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Abstract
Background Fatigue is an important aspect of disease both in rheumatoid arthritis (RA) and in psoriatic arthritis (PsA) and is of high priority for patients. In RA, a recent Cochrane meta-analysis found a small effect of biologics on fatigue (standardized mean difference, SMD, 0.43; 95% confidence interval, CI: 0.38–0.49).(1) Little is known about this effect in PsA.
Objectives To assess the effect of biologics on fatigue in PsA randomised controlled trials (RCTs) and to compare this effect with the effect in the same trials, on pain, through a systematic literature review (SLR) and meta-analysis (MA).
Methods SLR up to January 2017 in PubMed, Embase and Cochrane trials database and in recent congress abstracts, using key words related to PsA and biologics. All RCTs in PsA of any biologic therapy, assessing fatigue (whatever the score used), with data available for fatigue were included. Data were collected by 2 regarding levels of fatigue (6 trials used FACIT, 1 VAS) and pain (if available) at baseline and at the timepoint closest to 24 weeks after the biologic introduction. A MA was performed using RevMan and SMDs were calculated for each trial and each study dose, for fatigue and for pain. A SMD <0.5 is usually considered small, between 0.5 and 0.8 moderate and >0.8 as important.
Results After screening 295 publications, 7 RCTs were included in the meta-analysis and assessed TNF blockers (N=3: adalimumab N=2, certolizumab pegol, N=1), secukinumab (N=2), apremilast (N=1) and ustekinumab (N=1) with or without methotrexate, compared to placebo. The studies included 2340 PsA patients: weighted mean age ± standard deviation (SD), 48.7±1.3 years, disease duration 7.7±1.3 years, 53.3% were females. At baseline, joint disease activity was high (weighted mean swollen joint count: 13.0±3.1, HAQ-DI: 1.2±0.1, PASI: 10.4±3.3). Fatigue levels were high at baseline (weighted mean FACIT score: 29.2±1.5). The pooled SMD for fatigue was 0.44 (95% CI -0.35, 0.54) and it ranged 0.04 to 0.71 across drugs and trials with a small to moderate effect (Graph). In 6 of the same studies, the pooled SMD for pain was 0.62 (95% CI 0.52, 0.73) and ranged 0.46 to 0.84.
Conclusions Biologics had a mild to moderate effect on fatigue at 24 weeks in PsA RCTs. No notable differences across drugs were apparent. Effect sizes were higher on pain with a moderate effect. This effect seems similar to effects noted in RA in the Cochrane meta-analysis (1).These results confirm fatigue may be multifactorial in PsA; biologics bring some improvement at the group level but other treatment modalities should be further explored also.
References
Almeida C, Choy EHS, He wlett S, Kirwan JR, Cramp F, Chalder T, Pollock J, Christensen R. Biologic interventions for fatigue in rheumatoid arthritis. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No. CD008334. DOI:10.1002/14651858.CD008334.pub2.
References
Disclosure of Interest None declared