A post hoc analysis has examined the effects of Adalimumab ( Humira ) in patients with scalp and/or nail psoriasis from BELIEVE, a randomized, controlled, multicentre phase 3 safety and efficacy trial.
Efficacy was assessed in the pooled treatment group ( Adalimumab with or without Calcipotriol plus Betamethasone dipropionate ) by Psoriasis Area and Severity Index ( 75% improvement; PASI 75 ), Psoriasis Scalp Severity Index ( PSSI ), Nail Psoriasis Severity Index ( NAPSI ), Dermatology Life Quality Index ( DLQI ) and a visual analog scale ( VAS ) for pain.
Of the 730 enrolled patients, 663 ( 91.3% ), 457 ( 63.1% ) and 433 ( 60.1% ) had psoriasis of the scalp, nails, or both, respectively. Similar proportions of patients with ( 68.2% ) and without ( 63.5% ) scalp involvement achieved a PASI 75 response at week 16 [ adjusted odds ratio ( OR ), 1.34; P = 0.320 ].
PASI 75 response rates were lower in patients with nail psoriasis compared with patients without nail psoriasis at week 8 ( 53.0% vs 62.9%; OR=0.68; P = 0.019 ) and week 16 ( 65.0% vs 73.0%; OR=0.70; P = 0.052 ).
PASI 75 response rates were 66.1% in patients with scalp and nail involvement and 70.8% in patients without both scalp and nail involvement at week 16 ( OR=0.87; P = 0.423 ).
Patients in all scalp and nail subgroups reported improvements in DLQI and VAS pain scores throughout the study. Patients with scalp psoriasis exhibited large improvements in scalp symptoms demonstrated by a median decrease from baseline PSSI at week 16 of 100%.
Patients with nail psoriasis improved, demonstrated by a median decrease from baseline NAPSI at week 16 of 39.5%.
The results have indicated that Adalimumab improves overall psoriasis and scalp and nail symptoms in this patient population with scalp psoriasis and/or nail involvement.
In addition, similar PASI 75 response rates are achieved in patients with and without scalp involvement, whereas patients with nail involvement have demonstrated a moderate ( perhaps delayed ) PASI 75 response rate. ( Xagena )
Thaçi D et al, J Eur Acad Dermatol Venereol 2014; Epub ahead of print