Can tofacitinib have a positive impact on the mental stress of patients with rheumatoid arthritis?
In the population of patients with rheumatoid arthritis (RA), there is a higher incidence of depression and anxiety compared to the healthy population. These psychiatric comorbidities can lead to a reduced quality of life and a poorer response to treatment. The aim of the post-hoc analysis presented below was to monitor the effect of tofacitinib on improving anxiety and depression in patients with RA.
Mental health and its assessment in patients with RA
Rheumatoid arthritis is a chronic systemic disease that, in addition to joint involvement, can also variously manifest in organ damage and disruption of mental health. One possible causal link between depression or anxiety and RA is elevated levels of interleukin 6 (IL-6), which have been found in patients with concurrent RA and depression.
An important indicator of the severity of the disease in rheumatologic patients is health-related quality of life (HRQoL). One possible tool for measuring HRQoL is the structured questionnaire SF-36, which uses 36 questions to evaluate 8 domains of life (from physical health and performance to mental health and psychological well-being). The result for individual domains is given on a scale of 0−100, where a higher score means better condition and higher quality of life. The score can be transformed into a single global score or into two components, assessing mental (MCS − Mental Component Summary) and physical (PCS − Physical Component Summary) functions separately. MCS ≤ 38 is an indicator of probable major depressive disorder (pMDD) or generalized anxiety disorder (GAD).
Post-hoc analysis
The analysis included data from 5 phase III clinical studies and 1 phase IIIB/IV study. Patients received tofacitinib at a dose of 5 or 10 mg twice daily, adalimumab at a dose of 40 mg every other week, or placebo. The analysis included demographic data of patients and the presence or absence of pMDD or GAD at the start of therapy (baseline MCS > 38 or ≤ 38). The change in MCS over time was evaluated at 3, 6, 9, and 12 months from the start of therapy, calculations and estimates were made using linear models.
Results
At the start of the studies, MCS ≤ 38 was reported in roughly 40% (39–45%) of patients. In this group, higher baseline values of inflammatory parameters (C-reactive protein), as well as more frequent occurrences of fatigue, pain, sleep disturbances, and overall worsened condition, were also found. After 12 months of treatment, the proportion of patients with MCS ≤ 38 in the group treated with tofacitinib decreased by 60%. The proportion of patients with persistent manifestations of pMDD or GAD decreased with the length of tofacitinib treatment and was generally lower compared to patients who received adalimumab or placebo.
Discussion and conclusion
The post-hoc analysis of data from 6 studies suggests a favorable effect of tofacitinib on the mental health of patients with RA. A limitation of this work is the assessment of mental health and its changes using the SF-36 questionnaire, and thus only the probability of the occurrence of psychiatric comorbidity, not the determination of a diagnosis based on a psychiatrist's examination. The impact of tofacitinib on the mental functions of patients with RA suggested in this analysis should therefore be verified by a study that would use a standardized psychiatric diagnostic procedure instead of the SF-36 questionnaire and its derived MCS score.
(alz)
Source: Citera G., Jain R., Irazoque F. et al. Tofacitinib in patients with rheumatoid arthritis and indicative of depression and/or anxiety: a post hoc analysis of phase 3 and phase 3b/4 clinical trials. Arthritis Rheumatol 2019; 71 (suppl. 10): abstract no. 1444.
Did you like this article? Would you like to comment on it? Write to us. We are interested in your opinion. We will not publish it, but we will gladly answer you.