Prospective, Intervention, Multicenter Study of Utility of Biologic Drug Monitoring with Respect to the Efficacy and Cost of Adalimumab Tapering in Patients with Rheumatic Diseases (34-week descriptive data)

Iñigo Gorostiza¹, Eduardo Úcar Angulo², Catalina Gómez Arango², Clara Eugenia Perez³, Juan Ramon De Dios⁴, Belen Alvarez⁴, Ana Ruibal Escribano^4,5, Claudia Stoye⁴, Margarida Vasques⁴, Joaquin Belzunegui Otano⁶, Antonio Escobar⁷, Ziortza Trancho⁸, Ainhoa Ruiz del Agua⁹, Lorena Del Rio⁹, Antonio Martínez⁹ and Daniel Nagore⁹, ¹Research Department, Hospital Universitario de Basurto, Bilbao, Spain, ²Rheumatology, Rheumatology Department, Basurto University Hospital, Bilbao, Spain, ³Rheumatology, Hospital Universitario de Basurto, Bilbao, Spain, ⁴Rheumatology, Hospital Universitario de Araba, Vitoria, Spain, ⁵Rheumatology, Hospital Universitario de Araba, Vittoria, Spain, ⁶Donostia University Hospital, San Sebastian, Spain, ⁷Unidad de Investigación, Red de Investigación en Servicios de Salud en enfermedades crónicas (REDISSEC), Hospital Universitario de Basurto, Bilbao, Spain, ⁸Unidad de Investigación, Hospital Universitario de Basurto, Bilbao, Spain, ⁹R&D, Progenika-Grifols, Derio, Spain

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Adalimumab, Biologic drugs, health care cost and rheumatic disease

Session Information

Date: Sunday, November 13, 2016

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster I

Session Type: ACR Poster Session A

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

Background/Purpose: Adalimumab (ADL) dose tapering based on clinical assessment is a usual practice especially in patients who have achieved clinical remission. The primary aim of this study is to analyze how personalized management guided by biological drug monitoring (BDM) in moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients impacts the annual direct costs of these patients to the Health System and the quality-adjusted life year with respect to conventional practice in Spain. Secondly, to evaluate the effectiveness of BDM in the reduction of the number of days with high disease activity compared with conventional practice. Follow up will be completed in December 2016; here we present partial descriptive data at 34 weeks.

Methods: Adult patients with RA, PsA or AS treated with ADL who have remained clinically stable for at least 6 months were recruited in three sites. Patients were grouped in Control and Intervention groups according to the recruiting site. All patients were treated with 40 mg of subcutaneous ADL and treatment frequency was adjusted based on physician criteria. All patients are assessed at 8 timepoints (8 visits) for up to 18 months. Trough ADL and anti-drug antibodies levels are measured with Promonitor-ADL and Promonitor-ANTI-ADL (Progenika, Spain). BDM data are released only to the Intervention group, and blinded to the Control group (managed according to clinical assessment only). Physicians in the Intervention group are not obliged to follow any therapeutic algorithm based on BDM results but can use tests to alter doses based on their judgement. Endpoints include DAS28, BASDAI, BASFI and HAQ-DI scores at every timepoint. Criteria for assessing disease scores are identical in the three sites. Cost-effectiveness will be evaluated according to associated costs and QALY.

Results: A total of 169 patients have been recruited (Disease, N Intervention, N Control groups, %) (RA, 30, 33, 37.3%; PsA, 33, 21, 32%; and AS, 46, 6, 30.8%). Median disease duration was 117, 98.5 and 101.5 months for RA, PsA and AS, respectively. At baseline, 10 (16.7%) and 29 (26.6%) patients had low disease activity and 50 (83.3%) and 80 (73.4%) patients were in remission in the Control and Intervention groups respectively, with median trough ADL levels 5.5 and 5.3 mg/L in the Control and Intervention groups respectively. At week 34 median trough ADL levels were 5.2 and 5.5 mg/L in the Control and Intervention groups respectively. Out of the total number of patients who were in remission at baseline (n=117), 69.6% (32/46) and 76.1% (54/71) remained in remission at week 34 in the Control and Intervention groups, respectively. Out of the patients who had low disease activity at baseline (n=35), 28.6% (2/7) and 35.7% (10/28) were in remission at week 34 in the Control and Intervention groups, respectively.

Conclusion: Partial descriptive data point towards a positive effect of BDM-complemented management compared to conventional practice only. This study will provide evidence on the clinical utility of personalized management of patients based on clinical assessment and biological drug monitoring (drug and anti-drug antibody levels) for adalimumab in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis compared to management based on clinical assessments alone.

Disclosure: I. Gorostiza, None; E. Úcar Angulo, None; C. Gómez Arango, None; C. E. Perez, None; J. R. De Dios, None; B. Alvarez, None; A. Ruibal Escribano, None; C. Stoye, None; M. Vasques, None; J. Belzunegui Otano, None; A. Escobar, None; Z. Trancho, None; A. Ruiz del Agua, Progenika, 3; L. Del Rio, Progenika, 3; A. Martínez, Progenika, 3; D. Nagore, Progenika, 3.

To cite this abstract in AMA style:

Gorostiza I, Úcar Angulo E, Gómez Arango C, Perez CE, De Dios JR, Alvarez B, Ruibal Escribano A, Stoye C, Vasques M, Belzunegui Otano J, Escobar A, Trancho Z, Ruiz del Agua A, Del Rio L, Martínez A, Nagore D. Prospective, Intervention, Multicenter Study of Utility of Biologic Drug Monitoring with Respect to the Efficacy and Cost of Adalimumab Tapering in Patients with Rheumatic Diseases (34-week descriptive data) [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/prospective-intervention-multicenter-study-of-utility-of-biologic-drug-monitoring-with-respect-to-the-efficacy-and-cost-of-adalimumab-tapering-in-patients-with-rheumatic-diseases-34-week-descriptiv/. Accessed .

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