Journal of Clinical and Aesthetic Dermatology

Psoriasis and Cutaneous Supplement 2016

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

Issue link: http://jcadonline.epubxp.com/i/729153

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S 1 0 S U P P L E M E N T T O T H E J O U R N A L O F C L I N I C A L A N D A E S T H E T I C D E R M AT O L O G Y [ S E P T E M B E R 2 0 1 6 • V O L U M E 9 • N U M B E R 9 ] T he c hoi c e shoul d b e b a se d on the i ndi v i dua l pa ti e nt's c ha ra c te ri sti c s a nd ob j e c ti v e s. In othe r words, a pa ti e nt ne e d not "fa i l " photothe ra py b e fore re c e i v i ng a b i ol og i c a g e nt. To p i c a l Tr e a t m e n t s f o r P s o r i a s i s E v e n i n the a g e of b re a kthroug h sy ste m i c a g e nts to tre a t psori a si s, topi c a l the ra py sti l l pl a y s a n i m porta nt rol e i n tha t m a ny pa ti e nts ha v e l oc a l i z e d di se a se or l oc a l i z e d fl a re s. T he re i s c onsi de ra b l e e v i de nc e i n the lite ra ture in support of c la ss I , I I I / I V, V/ VI / VI I c or ti c os te r oi ds , v i ta m i n D a na l og s , ta z a r ote ne , a nd c om b i n a ti on th e r a p y ( c or ti c os te r oi d p l u s v i ta m i n D a na l og or ta z a rote ne ) . 34 Topi c a l ste roi ds a re a v a i l a b l e i n a ra ng e of pote nc y, f rom low ( C la ss VI I ) , suc h a s hy droc orti sone 1% c re a m or oi ntm e nt, to supe r- hi g h- pote nc y produc ts ( C la ss I ) , suc h a s a ug m e nte d b e ta m e tha sone di propi ona te 0. 05% oi ntm e nt or g e l or a l so fl uoc i noni de 0. 1% . T he grea test shi ft i n our thi nki ng a bout topi c a l a gents of l a te ha s been the rol e of the v ehi c l e or c a rri er of the a c ti v e a gent. Ac c ordi ng to the ol d pa ra di gm , a n oc c l usi v e a g e n t ( o i n t m e n t ) w a s n e e d e d t o p r o v i d e t h e b e s t penetra ti on a nd thus effi c a c y, but new types of v ehi c l es a re c ha ngi ng the l a ndsc a pe of topi c a l produc ts. T hese so - c a l l e d " d e si g n e r v e h i c l e s" a l l o w f o r g r e a t e r sk i n penetra ti on whi l e m odul a ti ng perm ea ti on i nto rec eptor fl ui d (bl ood). In tha t wa y, a v ehi c l e m a y i m prov e effi c a c y of the a c ti v e a gent a nd i t m a y m i ni m i ze a dv erse ev ents. Vehi c l es c a n opti m i ze penetra ti on of the a gent, whi c h, i n turn, c a n enha nc e produc t effi c a c y. T he effi c a c y of c a l c i potri ene i s v ehi c l e-dependent. In a s t udy o f c a l c i po t ri e ne , t he o i nt m e nt f o rm ul a t i o n resul ted i n 70-perc ent m a rked i m prov em ent a t ei ght w eek s w i t h 1 1 p er c en t o f p a t i en t s c l ea r a n d s k i n i r r i t at i o n o ccu r r i n g at a r at e o f 1 0 t o 1 5 p er cen t . C a l c i p o t r i en e i n c r ea m fo r m u l a t i o n r es u l t ed i n 5 0 - perc ent m a rked i m prov em ent, four perc ent c l ea r, a nd i rri ta ti on a t 10 to 15 perc ent ov er the sa m e ti m e peri od. Sol uti on reduc ed i rri ta ti on to 1 to 5 perc ent, but wi th a 31-percent marked improvement and 14 percent clearance. Foam calcipotriene resulted in an irritation rate of two percent, 41 percent clear or almost clear on the scalp, and 14 to 27 percent clear or almost clear on the body. Combination or sequential therapy enhances ef f i cacy, m i ni m i zes s i de ef f ects , and m ay o f f e r a s t e r o i d- s pari ng treatm ent f o r m anagi ng ps o ri as i s . I n a t hr e e - arm tri al eval uati ng the ef f i cacy o f co m b i na t i o n t he r a py (cal ci po tri ene o i ntm ent 0 . 