Background/Purpose: We compared changes from baseline for 8 health-related quality of life (HR-QOL) outcomes over two years for patients with rheumatoid arthritis (RA) treated with TNF-α inhibitors (TNFi), non-TNFi biologics (Abatacept (ABA), Rituximab (RIT), and Tocilizumab (TOC)), and Tofacitinib (TOF).

Methods: Participants were patients with RA initiating 1st- and 2nd-line biologic treatment from 2004 to 2015 in the National Data Bank for Rheumatic Diseases, a US-wide observational study that assesses outcomes and medications semi-annually. Over a 2-year period, we evaluated changes in 8 HR-QOL measures (Global assessment [Global], Health Assessment Questionnaire-II [HAQ2], Pain VAS [Pain], Patient Activity Scale-II [PAS2], Short Form 36 Physical [PCS] and Mental [MCS] Component Summary, EuroQOL US [EuroQOL], and Fatigue VAS [Fatigue]). 1st-line therapy was defined as initiation of a TNFi for which the patient was na•ve to any biologic or TOF; 2nd-line therapy was the initiation of the next biologic or TOF after first-line therapy.  We calculated change scores for assessments completed after drug initiation by subtracting the baseline (observation before drug initiation) score. Our predictors of change in outcomes were study drug and time since drug initiation. We used mixed models to include fixed effects for drug and random effects for the intercept and slope of time for each individual. The interaction between drug and time was also included. To account for the non-randomization of drug groups, several covariables were added including:  baseline age, sex, race, marital status, body mass index (BMI), Rheumatic Disease Comorbidity Index (RDCI), RA duration, and concomitant use of methotrexate and/or prednisone.

Results: The 913 patients analyzed for 1st-line therapy were 79% female with a baseline mean±SD age of 59 ±12 years, RA duration of 16±13 years, and RDCI of 1.7±1.5. There were no statistically significant differences in HR-QOL change scores among TNFis for 1st-line therapy. The 2nd-line cohort (N=2612) was 84% female with mean±SD age and RA duration of 60±12 and 18±12 years, and RDCI of 1.9±1.6. Analyses showed statistically significant superior improvement of Pain (0 – 10) for RIT vs. TNFi (differences of 1.0 at month 1 and ending at 0.6 at month 8) and vs. TOC (differences of 1.6 at month 1 and ending at 1.2 at month 5). RIT also showed significant improvement vs. TNFi at months 1 – 7 for PAS2 (0 – 10), with differences starting at 0.6 at month 1 and ending at 0.4 at month 7 (See Figure).

Conclusion: Results suggest that for 2nd-line therapy, RIT may be superior to TNFi and TOC during the first 5 to 8 months for pain, and during the first ~7 months when compared to TNFi for improving patient activity. For both lines of treatment, most medications were associated with modest improvement for the majority of outcomes in at least part of the study period.