FRI0152 METHOTREXATE TREATMENT PATTERNS IN ADVANCED THERAPY–NAïVE PATIENTS WITH RHEUMATOID ARTHRITIS: CLINICAL CHARACTERISTICS AND OUTCOMES OF PATIENTS IN THE CORRONA REGISTRY
Authors: Leslie Harrold, Heather J. Litman, Jacqueline O’brien, Hua Feng, Casey Schlacher, Namita Tundia
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Methotrexate (MTX) is one of the most commonly used drugs in the treatment of rheumatoid arthritis (RA). Some patients may discontinue MTX therapy due to lack of efficacy or intolerance and may or may not restart MTX. There is a need to better understand the patterns of MTX use, the characteristics of these patients, and how the patterns of use are related to outcomes. <h3>Objectives</h3> To assess patterns of MTX use in a clinical practice setting, describe baseline demographic and clinical characteristics for groups defined by patterns of MTX use, and assess the association of patterns of MTX use with clinical outcomes and side effects during the 2 years after MTX initiation. <h3>Methods</h3> This observational study included patients from the US Corrona RA registry who initiated MTX from 01 October 2001 to 31 October 2018, were biologic/targeted synthetic disease-modifying antirheumatic drug (bDMARD/tsDMARD)–naïve and did not start bDMARD/tsDMARD through 2 years of follow-up. Patients were divided into 3 cohorts: those who discontinued and restarted MTX, those who discontinued without restarting MTX and those who persisted on MTX. Descriptive statistics were used to evaluate patient demographics and disease activity at MTX initiation and side effects during follow-up. Changes in clinical outcomes from baseline to 2 years were calculated for all groups. Differences in outcomes were assessed using Kruskal-Wallis one-way analysis of variance for continuous or ordinal-dependent variables and chi-square test for categorical variables. <h3>Results</h3> Among 785 MTX initiators, 34 (4.3%) discontinued/restarted MTX, 174 (22.2%) discontinued MTX, and 577 (73.5%) persisted on MTX within the 2-year follow-up period. Overall, mean age was 59.7 years; 72.7% were female; mean duration of RA was 4.8 years; and 52.9% were conventional synthetic DMARD–naïve. Generally, in patients who discontinued/restarted, discontinued, or persisted on MTX, those who discontinued/restarted therapy had more comorbidities at MTX initiation: hypertension (35.3%, 32.8%, or 29.3%, respectively), malignancy (14.7%, 9.2%, or 8.7%, respectively), chronic obstructive pulmonary disease (10.0%, 3.9%, 1.9%, respectively), or asthma (5.0%, 4.7%, or 2.9%, respectively). At end of follow-up, mean Clinical Disease Activity Index (CDAI) was 15.6, 10.1, and 8.8 for those who discontinued/restarted, discontinued, and persisted, respectively. Disease activity according to CDAI improved during the 2-year follow-up for all 3 groups, but less improvement was observed in those who discontinued/restarted MTX (<b>Table</b>). Overall, the most common side effects while on MTX therapy were elevated liver enzymes (65.4%) and fatigue (43.1%). Patients who discontinued/restarted MTX vs those who persisted had higher rates of hair loss (35.3% vs 18.9%), loss of appetite (32.4% vs 17.3%) stomach pain (26.5% vs 14.6%), mouth sores (20.6% vs 16.3%), diarrhœa (11.8% vs 9.5%), and myelosuppression (8.8% vs 2.1%). <h3>Conclusion</h3> More than 26% of patients who initiated MTX therapy either discontinued and did not restart or discontinued and restarted therapy during 2 years of follow-up. Patients who discontinued/restarted MTX therapy had less improvement in disease activity, experienced more side effects, and tended to have more comorbidities at MTX initiation than those who persisted on therapy. <h3>Acknowledgement</h3> This study was sponsored by Corrona, LLC. Corrona is supported through contracted subscriptions with multiple pharmaceutical companies. The abstract was a collaborative effort between Corrona and AbbVie with financial support provided by AbbVie. <h3>Disclosure of Interests</h3> Leslie Harrold Shareholder of: Corrona, Grant/research support from: Pfizer, Consultant for: AbbVie, BMS, and Genentech, Employee of: Corrona, Heather J. Litman: None declared, Jacqueline O'Brien Employee of: Corrona, Hua Feng Employee of: Corrona, Casey Schlacher Shareholder of: AbbVie, Employee of: AbbVie, Namita Tundia Shareholder of: AbbVie, Employee of: AbbVie