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)
Paul C, Stein Gold LF, Cambazard F, Kalb RE, Lowson D, Moller AH, Griffiths CE. 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 2016; 175(Suppl 1):213-214.
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.