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. 2007 Mar 31;2(1):51–62.

Table 5.

Effect of etanercept on patient-reported outcomes in patients with psoriasis

Level of evidence Reference Design Treatment Outcomes
1a Singh et al. 2004; van der Kerkhof et al. 2004b R, DB, PC, 12-week study involving 1187 patients ETN 25 mg, 50 mg biw, or PLA OR for achieving a clinically meaningful improvement on DLQI:

  • 4.20 (95% CI 3.14, 5.63) and 5.87 (95% CI 4.25, 8.10) for ETN 25 mg and 50 mg, respectively, vs PLA (P<0.0001)


Mean improvement in DLQI at 12 weeks:

  • 51% (95% CI 44.6, 58.1) and 59.1% (95% CI 51.6, 66.6) for ETN 25 mg and 50 mg, respectively, vs PLA (P<0.0001)
1a Strober et al. 2004 R, DB, PC, 12-week study involving 415 patients ± previous systemic or phototherapyb ETN 25 mg biw Percentage improvement in DLQI:

  • 60 vs 54% (NS) for patients and without previous systemic or phototherapy at 12 weeks

  • 64 vs 61% (NS) for patients and without previous systemic or phototherapy at 24 weeks
2 Leonardi et al. 2003 R, DB, PC, 24-week study involving 672 patients ETN 25 mg qw (low dose), 25 mg biw (medium dose), 50 mg biw (high dose), or PLA for 12 weeks Percentage improvement in DLQI:

  • 47.2, 50.8, and 61.0% in low-, medium-, and high-dose groups vs 10.9% for PLA (P<0.0001) at 12 weeks

  • 54.0, 59.4, and 73.8% in low-, medium-, and high-dose groups


PtGA scores improved significantly in all ETN groups vs PLA (P<0.001)
2 Krueger 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 DLQI at 12 weeks:

  • Total score improved by 65–70% for ETN vs 6% for PLA (P<0.0001)

  • Clinically meaningful improvements in DLQI achieved by 72–77% for ETN vs 26% for PLA (P<0.0001)

  • All 6 subscales were significantly improved by ETN more than PLA; greatest effects on symptoms and feelings (ETN 60–62% vs PLA 6%; P<0.0001), and daily activities subscale (ETN 56–62% vs 1% PLA; P<0.0001)


SF-36 at 12 weeks

  • Mean physical component score was 52.7–52.8 for ETN vs 49.6 for PLA (P<0.01)

  • Mean mental component score was 50.6–51.0 for ETN vs 46.5 for PLA (P<0.01)

  • All 8 subscales were significantly improved by ETN more than PLA; greatest effects on bodily pain (ETN 6.2–7.1 vs PLA 1.1; P<0.0001), and social function (ETN 3.9–6.0 vs PLA 0.5; P<0.0001)
2 Tyring et al. 2006 R, DB, MC, PC, 12-week study involving 618 patients followed by an 84-week OL active treatment period ETN 50 mg biw, or PLA Improvements in DLQI at 12 weeks:

  • 69.1% with ETN vs 22.1% with PLA (P<0.0001)


Depression assessed at 12 weeks:

  • Mean difference in improvement in BDI between ETN and PLA was 1.8 (95% CI: 0.6, 2.9) (P<0.0001)

  • Mean difference in improvement in Ham-D between ETN and PLA was 1.2 (95% CI: 0.4, 1.9) (P<0.0001)


Fatigue assessed at 12 weeks:

  • Mean difference in improvement in FACIT-F between ETN and PLA was 3.0 (95% CI: 1.6, 4.5) (P<0.0001)
2 Cassano et al. 2006 R, DB, 12-week study involving 101 patients ETN 50 biw Mean improvement in DLQI: 68%
ETN 100 qw Mean improvement in DLQI: 66%
3a Elewski et al. 2005 12-week OL extension of ETN phase III studies involving 265 patients ETN 25 mg biw switched to 50 mg qw for 12 weeks in OL extension Mean DLQI score at start of OL (3.13) was maintained by switch to ETN 50 mg (3.03)
a

Abstract.

BDI, Beck Depression Inventory; biw, twice weekly; CI, confidence interval; DB, double-blind; DLQI, Dermatology Life Quality Index; ETN, etanercept; FACIT-F, functional assessment of chronic illness therapy—fatigue; Ham-D, Hamilton rating scale for depression; NS, nonsignificant; OL, open-label; OR, odds ratio; PC, placebo-controlled; PLA, placebo; PtGA, Patient’s Global Assessment of psoriasis; R, randomized; SF-36, Short Form-36 Health Survey; qw, once weekly.