- Long-term analysis of 18 clinical trials reveals similar safety of adalimumab (Humira) compared with earlier analyses in patients with moderate to severe chronic plaque psoriasis.
Why this matters
- This study lends further support to the long-term safety of adalimumab and includes 5 new trials since a 2009 safety analysis.
- There were 16,536 total adverse events (AEs), equivalent to 304.6 events per 100 patient-years (E/100 PYs).
- 3798 AEs (70.0 E/100 PYs) were related to adalimumab as assessed by an investigator.
- 269 AEs (5.0 E/100 PYs) led to discontinuation.
- The most common AEs were nasopharyngitis (23.7 E/100 PYs), upper respiratory infection (12.9 E/100 PYs), and headache (7.9 E/100 PYs).
- Serious AEs occurred at a rate of 8.4 E/100 PYs, while serious infections occurred at a rate of 1.8 E/100 PYs.
- The incidence of nonmelanoma skin cancer was elevated in adalimumab patients (standardized incidence ratio, 1.55; 95% CI, 1.10-2.13).
- 3723 patients with moderate to severe plaque psoriasis from 18 clinical trials who received adalimumab were analyzed for treatment-emergent AEs from first dose to 70 days after last dose or study cutoff date.
- Funding: AbbVie Inc.
- Lack of long-term comparator group.