Vectical^® Ointment 3 mcg/g

Indication

Vectical^® Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older.¹

Dosage

Vectical^® Ointment is to be applied to affected areas twice daily, morning and evening. The maximum weekly dose should not exceed 200 grams.¹

Use

Vectical^® Ointment should not be applied to the eyes, lips or face.¹

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Vitamin D₃ agents help regulate differentitation¹

From Wolf K, et al., eds. Fitzpatrick's Dermatology in General Medicine, 7th ed. McGraw-Hill Professional; 2008:172. Reproduced with permission from the McGraw-Hill Companies.³

*Untreated lesion.

Pathogenesis

• In psoriasis, increased rates of proliferation impair terminal differentiation of keratinocytes²
• Hallmarks of altered differentiation in psoriasis include absence of granular layer and parakeratosis in the stratum corneum⁴

Lesion Recurrence

• Expression levels of genes associated with structural cutaneous components and epidermal physiology remain abnormal after the lesion appears to resolve⁵

Vitamin D₃ in the Skin

Regulation of differentiation⁷

• Gene expression in keratinocytes is tightly controlled via interaction between the endogenous active metabolite of Vitamin D₃ (calcitriol) and its receptor, Vitamin D receptor

Topical calcitriol ointment 3 mcg/g has been shown to help restore normal epidermal structure¹

• Effects of treatment with topical calcitriol
• Restoration of granular layer
• Reduced acanthosis and parakeratosis
• Marked reduction in hyperproliferation and normalization of keratinization
• Reduction in inflammatory cells penetrating the epidermal layer

Efficacy With Vectical^® Ointment

 

In a pivotal trial, 34% of patients with mild or moderate plaque psoriasis treated with Vectical^® Ointment achieved treatment success (Global Severity Score [GSS] clear or minimal) at 8 weeks vs 22% with vehicle (P=.005).¹*

• 23.4% of patients demonstrated treatment success and showed a 2-grade improvement in disease severity²

*Data reported from two 8-week, randomized, double-blind, placebo-controlled, Phase 3 studies comparing the efficacy of Vectical^® Ointment BID vs vehicle ointment in patients (N=839) with mild to moderate plaque psoriasis covering up to 35% body surface area. Success was defined as clear or minimal on the GSS of psoriasis. Results from Study 2 are shown.

The adverse events occuring at a rate of 1% or greater in the Vectical^® Ointment treatment group included skin discomfort (3%) and pruritus (1%). Of those subjects who had laboratory monitoring, 24% in the Vectical^® group experienced hypercalcemia; however, elevations were less than 10% above the upper limit of normal.²

Click here for full Prescribing Information for Vectical^® Ointment.

 

In an open-label regimen study patients with moderate to severe plaque psoriasis were treated with Clobex^® (clobetasol propionate) Spray, 0.05%, for 4 weeks followed by Vectical^® Ointment 3 mcg/g for 8 weeks¹*

*This is a multicenter, open-label study of subjects with moderate to severe plaque psoriasis according to the Overall Disease Severity (ODS) scale. Subjects were treated with Clobex^® Spray, 0.05%, twice daily, for 4 weeks and were evaluated using ODS. Those patients who were deemed clear, almost clear, mild or moderate at the 4-week visit were moved to an 8-week treatment phase with Vectical^® Ointment 3 mcg/g twice daily. Subjects who did not meet this criteria were discontinued from the study. The primary efficacy endpoint was ODS improvement of at least 1 grade from baseline at Week 8 or Week 12.^2
†P values were computed from a paired t-test and signal rank test for each post-baseline comparison to baseline.

Patient: 050-007
Individual results may vary.

• All subjects achieved treatment success at Week 8, and 84.1% of subjects had treatment succes after Week 12¹
• At the end of the study, affected BSA remained stable or improved in 98.8% of patients using Vectical^® Ointment¹

AEs deemed possibly, probably or definitely related to treatment included umbilical hernia, application site dryness, application site irritation, application site pain, application site pruritus, application site rash, application site warmth, chest discomfort, application site folliculitis, sunburn, increased blood glucose, gout, headache, keratosis pilaris, psoriasis, skin burning sensation, and urticaria, all of which were resolved with the exception of 1 patient who experienced application site dryness that was still ongoing at the end of the study.²

Click here for full Prescribing Information for Vectical^® Ointment.

Vectical^® Ointment 3 mcg/g is safe to use for up to 52 weeks for subjects with mild to moderate plaque psoriasis

In a 52-week, open-label, single-group trial that included patients (n=324) with up to 35% affected BSA. The primary endpoints in this study evaluated local and systemic safety of Vectical^® (calcitriol) Ointment 3 mcg/g. Safety assessments included monitoring of all adverse events at all follow-up visits as well as monitoring of laboratory parameters such as hypercalcemia and hypercalciuria. Adverse events were recorded at all follow-up visits.^1,2

• The following non-dermatological adverse events occurred at rates greater than 3% over 52 weeks: lab test abnormality (8%), urine abnormality (4%), and hypercalciuria (3.4%).¹ The following dermatological events occurred at events greater than 1% over 52 weeks: pruritus (3.1%), folliculitis (3.1%), irritant dermatitis (1.5%), allergic reactions (1.2%), eczema (1.2%) and new psoriasis lesions (4%)^1,2
• Ten patients experienced hypercalcemia throughout the course of the study, but there was no relation between hypercalcemia and duration of treatment or percentage affected BSA at baseline. One patient experienced hypercalcemia twice throughout the course of the study. No clinically relevant impact on calcium homeostasis was seen in any patient during the study^2,3

Of patients who completed the study³:

• 94% had stable or improved BSA at Week 26 (n=249)
• 98% had stable or improved BSA at Week 52 (n=130)

Significant improvement in affected BSA after 52 weeks of treatment¹

Source: Treatment with calcitriol ointment 3 µg/g for up to 52 weeks resulted in stable or improved plaque psoriasis disease severity. Presented at the 2011 American Academy of Dermatology Meeting 69th Annual Meeting; February 4-8, 2011; New Orleans, LA.
Poster 3365.^3,4

A retrospective analysis evaluated changes in percentage affected BSA from the 52-week safety study. Patients were treated with Vectical^® Ointment for up to 26 weeks with an option to continue up to 52 weeks. There were originally 324 subjects enrolled in the study, but the analysis shown here evaluated only patients who participated in the study for the full 52 weeks (n=130). Reasons for patient dropout throughout the course of the 52-week study included subject request (14.5%), lost to follow-up (4.6%), lack of efficacy (4.0%), AEs (2.5%), protocol violations (0.3%) and pregnancy (0.3%).^2,3 Overall, the majority of patients (73%) had a lower percentage of BSA affected (improved) at Week 52 compared to baseline (n=95/130). 25% of patients experienced no change in percentage of BSA affected (stable) from baseline to Week 52 (n=32/130).

There was a significant difference in the distribution of percent BSA affected at baseline compared with the distribution at Week 52 (P<.001; Cochran-Mantel-Haenszel test).¹

Click here for full Prescribing Information for Vectical^® Ointment.

Vectical^® Ointment vs calcipotriene ointment in sensitive skin areas

*Multicenter, blinded, left-right comparison study of Vectical^® Ointment vs calipotrene ointment in patients with mild to moderate plaque psoriasis evaluated the tolerability, efficacy and global preference of each product in targeted sensitive areas (N=75).

Perilesional erythema, edema and stinging/burning were all significantly less severe in patients treated with calcitriol that those who were treated with calcipotriene. The difference was especially marked for erythema and burning/stinging. No subject had a grade 3 erythema or edema in calcitriol-treated lesions.