RESUMO
BACKGROUND: Filgotinib (FIL) is a selective JAK1 inhibitor with an affinity 30-fold higher than JAK2, approved to treat moderate to severe active rheumatoid arthritis (RA), in adults with inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). METHODS: We conducted a retrospective, multicentric study in order to evaluate efficacy and safety of FIL 200 mg daily therapy, after 3 and 6 months, in 120 patients affected by RA, managed in Tuscany and Umbria rheumatological centers. The following clinical records were analyzed: demographical data, smoking status, previous presence of comorbidities (Herpes zoster -HZ- infection, venous thromboembolism -VTE-, major adverse cardiovascular events -MACE-, cancer, diabetes, and hypertension), disease duration, presence of anti-citrullinated protein antibodies (ACPA), rheumatoid factor (RF), number of biological failures, and prior csDMARDs utilized. At baseline, and after 3 (T3) and 6 (T6) months of FIL therapy, we evaluated mean steroid dosage, csDMARDs intake, clinimetric indexes (DAS28, CDAI, HAQ, patient and doctor PGA, VAS), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and body mass index (BMI). RESULTS: At baseline, the mean disease duration was 9.4 ± 7.5 years; the prevalence of previous HZ infection, VTE, MACE, and cancer was respectively 4.12%, 0%, 7.21%, and 0.83%, respectively. In total, 76.3% of patients failed one or more biologics (one biological failure, 20.6%; two biological failures, 27.8%; three biological failures, 16.5%; four biological failures, 10.3%; five biological failures, 1.1%). After 3 months of FIL therapy, all clinimetric index results significantly improved from baseline, as well as after 6 months. Also, ESR and CRP significatively decreased at T3 and T6. Two cases of HZ were recorded, while no new MACE, VTE, or cancer were recorded during the observation time. CONCLUSION: Despite the limitations of the retrospective study and of the observational period of only 6 months, real-life data on the treatment of RA patients with FIL demonstrate that this Jak inhibitor therapy is safe in terms of CV, VTE events, and occurrence of cancer, and is also effective in a population identified as "difficult to treat" due to failure of previous b-DMARD therapy.
RESUMO
The need for a global assessment of the health state of patients affected by psoriatic arthritis (APs) which takes into account not only bio-clinical aspects but also other relevant results such as physical, mental and social wealth, was the main reason for the development of an original questionnaire capable of assessing the social and psychological impact of both the affections [psoriasis (Ps) and APs] considered individually and in their summing up of effects. Our study assessed 56 consecutive patients affected by APs under treatment in the Medical and Skin Disease Departments of the "Santa Maria" Perugia University Hospital of Terni, within a time span of 14 months. A questionnaire divided in five parts (a general part and four special parts, assessing, psychological, social, rheumatological and social, economic and therapeutic issues) was proposed to each patient under observation. The questionnaire can be self-filled in by the patient more than once and has been statistically validated for internal consistency, reproduciability and comparability with control groups. The patients with APs consider "bad" their diseases (50%) and develop depression (50%); the social life are troubled by Ps (49%) alone, in comparison with APs (22%); 70% of patients agrees with therapy and is willing to sustain an extra-expense of 500 euro per year.