Background Disability, alteration in quality of life and fatigue are frequently reported in spondyloarthritis (SpA). Anti-TNF demonstrated clinical efficacy in SpA. However efficacy on patient-reported outcomes (PROs) may differ from medical assessment.
Objectives To assess the impact of anti-TNF on quality of life, disability and fatigue reported by SpA patients.
Methods Design: systematic review and meta-analysis of the literature. Data sources: two authors (SL and YD) independently screened PubMed-Medline, Cochrane library and EMBASE databases until November 2016. Key words: (“Patient reported” OR “quality of life” OR fatigue OR FACIT) AND (spondyloarthritis OR “psoriatic arthritis” OR “ankylosing spondylitis”) AND (anti-TNF OR certolizumab OR etanercept OR adalimumab OR infliximab OR golimumab). Articles selection: randomized controlled trials (RCTs), published in English, assessing efficacy of anti-TNF on PROs, in ankylosing spondylitis (AS), psoriatic arthritis (PsA) or SpA according to the ASAS criteria. Data collected: fatigue assessed by FACIT score, quality of life assessed by Short Form 36 (SF36) mental and physical component or by Health AssessementQuestionnary Disability Index (HAQ). Data analysis: Article quality was evaluated by the JADAD scale. For SF36 and HAQ outcomes, pooled variations at 12 and 24 weeks were computed by meta-analysis. Heterogeneity was measured by I2 index.
Results Of the 604 articles identified, 37 references were eligible for systematic review and 13 for meta-analysis. Our systematic review identified 10 RCTs concerning AS, 20 concerning PsA and 7 concerning axial SpA. However due to the heterogeneity in available statistical data, references eligible for meta-analysis were mainly related to PsA.
HAQ assessment was available for a meta-analysis in 8 studies. HAQ was significantly improved at 12 and 24 weeks with anti-TNF. The impact on HAQ variation at week 24 was -0.29 points [95% CI: -0.37, -0.22]. Heterogeneity was important (I2 =57%; see figure).
Ten studieswere eligible for a meta-analysis of anti-TNF effect on SF36 mental form. An improvement was observed at 12 and 24 weeks, although superior at 24 weeks. The effect at week 24 was 2.78 [95% CI: 1.87 - 3.68], without heterogeneity (I2 =0%; see figure).
Twelve studies were eligible for a meta-analysis of anti-TNF effect on SF36 physical form. We observed a similar and significant improvement at 12 and 24 weeks. The effect at week 24 was 6.74 [95% CI: 5.34 – 8.13], with an important heterogeneity (I2 =84%; see figure)
Fatigue was evaluated in 3 studies. Adalimumab induced a significant improvement in FACIT score at 12 and 24 weeks in one study. Two studies using different scores (Fatigue Assessment Scale, BASDAI fatigue item) to assess certolizumab effect highlighted similar findings: an early improvement in fatigue at week 12, remaining significant and stable at week 24.
Conclusions Anti-TNFs agents significantly improve disability, quality of life and fatigue in patients with PsA.
Acknowledgements Abbvie France pharmaceutical company provided logistic support by organizing a meta-analysis methods workshop, but played no further role in the project.
Disclosure of Interest None declared