of bDMARD treatment were: older age (OR 1.01 95% CI 1.01-1.02), concomitant use of corticoids (OR 1.72, 95% CI 1.44-2.04) and use of infliximab (OR 2.17, 95%CI 1.53-3.08). However, use of tofacitinib (OR 0.14, 95%CI 0.04-0.48, p=0.002), certolizumab (OR 0.21, 95%CI 0.11-0.39, p ≤ 0.00001), golimumab (OR 0.34, 95%CI 0.15-0.80, p=0.014) and rituximab (OR 0.68, 95%CI 0.49-0.95, p=0.026) showed less discontinuation rate. Table 1. Discontinuation causes of biologics therapies in BIOBADASAR

Reason for discontinuation	Abatacept n (%)	Adalimumab n (%)	Belimumab n (%)	Certolizumab n (%)	Etanercept n (%)	Golimumab n (%)	Infliiximab n (%)	Rituximab n (%)	Tocilizumab n (%)	Tofacitinib n (%)
Adverse event	32(26)	86(32.8)	1(14.3)	8 (40)	152(29.2)	5(45.5)	34(31.2)	28(35.9)	18(37.5)	4 (80) a
Unknown	1(0.8)	3(1.2)	0(0)	0(0)	8(1.5)	1(9.1)	1(0.9)	3(3.9)	1(2.1)	0(0)
Pregnancy	0(0)	3(1.2)	1(14.3)	2(10)	10(1.9)	0(0)	0(0)	1(1.3)	0(0)	1 (20)
Inefficacy	53(43.1)	106(40.5)	3(42.9)	8 (40)	192(36.9)	4(36.4)	55(50.5) b	16(20.5) c	13(27.1)	0(0)
Lack of cover	29(23.6)	44(16.8)	0(0)	2(10)	121(23.2)	1(9.1)	9(8.3) d	19(24.4)	14(29.2)	0(0)
Lost of follow up	7(5.7)	18(6.9)	0(0)	0(0)	33(6.3)	0(0)	7(6.4)	6(7.7)	0(0)	0(0)
Remission	1(0.8)	2(0.8)	2(28.6) e	0(0)	5(1)	0(0)	3(2.8)	5(6.4) f	2(4.2)	0(0)
total	123(100)	262(100)	7 (100)	20 (100)	521(100)	11(100)	109(100)	78(100)	48(100)	5 (100)

P values: a. 0.035; b. 0.005; c. 0.001; d. 0.001; e. 0.005; f. 0.008. Chi2 test or Fisher’s exact test as appropriate

Conclusion: Discontinuation was significantly associated with older age, corticosteroid use and infliximab therapy. Certolizumab, Golimumab and Rituximab had protective effect against discontinuation.

Disclosure: D. Baenas, None; S. Retamozo, None; A. Alvarellos, None; F. Caeiro, None; M. J. Haye Salinas, None; J. P. Pirola, 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; B. Barrios, 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; M. A. García, None; M. De La Sota, None; K. Kirmayr, 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; A. Benitez, 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:

Baenas D, Retamozo S, Alvarellos A, Caeiro F, Haye Salinas MJ, Pirola JP, de La Vega MC, Casado G, Gomez G, Roberti J, Cerda OL, Gandino IJ, Quinteros A, Exeni I, Barrios B, Gobbi C, Alvarez A, Granel A, Peluzzon A, Capuccio A, Nieto R, Quintana R, Mussano E, Scarafia S, García MA, De La Sota M, Kirmayr K, Velozo EJ, Aguero S, Battagliotti C, Soares de Souza S, Cavillon E, Bohr A, Smichowski A, Benitez A, Vidal D, Pereira D, Martinez L, Somma L, Zalazar M, Finucci Curi P, Carlevaris L, Berbotto G, Saurit V. Discontinuation Causes of Biological Therapies: Over a Five-Year Period. Biobadasar [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/discontinuation-causes-of-biological-therapies-over-a-five-year-period-biobadasar/. Accessed .

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