Apremilast ( Otezla ), a specific inhibitor of phosphodiesterase 4, modulates pro-inflammatory and anti-inflammatory cytokine production.
Apremilast's effect on patient-reported outcomes ( PROs ) in patients with moderate to severe psoriasis was evaluated in a phase IIb randomized, controlled trial ( NCT00773734 ).
In this 16-week, placebo-controlled study, 352 patients with moderate to severe plaque psoriasis received placebo or Apremilast ( 10, 20, or 30 mg BID ).
PROs included Dermatology Life Quality Index ( DLQI ), pruritus visual analog scale ( VAS ), and Short-Form Health Survey ( SF-36 ) to assess health-related quality of life ( HRQOL ).
Changes from baseline and patients reporting improvements greater than or equal to minimum clinically important differences ( MCID ) were analyzed.
Correlations between changes across various PRO instruments were explored.
Baseline DLQI ( more than 10 points ) and SF-36 MCS and domain scores indicated impairments in HRQOL.
At 16 weeks, greater improvements from baseline in DLQI scores were reported with Apremilast 20 ( -5.9 ) and 30 mg BID ( -4.4 ) compared with placebo ( 1.9; P less than or equal to 0.005 for both ), and a greater proportion of patients reported improvements greater than or equal to MCID ( 20 mg BID, 49.4%, 30 mg BID, 44.3% ) versus placebo ( 25.0%; P less than 0.04 ).
Greater improvements from baseline in pruritus VAS scores were reported with Apremilast 20 ( -35.5% ) and 30 mg BID ( -43.7% ) versus placebo ( -6.1%; P less than or equal to 0.005 ).
Significant and clinically meaningful improvements in SF-36 mental component summary scores ( P less than or equal to 0.008 ) and Bodily Pain, Mental Health, and Role-Emotional domains were reported with all Apremilast doses ( P less than 0.05 ), and Social Functioning with 20 and 30 mg BID ( P less than 0.05 ) and Physical Functioning with 20 mg BID ( P less than 0.03 ).
Correlations between SF-36 scores and DLQI were moderate ( r more than 0.30 and less than or equal to 0.60 ) and low between SF-36 and pruritus VAS ( r less than or equal to 0.30 ), indicating they measure different aspects of the disease.
In conclusion, Apremilast treatment resulted in improved HRQOL, including DLQI and pruritus VAS over 16 weeks of treatment, in patients with moderate to severe psoriasis. ( Xagena )
Strand V et al, Health Qual Life Outcomes 2013;11:82. doi: 10.1186/1477-7525-11-82.