Patients with refractory rheumatoid arthritis (RA) who were treated with rituximab showed improvements in health-related quality of life (HRQOL), according to a recent report from a large US registry (Harrold LR, et al. Clin Rheumatol. 2017 Jul 17. Epub ahead of print).
Leslie R. Harrold, MD, Associate Professor, Orthopedics and Physical Rehabilitation, University of Massachusetts Medical School, Worcester, and colleagues sought to determine how rituximab affects outcomes self-reported by patients by analyzing data from a cohort of 667 patients with RA who were enrolled in the US Corrona RA Registry.
“Patient-reported outcomes (PROs) include HRQOL indices, such as the ability to perform day-to-day tasks, emotional health, and the degree of pain and discomfort. PROs are increasingly being recognized as important measures in determining response to therapy in patients with RA,” Dr Harrold and colleagues said.
Patients aged ≥18 years with active RA who had previous exposure to ≥1 tumor necrosis factor inhibitors (TNFis) and had recently begun treatment with rituximab were eligible for enrollment in the study. The median age of participants was 59 years, and >75% were women. Median duration of disease was 13 years. A total of 42.6% of patients had previous exposure to 1 TNFi, whereas the remaining 57.4% had been treated with ≥2 of these drugs. Approximately half (47.5%) of the patients had also received treatment with ≥2 non-TNFi biologic drugs.
Outcomes measures included the Clinical Disease Activity Index (CDAI); modified Health Assessment Questionnaire (mHAQ) and EuroQoL EQ-5D scores; global disease activity, pain, and fatigue (based on a visual analog scale of 0-100); and morning stiffness. At baseline, >50% of patients in the study exhibited high disease activity (defined as a CDAI score >22), and the median baseline mHAQ score was 0.6. On the EuroQoL index, difficulties in walking were reported by 75.7% of patients, difficulties with usual activities by 81.1%, and difficulties related to pain and discomfort by 95.8%. Approximately 50% of patients had difficulties with self-care, and the same amount reported anxiety or depression. The median baseline scores for patient global assessment, pain, and fatigue were 40, 60, and 65, respectively, and the median duration of morning stiffness was 60 minutes.
Changes in PROs were evaluated 1 year after patients had begun treatment with rituximab. The median improvement in CDAI after 1 year was 8 points, with results being comparable among patients who had received 1 previous TNFi and those who had received ≥2 previous TNFis. However, a higher percentage of patients with exposure to only 1 TNFi achieved low disease activity or remission versus those who had been exposed to ≥2 of these drugs (37.7% vs 25.1%, respectively; P <.001).
Median improvements on the 100-point visual analog scale for patient global assessment, pain, and fatigue were reported by 49%, 47.1%, and 49.8% of patients, respectively. On the mHAQ, a clinically meaningful improvement was observed in 23.2% of patients. Furthermore, among patients who reported difficulties on the EuroQoL index, improvements at 1 year were seen in walking for 19%, in self-care for 30%, in usual activities for 24%, in pain and discomfort for 23%, and in anxiety and depression for 32%. Approximately 50% of the patients in the study experienced decreases in duration of morning stiffness, and approximately 20% had a decrease in this stiffness of >60 minutes.
“These results suggest that treatment with rituximab can improve HRQOL in addition to controlling or improving underlying disease in patients with long-standing RA previously treated with TNFis,” Dr Harrold and colleagues concluded.
They did acknowledge, however, that long-term effects of treatment with rituximab could not be assessed because the follow-up in this study was only 1 year.