Background/Purpose: Fatigue in RA possibly resulting from alterations in the HPA axis like occurs with others RA symptoms as morning stiffness, and mood and sleep alterations. In addition, improvement of IL-6-induced anemia noted in RA patients appears to be associated with disease activity, even with fatigue. This, together with the effect of tocilizumab (TCZ) in reducing morning stiffness, pain and fatigue, and improving Hb levels, has led us to investigate the correlation between the change in fatigue and related factors as serum Hb levels, SJC, morning stiffness, pain, sleepiness and depression.

Methods: A prospective, observational and multicenter study in patients with moderate to severe RA, non-responders or intolerants to DMARDs or TNF-inhibitors who initiated treatment with TCZ. Data were collected at the time of TCZ-beginning (baseline visit) and at 2 routine follow-up visits closest to the weeks 12 and 24. The variance of fatigue outcomes relative to associated factors was calculated by multiple regression analysis.

Results: Of 122 patients included, 120 were evaluable (87% female; mean age: 52.2±12.6 years; mean disease duration: 9.1±7.8 years). At baseline: Hb (g/dL), 12.4±1.4; CRP (mg/L), 12.5±16.9; DAS28 score, 5.6±1.0; TJC, 8.6±6.3; SJC, 5.9±4.2; pain (visual analogue scale, cm), 6.7±2.3; morning stiffness duration (hours), 1.3±2.4; FACIT_F fatigue outcome, 23.7±11.1; Beck depression score, 18.5±13.0; Epworth sleepiness score, 6.1±4.5. At 12 and 24 weeks, DAS28 had significantly decreased 2.5±1.1 and 2.7±1.4 points, respectively, fatigue scores had significantly fallen to 19.2±10.6 and 18.8±10.7, and 51% and 61% of patients were good EULAR responders. Significant improvements were also observed in the other RA-related factors evaluated (Table). Sleepiness and depression were significant correlates in the multivariate model explained 35% of the variance in fatigue scores.

Mean changes (SEM) in fatigue outcomes and related factors from baseline
Variable	Week 12	p-value*	Week 24	p-value*
FACIT_F fatigue	-4.7 (0.9)	<0.001	-5.2 (1.0)	<0.001
Serum Hb levels (g/dL)	0.6 (0.1)	<0.001	0.6 (0.1)	<0.001
CRP levels (mg/L)	-10.7 (0.9)	<0.001	-11.2 (2.1)	<0.001
SJC	-3.7 (0.5)	<0.001	-4.1 (0.4)	<0.001
Morning stiffness (hours)	-0.9 (0.3)	<0.001	-1.0 (0.2)	<0.001
Pain VAS (cm)	-2.6 (0.2)	<0.001	-2.7 (0.3)	<0.001
Epworth sleepiness score	-0.6 (0.4)	0.162	-1.0 (0.3)	<0.001
Beck depression score	-3.6 (0.9)	<0.001	-3.9 (1.1)	<0.005
*Based on paired samples t-test. No multiple comparison adjustment was made. Abbreviations: SEM, standard error mean.

Conclusion: Tocilizumab improves fatigue outcomes in patients with RA, a benefit that may be mediated by its effect on disease activity as shown by the reduction of DAS28. Tocilizumab reduces the concentration of acute-phase reactants and improves Hb levels, which can also contribute to decreasing fatigue experienced by RA patients. However, if the improvements observed in morning stiffness duration, pain, and sleepiness and depression scores are the result of the improvement in patient’s fatigue cannot be concluded. Fatigue highly correlates with sleepiness and depression, having these RA-symptoms a significant role in explaining fatigue in RA.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/fatigue-and-related-factors-in-patients-with-rheumatoid-arthritis-treated-with-tocilizumab-in-daily-clinical-setting/