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. 2007 Mar 31;2(1):51–62.

Table 6.

Tolerability of etanercept in patients with psoriasis

Level of evidence Reference Design Treatment Tolerability outcomes
1a Gottlieb et al. 2004b R, DB, PC, 12-week study involving 1347 patients ETN 25 mg, 50 mg biw, or PLA

  • ISR (low grade) was 14% for ETN vs 6% for PLA after 12 weeks. The rate in the ETN group was lower than that seen in ETN studies in patients with RA (37%)

  • 1.8% ETN- vs 2% of PLA-treated patients discontinued treatment after AEs

  • SAEs reported in 1.7% ETN- vs 1.2% in PLA-treated patients

  • Serious infections requiring hospitalization occurred in 0.3% of ETN- vs 1.2% of PLA-treated patients
2 Papp et al. 2005 R, DB, PC, 24-week study (OL phase during weeks 13–24) involving 583 patients ETN 25 mg or 50 mg biw, or PLA for 12 weeks. All patients received ETN 25 mg biw during OL phase ISR (all mild or moderate) was the most commonly reported event:

  • 16% of ETN- vs 6% of PLA-treated patients after 12 weeks

  • 4% of ETN- vs 10% of PLA-treated patients after 24 weeks
a

Abstract.

AE, adverse event; biw, twice weekly; DB, double-blind; DLQI, Dermatology Life Quality Index; ETN, etanercept; ISR, injection site reaction; OL, open-label; PC, placebo-controlled; PLA, placebo; R, randomized; RA, rheumatoid arthritis; SAE, serious adverse event.