שיפור במחלת ההידרדניטיס סופורטיבה ובאיכות החיים בחולים המטופלים באדאלימומאב: תוצאות עולם אמיתי ממחקר ה HARMONY

Background

Real-world effectiveness of adalimumab and its impact on quality of life (QoL) in patients with moderate to severe HS is not well characterized.

Objective

The primary objective of the study was to estimate the effectiveness of adalimumab treatment on disease severity in a real-world setting.

Methods

In a prospective multicenter observational study, we investigated the effect of routine treatment with adalimumab on disease severity, pain, QoL, and work productivity over 52 weeks. Primary effectiveness variable was the proportion of patients achieving HiSCR (at least a 50% reduction in abscess and inflammatory nodule count with no increase in abscess or draining fistula) at week 12.

Results

Two hundred and one patients (51% male, mean age 37 years) were included; 74% had a comorbidity. A total of 132 (70%) patients achieved HiSCR at week 12. Significant improvements in pain (P<.0001) and Dermatology Life Quality Index scores (P<.0001) observed at week 12 were maintained through week 52. Significant improvements in other QoL and work productivity variables observed at week 12 were also maintained through week 52. During the 52 weeks, 27 serious adverse events were reported (21 hospitalizations and 6 interventions). There was 1 death (bladder cancer). Fifteen patients discontinued study medication due to an adverse event.

Conclusions

In a real-world setting, adalimumab decreases disease severity and pain, and improves QoL in patients with moderate to severe HS.