ABSTRACT: BACKGROUND: Biologics have changed the way we treat moderate to severe psoriasis. Clinical trials for these patients offer the chance for those suffering from psoriasis to volunteer their time for the advancement of science while possibly gaining benefit from the efficacy of these medications.
OBJECTIVE: All clinical trials have an ending by study design. In the past, trials ended abruptly but it is more common now for transitioning to the approved or another biologic to be offered. Sometimes, study subjects leave clinical trials suddenly for reasons of lack of efficacy, safety, withdrawing consent, being lost to follow-up, or personal reasons. Presenting early experience in transitioning is important for clinicians.
METHODS: A retrospective case series of 11 patients who were exposed to brodalumab from clinical trials that ended abruptly and transitioned to secukinumab is presented.
RESULTS: This is an early descriptive experience of transitioning between two IL-17 antagonists.
LIMITATIONS: A small number of patients were available and a short follow up limited the data presented.
CONCLUSION: Transitioning between two IL-17 antagonists is an option for those patients requiring such a change.
J Drugs Dermatol. 2016;15(8):941-943. more
ABSTRACT: BACKGROUND: Topical corticosteroids (TCS) are typically used for extended periods of time for chronic skin conditions, including psoriasis. Chronic TCS use may result in side effects similar to those of systemic corticosteroids. Patients may have subclinical adrenal suppression and be unaware of their risk in the case of serious trauma.
OBJECTIVE: The objective of this study was to investigate the real world effects of chronic TCS use and its effects on adrenal suppression in a chronic disease such as psoriasis.
MATERIALS: This retrospective study utilized data from screening visits of a psoriasis clinical trial in which subjects had been on chronic TCS.
RESULTS: In this study, subjects with moderate to severe psoriasis affecting 16-20% of total body surface area (BSA) and using high-potency TCS at screening had a lower post-cosyntropin cortisol level (18.83 mcg/dL) compared to those with moderate psoriasis involving 10-15% of total BSA and using lower potency TCS at screening (23.22 mcg/dL; P=0.03). Both subject groups had lower post-cosyntropin cortisol levels compared to normal, healthy adults (P<0.001 for both).
CONCLUSION: This suggests that real world chronic use of high potency TCS over a larger BSA may result in silent adrenal suppression.
J Drugs Dermatol. 2016;15(8):945-948. more
ABSTRACT: BACKGROUND: Calcipotriene 0.005% (Cal)/betamethasone dipropionate 0.064% (BD) aerosol foam was developed as a new treatment option for patients with psoriasis. This pooled analysis evaluated the efficacy of this formulation for 4 weeks of treatment.
METHODS: Patients aged ≥18 years with mild–severe psoriasis were enrolled into three Phase II/III studies (nCT01536886, nCT01536938, nCT01866163); each study evaluated Cal/BD aerosol foam versus different comparators. Endpoints included: proportion of patients clear/almost clear with ≥2-step improvement in physician's global assessment of disease severity (‘treatment success’); modified (excluding head) psoriasis area and severity index (mPASI); proportion of patients with ≥75% reduction in mPASI (PASI75); change in itch (according to visual analog scale [VAS]).
RESULTS: 1104 patients were included in the pooled analysis: Cal/BD aerosol foam (n=564), Cal/BD ointment (n=135), BD aerosol foam (n=101), Cal aerosol foam (n=101), aerosol foam vehicle (n=152), ointment vehicle (n=51). At week 4, 51% of Cal/BD aerosol foam patients achieved treatment success, a higher proportion than in all other groups (Cal/BD ointment, 43%; BD aerosol foam, 31%; Cal aerosol foam, 15%; aerosol foam vehicle, 5%; ointment vehicle, 8%). Greater percentage mean decrease in mPASI with Cal/BD aerosol foam was noted versus other treatments at week 4 (72% vs 63%, 53%, 43%, 32%, and 33%, respectively); week 4 PASI75 rate was also greater (51% vs 41%, 34%, 18%, 7%, and 10%, respectively). Cal/BD aerosol foam was efficacious irrespective of baseline disease severity and on all body areas assessed (arms, legs, trunk). Cal/BD aerosol foam alleviated itch as early as week 1 (change in itch VAS: –30 mm), maintained to week 4 (change in itch VAS: –41 mm).
CONCLUSIONS: Cal/BD aerosol foam was significantly more effective than Cal/BD ointment and the individual active ingredients for treating psoriasis vulgaris, resulting in greater and faster reduction in disease severity and rapid, effective relief of itch.
J Drugs Dermatol. 2016;15(8):951-957. more