Clinical Evaluation Usefulness of Standardized Protocol Strategies of Dose Reduction in Patients with Rheumatoid Arthritis in Clinical Remission Treated with Biologic Therapies. the Optibio Study

Carmen Bejerano¹, Natividad Oreiro¹, Carlos Fernandez-Lopez², Jose A Pinto-Tasende¹, Antonio Atanes¹, Bruno De Aspe¹, Genaro Graña Gil¹, Mercedes Freire¹, Manuel Acasuso³, Sonia Pertega⁴, Francisco J. de Toro¹ and Francisco J Blanco¹, ¹Rheumatology Division, INIBIC-Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruna, Spain, ²Rheumatology Division, INIBIC-Complejo Hospitalario Universitario A Coruña (CHUAC), La Coruña, Spain, ³Centro de Salud San Jose, XAP Coruna, A Coruna, Spain, ⁴Epidemiology Unit, INIBIC - Complejo Hospitalario Universitario A Coruña, A Coruña, Spain

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: biologic response modifiers, clinical trials, remission and rheumatoid arthritis, treatment

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:

The OPTIBIO study is a clinical trial whose primary endpoint is to evaluate the proportion of patients that after one year are maintained in clinical remission with a dose reduction treatment regimen of biological therapy in patients with Rheumatoid Arthritis (RA), and to evaluate if the proportion of patients in remission with new regimen dose of treatment is not inferior to patients in remission with standard dose regimen. In our present work, we describe the preliminary results obtained so far.

Methods:

Open, randomized and controlled study of patients in clinical remission (DAS 28 <2.6 or SDAI <5 or ACR/EULAR 2011 criteria) at least 6 months followed in Third level Hospital Rheumatology Department. Patients treated with TNF inhibitors therapies (Etanercept, Infliximab, Adalimumab, Certolizumab, Golimumab), Tocilizumab and Abatacept. Patients are assigned to two groups randomly. Intervention group: according to a standardized protocol of dose reduction of biological therapies, Control group: according to standard dose regimen. Flare is considered when DAS28>2.6 or SDAI>5 or ACR/EULAR criteria are not fulfilled. Patients are following during after a minimum period of one year and maximum period of 3 years. The frequency of visits is every 12 weeks.

Results:

66 patients have been included from 14 April 2014 to 28 April 2016. Fifty-five women (83.33%) and 11 men (16.66%) with a mean age of 59.68 ± 11.72 years. Thirty-four patients in standard regimen dose and 32 patients in dose reduction regimen with comparable baseline characteristics for both groups. Positive Rheumatoid Factor (RF) in 80.30%. Forty-seven patients have erosive disease. None of the patients had tender or swollen joints at the beginning. At baseline, ESR and CRP values were 16.65 ±10.48 mm/1hour y 0.22 ± 0.23 mg/dl respectively, DAS 28-ESR value was 1.83 ±0.72 and DAS28-CRP was 1.35 ± 0.26. SDAI baseline value was 1.36 ± 1.00. Eighteen patients have presented a flare: 20.58 % in control group and 34.37 % in intervention group without statistical signification (p=0.209) with a Relative Risk (RR) 1.66 [0.73 – 3.77]. Baseline characteristics of the patients are described in tables 1 and 2

Conclusion: Preliminary results show that dose reduction of biological therapies with a standardized protocol it does not seem to increase reactivation risk of disease activity,

Disclosure: C. Bejerano, None; N. Oreiro, None; C. Fernandez-Lopez, None; J. A. Pinto-Tasende, None; A. Atanes, None; B. De Aspe, None; G. Graña Gil, None; M. Freire, None; M. Acasuso, None; S. Pertega, None; F. J. de Toro, None; F. J. Blanco, Bioibérica, Gebro Pharma, Pfizer, 5.

To cite this abstract in AMA style:

Bejerano C, Oreiro N, Fernandez-Lopez C, Pinto-Tasende JA, Atanes A, De Aspe B, Graña Gil G, Freire M, Acasuso M, Pertega S, de Toro FJ, Blanco FJ. Clinical Evaluation Usefulness of Standardized Protocol Strategies of Dose Reduction in Patients with Rheumatoid Arthritis in Clinical Remission Treated with Biologic Therapies. the Optibio Study [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/clinical-evaluation-usefulness-of-standardized-protocol-strategies-of-dose-reduction-in-patients-with-rheumatoid-arthritis-in-clinical-remission-treated-with-biologic-therapies-the-optibio-study/. Accessed .

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