Impact of Baseline Disease Severity Over 26 and 52 Weeks of Treatment with Calcitriol Ointment 3µg/g in Patients with Mild-to-moderate Plaque Psoriasis

Abstract

Objective: Calcitriol 3µg/g ointment has been shown to be a safe and effective treatment for adults with mild-to-moderate plaque psoriasis. This analysis evaluated the response to calcitriol 3µg/g ointment relative to baseline disease.

Design: Retrospective analysis of data from a 12-month safety and tolerability trial.

Setting and participants: At baseline, 40.1 percent (130/324) of patients had an affected body surface area of 11 to 20 percent, and 55.2 percent (179/324) had moderate and 25.9 percent (84/324) had severe disease according to global severity score. Patients applied calcitriol 3µg/g ointment twice daily for up to 52 weeks.

Measurements: Change in investigator's global severity scores and involved body surface area at Week 26 (N=249) and Week 52 (N=130) relative to baseline.

Results: Compared with baseline, most patients experienced at least a 1-grade improvement in global severity score at Weeks 26 (195/249, 78.3%) and 52 (109/130, 83.8%). Stabilization (i.e., no change in global severity score) was reported in 19.3 percent (48/249) at Week 26 and in 12.3 percent (16/130) at Week 52. Most patients also experienced at least a 1-grade improvement in body surface area involved at Weeks 26 (152/249, 61.0%) and 52 (95/130, 73.1%). Stabilization (no change in affected body surface area) was reported in 32.5 percent (81/249) at Week 26 and 24.6 percent (32/130) at Week 52. The proportion of patients experiencing improvement in global severity score and body surface area was comparable across all categories of severity and disease extent at baseline.

Conclusion: This analysis suggests that calcitriol 3µg/g ointment use for 26 weeks (N=249) and 52 weeks (N=130) was associated with disease improvement or stabilization in most patients with plaque psoriasis.

Figure 1

Change in global severity score (GSS) from baseline: a) at Week 26 (N=249) and b) at Week 52 (N=130). Improvement is defined as at least a 1-grade lowering of GSS score relative to baseline.

Figure 2

Change in percent body surface area (BSA) involvement from baseline: a) at Week 26 (N=249) and b) at Week 52 (N=130). Improvement is defined as at least a 1-grade lowering of BSA affected relative to baseline. Improvements among patients in the 0–5% BSA group, while possible, were not apparent due to the way data was grouped for this analysis. No patients in the 0–5% BSA group worsened to the next category.