0 0 5 % appl i ed m o r ni ng s a nd halobetasol propionate 0.05% ointment evenings) versus calcipotriene ointment 0.005% only applied twice daily versus halobetasol propiona t e o i nt m e nt 0.05% applied twice daily, the study (n=12 7 ) f o und t ha t after two weeks, combination therapy was more effective than the monotherapies (71% o f c o m b i na t i o n p a t i e n t s w e r e c l e a r o r a l m o s t c l e a r a t 1 4 d a y s v e r s u s 57% of h al obetas ol on l y p ati en ts an d 30% of c a l c i p o t r i e n e o n l y p a t i e n t s ) . F e w e r c u t a n e o u s a d v e r s e e f f e c t s w e r e o b s e r v e d i n t h e c o m b i n a t i o n g r o u p t h a n t h e m o n o t h e r a p i e s . 3 5 T h e r a t i o n a l e b e h i n d c o m b i n a t i o n t h e r a p y i n t h i s s t u d y w a s t h a t t h e p a t i e n t c o u l d o b t a i n t h e e f f i c a c y c o n f e r r e d b y s t e r o i d s w h i l e m i t i g a t i n g a s s o c i a t e d r i s k s . In a nothe r study e v a l ua ti ng fi x e d c om b i na ti on of b e t a m e t ha so ne dipro pio na t e / c a lc ipo t rie ne o int m e nt , 1 , 6 0 3 p a t i en t s w i t h c h r o n i c p l a qu e p s o r i a s i s w er e ra ndo m i z e d t o o ne o f f o ur g ro ups: b e t a m e t ha so ne dipropiona te ointm e nt plus c a lc ipotrie ne da ily, b e tame th as on e d i p r op i on ate on l y d ai l y, cal ci p otr i e n e onl y da i l y, or v e hi c l e onl y ( pl a c e b o) . 36 T he c om b i na ti on produc t ( b e ta m e tha sone dipropiona te plus cal ci p o t r i e n e ) w as s i g n i f i can t l y m o r e e f f e ct i ve t h an e i the r m onothe ra py or pl a c e b o a t We e k 1 a nd We e k 4 ( 39. 2% m e a n c ha ng e i n PA SI sc ore a t one we e k a nd 71. 3% a t four we e ks c om pa re d to 33. 3% a nd 57. 2% [ b e ta m e tha sone di propi ona te onl y ] , 23. 4% a nd 46. 1% [ c a l c i potri ene onl y] a nd 18. 1% a nd 22. 7% [ pl a c ebo] ). Of pa rti c ul a r c l i ni c a l rel ev a nc e i n thi s study wa s the ra pi d response, wi th noti c ea bl e i m prov em ent a t one week i n c om bi na ti on thera py. Ma i ntena nc e thera py pl a ys a c ruc i a l rol e i n effi c a c y. In a study of c a l c i potri ene c om bi ned wi th beta m etha sone dipropionate in 885 patie nts w ith scalp psoriasis, pa ti ents were trea ted da i l y unti l they were c l ea r or a l m ost c l ea r; they were then put on a m a i ntena nc e progra m a nd fol l owed for 12 weeks. 37 One group a ppl i ed the produc t twi c e weekl y rega rdl ess of whether they fel t i t wa s needed or not, whi l e the other group wa s a dv i sed to use the produc t onl y a s needed. T hi s study found tha t th e twi ce-weekl y man d ator y ap p l i cati on was mor e effec ti v e a nd a ssoc i a ted wi th a l ower ra te of rel a pse tha n on-dem a nd a ppl i c a ti on onl y (41. 7% v s. 19. 5% , p<0. 001). Our em ergi ng understa ndi ng of the rol e of the v ehi c l e i n topi c a l produc ts a nd desi gner v ehi c l es l ea ds to a n i m porta nt questi on for rea l -worl d c l i ni c a l pra c ti c e. C a n a c osm eti c a l l y a c c epta bl e v ehi c l e be found tha t enha nc es penetra ti on? For i nsta nc e, i t i s known tha t c a l c i potri ene pl us beta m etha sone di propi ona te i s m ore effec ti v e a s a n ointment than a suspension, but the ointment formulation is not cosmetically elegant. A new foam fo rm ul at i o n was desi gned t o enhance effi cacy i n a cosmetically acceptable vehicle. Data show that the aerosol foam combination product (calcipotriene plus betamethasone dipropionate) allowed for better penetration of both active agents (betamethasone dipropionate and calcipotriene) into the skin compared to the ointment in an in vitro porcine skin assay. In a Phase 3 randomized, placebo-controlled study of this same fixed-combination foam product in 426 adult mild- t o-se v e re pla que psoria sis pa t ie nt s (t he P SO-FA ST study), significantly more patients achieved "treatment success" based on PGA score at four weeks with the foam product than placebo at four weeks (53.3% vs. 4.8%, p<0.001). Adverse drug reactions were reported in

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