Background/Purpose: The recent publication of the concerto trial comparing the use of adalimumab in monotherapy versus in association with methotrexate (MTX) at dose varying from 2.5 to 20 mg weekly increased the awareness of the importance of anti-drug antibody in lowering the efficacy of adalimumab in patients with RA. Rhumadata®, a real life clinical database and registry, gives a unique opportunity to compare the two strategies over the very long term. Our objective is to evaluate the impact the combination of MTX over monotherapy on long term retention rate of adalimumab in a population of patients with RA followed at the institut de recherche en rhumatologie de Montréal (IRRM) ant the Centre d’ostéoporose et de rhumatologie de Québec(CORQ) and entered in the RHUMADATA® Clinical database and registry.

Methods: Data of RA patients who had been prescribed adalimumab (ADA) in any intention on or after January 1st 2002 was extracted.  The data included age and gender, disease characteristics, clinical variables, patient and physician specific assessments, and laboratory measures. Composite assessment of disease activity including the DAS28-ESR and the simplified and clinical disease activity indices (SDAI and CDAI) were calculated using readily available formulas. All patients were followed until they discontinued their treatment or June 2, 2015, the date at which the data was extracted from Rhumadata®. Secondary diagnoses and comorbidities established at or before the administration of the biologic agents were coded using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. Infections occurring while on treatment, biologic status (ongoing or stopped) and the reasons for biologic cessation were also extracted. The 10-year drug retention rates were estimated and compared using Kaplan-Meier survival estimates. Statistical analysis was performed using SAS version 9.4. 

Results: The data from 290 patients prescribed ADA (219 in combination therapy and 71 in mono therapy) in any intention were extracted from the RHUMADATA® clinical registry and database. The patients were mostly women (73.1%) and had an average age of 52.6(SD=12.8).  The patients had an average disease duration of 7.4 years (SD=7.6) and were exposed to ADA for an average of 3.0 years (SD=3.1) providing 883.3 person-years of treatment. Patients prescribed MTX received an average daily dose of 15.4 mg (SD=6.1). The 10-year retention rates of ADA used in MONO and COMBO therapy were estimated at 13.6% (SD=5.4%) and 22.4% (SD=3.4%) respectively and an overall significant difference in retention rate was observed (log-rank p -value = 0.0107). 

 Conclusion: Using adalimumab in combination with methotrexate improve significantly the retention rate in patients suffering of RA

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/comparative-10-year-retention-rates-of-adalimumab-used-in-mono-and-combination-therapy-in-rheumatoid-arthritis-ra-patients-from-the-rhumadata-clinical-database-and-registry/