Use of Biologic Drugs and Adverse Events in Patients with Rheumatic Disease: DATA from the Mexican Biologics Registry

Daniel Xibille-Friedmann¹, Sandra Miriam Carrillo -Vazquez², Sandra Sicsik Ayala³, Fedra Irazoque-Palazuelos⁴, Azucena Ramos-Sanchez⁵, Sergio Duran-Barragan⁶, Miguel A Saavedra⁷, Leonor Barile⁸ and Guadalupe Olvera⁹, ¹Research and Training Department, Servicios de Salud de Morelos, Cuernavaca, Mexico, ²Rheumatology, Hospital 1 de Octubre ISSSTE, Mexico City, Mexico, ³Rheumatology, UMAE 71 IMSS, Torreon, Mexico, Torreon, Mexico, ⁴Rheumatology Department, CMN 20 de Noviembre ISSSTE,, CDMX, Mexico, ⁵Rheumatology, CMN NE 25 IMSS, Monterrey, Mexico, ⁶Centro Universitario de Ciencias de la Salud, Instituto de Investigación en Reumatología y del Sistema Músculo Esquelético, Universidad de Guadalajara, Guadalajara, Mexico, ⁷Novartis Farmaceutica, Calz de Tlaplan 1779, Mexico, Mexico, ⁸Hospital Ángeles del Pedregal, Mexico, Mexico, ⁹Research Department, Colegio Mexicano de Reumatologia, Mexico City, Mexico

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Adverse events, biologic drugs and registries

Session Information

Date: Monday, October 22, 2018

Title: Health Services Research Poster II – ACR/ARHP

Session Type: ACR/ARHP Combined Abstract Session

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

Background/Purpose: National registries of biologic drugs have proven to be valuable tools in following patients with rheumatic disease and some outcomes in real-life situations. The objective of this study was to describe Mexican Rheumatologists’ preferences when treating patients with biologic drugs and to analyze factors associated to the use of this therapy.

Methods: Data from patients undergoing biologic treatment in Mexico is gathered into the BIOBADAMEX online database, which is part of the BIOBADAMERICA initiative and based on the BIOBADASER Phase 3 platform. Phase 3 in Mexico started gathering patient data in April 2016 and to date has information on 283 patients. The database collects information such as gender, age, diagnosis, disease duration, biologic treatment, DMARD treatment, concomitant therapy, motives for discontinuation of biologics, comorbidities, adverse event (AE) severity, infection site and germ involved. Descriptive statistics were applied on the data collected from April 2016 to April 2018.

Results: We analyzed data on the use of 267 biologic treatments in 289 patients. Most of them receive biologic therapy through socialized medical insurance programs which may have led to bias. 82% of patients were female, mean age 49±15.2 (4-85) years, 42.5% belonging to the <50 group. 70.9% of patients in the registry have RA, 15.9% AS and 5.1% PsA. Mean disease duration is 11±8.9 (0-58) years. The most commonly used biologic overall is Abatacept (15.3%), followed by Adalimumab (13.8%), Tocilizumab (11.2%), Certolizumab (10.1%), Golimumab (8.6%), Rituximab (8.2%), Etanercept biosimilar (7.4%), Etanercept (6.3%), Infliximab (4.1%) and Benlystia (1.1%). All others, including JAK inhibitors, are used in <1% of patients. The preference for first biologic drug was Etanercept (32.4%), followed by Adalimumab (12%), Infliximab (8.3%), Rituximab and Tocilizumab (5.5% each) and Abatacept (2.7%). The most commonly used second-line biologics were golimumab, the etanercept biosimilar and abatacept. Most treatments were stopped due to lack of efficacy (60.4%), disease remission (7.4%), other causes (20.1%), AE (4.4%), with the rest of the causes each affecting <5% of patients. 18.5% of AE were considered severe. Comorbidities were present in 87 patients (40%), the most common being Hypertension (13.4%), Diabetes (7.8%) and Dyslipidemia (6.9%). Non-lymphoma neoplasms were reported in 1.3%. 25% of AE were considered serious but most (70%) were mild. Only 6 patients reported infections with the most common sites being the skin (33.3%), urinary tract (16.6%) and middle-ear (16.6%). The causal germ was undetermined in half of the cases of infection.

Conclusion:

When using biologic drugs, TNF inhibitors are the most commonly used initial mechanism of action for the treatment of rheumatic diseases in the BIOBADAMEX registry. Upon treatment failure, patients often undergo a switch to another mechanism of action, mainly using Abatacept. Adverse events and infections related to the use of biologics are infrequent, but 40% of patients present chronic comorbidities.

Disclosure: D. Xibille-Friedmann, None; S. M. Carrillo -Vazquez, None; S. Sicsik Ayala, None; F. Irazoque-Palazuelos, None; A. Ramos-Sanchez, None; S. Duran-Barragan, None; M. A. Saavedra, None; L. Barile, None; G. Olvera, None.

To cite this abstract in AMA style:

Xibille-Friedmann D, Carrillo -Vazquez SM, Sicsik Ayala S, Irazoque-Palazuelos F, Ramos-Sanchez A, Duran-Barragan S, Saavedra MA, Barile L, Olvera G. Use of Biologic Drugs and Adverse Events in Patients with Rheumatic Disease: DATA from the Mexican Biologics Registry [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/use-of-biologic-drugs-and-adverse-events-in-patients-with-rheumatic-disease-data-from-the-mexican-biologics-registry/. Accessed .

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