Does Tofacitinib Improve Comorbid Depressive and/or Anxiety Symptoms in Patients with Rheumatoid Arthritis?
Depression and anxiety disorders are commonly observed in patients with rheumatoid arthritis and can lead to a reduction in quality of life, functional capacity, and, last but not least, to a lower therapeutic response. Therefore, the study presented below examined the prevalence of depressive and generalized anxiety disorders in clinical trials using tofacitinib and the effectiveness of tofacitinib according to baseline values of depression and anxiety.
Tofacitinib is an orally administered Janus kinase (JAK) inhibitor, which belongs to the group of disease-modifying anti-rheumatic drugs (DMARDs) and can be used as monotherapy. It is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA).
Methodology of Analysis
This was a post-hoc analysis of data from phase III and IV studies. Included were patients with RA receiving tofacitinib at a dose of 5 (n = 1847) or 10 mg twice daily (n = 1122) or adalimumab 40 mg once every 2 weeks (n = 557) or placebo (n = 611). The 36-Item Short Form Health Survey (SF-36) was used to recognize probable depressive and generalized anxiety disorders, specifically evaluating the mental health component summary score (MCS) of the questionnaire.
Baseline disease characteristics were assessed according to the SF-36 MCS score (SF-36 MCS ≤ 38 = depression or anxiety present, MCS > 38 = absent). Changes in SF-36 MCS were reported every 3 months. At the 3rd, 6th, and 12th month of the study, the efficacy targets were estimated by comparing the initial values of depressive or anxiety disorders in patients treated with tofacitinib.
Results
At study entry, 44.5% of patients treated with 5 mg tofacitinib, 39.8% of patients treated with 10 mg tofacitinib, 45.4% of patients with adalimumab, and 39.1% of patients in the placebo group had depressive or generalized anxiety disorders. Patients with psychological comorbidity had higher CRP levels, greater disability, fatigue, pain, and sleep problems than others. Compared to adalimumab or placebo, patients treated with tofacitinib showed a higher increase in SF-36 MCS score. After 12 months, the number of patients treated with tofacitinib who had SF-36 MCS scores ≤ 38 decreased by approximately 60%. The effect of tofacitinib on the treatment of RA was similar regardless of the presence of depression or anxiety.
Conclusion and Discussion
Nearly 40% of the observed patients with RA were identified with concurrent depressive and/or generalized anxiety disorder, which improved more in patients treated with tofacitinib during the study than in other arms. A limiting factor of the study was determining the probable occurrence of depressive or generalized anxiety disorder based solely on questionnaire surveys, without clinical confirmation of the diagnosis. Therefore, future studies will need to validate the SF-36 MCS score using the gold standard of psychiatric examination.
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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 n. 1444.
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