More rapid improvement in quality of life with fixed-combination calcipotriene plus betamethasone dipropionate aerosol foam vs. topical suspension (PSO-ABLE study in patients with psoriasis vulgaris)
Br J Dermatol
The phase III, PSO-ABLE study demonstrated superior efficacy with fixed-combination calcipotriene 0.005% (Cal)/betamethasone dipropionate 0.064% (BD) aerosol foam at week 4 vs. Cal/ BD topical suspension at week 8, with comparable safety up to week 12, in patients with mild-to-severe psoriasis of the body. Changes in health-related quality of life (HRQoL) are presented here. Patients assessed HRQoL using Dermatology Life Quality Index (DLQI) and generic EQ-5D questionnaires at baseline, and at weeks 4, 8 and 12. A DLQI score of 0 (range 0-30) and EQ-5D utility score of 1 (weighted range -0.594 to 1) indicate perfect health. The proportion of patients who achieved a DLQI score of 0/1 (no/low impairment) was also determined. In total, 463 patients were randomized (4: 4: 1: 1) to treatment with once-daily Cal/BD foam (n = 185), Cal/BD suspension (n = 188), foam vehicle (n = 47) or suspension vehicle (n = 43). Mean baseline DLQI scores were 7.0 (Cal/BD foam), 7.9 (Cal/BD suspension), 7.0 (foam vehicle) and 9.3 (suspension vehicle), indicating a moderate impact on HRQoL. DLQI scores improved by week 12 in all groups; the mean change in DLQI at week 4 was significantly greater with Cal/BD foam than with Cal/BD suspension (-4.3 vs. -3.8; adjusted difference -1.0; P < 0.01); differences were not significant at weeks 8 (-4.5 vs. -4.4; adjusted difference -0.7; P = 0.07) and 12 (-4.6 vs. -4.3; adjusted difference -0.8; P = 0.07). DLQI score improvements were significantly greater with both active treatments vs. their respective vehicles at each time point (P < 0.05). Significantly more patients using Cal/BD foam than Cal/BD suspension achieved DLQI scores of 0/1 at weeks 4 (46 vs. 32%; P = 0.01) and 12 (61 vs. 44%; P < 0.01), with a nonsignificant difference at week 8 (54 vs. 43%; P = 0.06). Mean baseline EQ-5D utility scores were 0.80 (Cal/BD foam), 0.82 (Cal/BD suspension), 0.82 (foam vehicle) and 0.77 (suspension vehicle). At week 4, a significantly greater improvement in mean EQ-5D utility score was seen with Cal/BD foam vs. Cal/ BD suspension (0.09 vs. 0.03; adjusted difference 0.05; P < 0.01). From week 8, improvements in utility scores for both Cal/BD formulations were comparable (week 8: 0.08 vs. 0.05; adjusted difference 0.03; P = 0.06; week 12: 0.07 vs. 0.05; adjusted difference 0.02; P = 0.21). Both active treatments had significantly greater week 4 improvements in EQ-5D utility scores vs. their respective vehicles (P < 0.05). In PSOABLE, Cal/BD aerosol foam improved HRQoL more rapidly than Cal/BD topical suspension in patients with psoriasis vulgaris.