Background: Observational studies in daily practice are an essential complement to pivotal randomised controlled trials because their findings refer to larger and more diverse patient populations with common comorbidities, complex medical history, concomitant medications and longer follow-up periods.
Objectives: To evaluate long-term clinical outcomes of the anti-TNF-α monoclonal antibody, adalimumab, in patients with psoriasis (PsO) or psoriatic arthritis (PsA) referring to an Italian dermatological centre.
Methods: Single-centre retrospective real-world investigation with an observation period of up to 9 years.
Results: We reviewed the records of 316 patients (117 with PsO and 199 with PsA) treated with adalimumab and followed for up to 9 years. Safety and efficacy of adalimumab were consistent with those described in randomised controlled trials (RCTs) and other observational studies. A rapid and sustained improvement of skin lesions (evaluated as Psoriasis Area and Severity Index (PASI) 75, PASI 90 and PASI 100 response rates) was observed in the majority of patients, including those with body mass index (BMI) >30 and with prior experience of biologic therapies (including other anti-TNFs). The safety profile of adalimumab was confirmed also in elderly patients (>65 years).
Conclusion: Our real-life experience shows that the long-term treatment with adalimumab is effective and well tolerated in psoriatic patients, including overweight/obese, elderly and anti-TNF-experienced subjects.
© 2016 European Academy of Dermatology and Venereology.