An Italian shared dermatological and rheumatological proposal for the use of biological agents in psoriatic disease.

BACKGROUND As psoriatic disease (PD) is a condition characterized by the combination of inflammatory skin (psoriasis) and osteo-articular manifestations (psoriatic arthritis), its treatment should cover both its clinical components. OBJECTIVE The objective of this study was to propose a flexible framework for the use of biological agents in PD. METHODS The proposal was drawn up by a group of dermatologists and rheumatologist expert in PD and was based on existing evidence and personal opinion. RESULTS The three TNF-alpha inhibitors (adalimumab, etanercept, infliximab) are effective in all of the psoriatic manifestations and should be used in the case of moderate/severe disease refractory to systemic treatment with non-biological drugs. We propose the following definitions of moderate/severe disease: PASI > 10 or BSA > 10 or DLQI > 10 for plaque-psoriasis; BSA > or = 10 or DLQI > or = 10 for the other psoriatic skin lesions; DLQI > or = 10 or meaningful values of the NAPSI or mNAPSI for psoriatic nail involvement; > or = 1 inflamed joint + patient global VAS(3)4 + physician's judgement or arthritic joint deformities or radiographic joint damage plus > or = 5 inflamed small joints or > or = 1 large joints for peripheral joint involvement; > or = 1 digit with dactylitis and > or = 1 enthesitic sites + patient global VAS(3)4 + physician's judgement for dactylitis and enthesitis. BASDAI > or = 4 + physician's judgement for spondylitis; recurrent flares or risk of developing irreversible damage for uveitis. Other assessment instruments can be used if the physician is more familiar with them and if they have been validated. CONCLUSION We provide a shared dermatological and rheumatological proposal for the use of biological agents in PD.