Effectiveness and safety of secukinumab in 608 patients with psoriatic arthritis in real life: a 24-month prospective, multicentre study.

OBJECTIVES: To evaluate in a multicentric Italian cohort of patients with psoriatic arthritis (PsA) on secukinumab followed for 24 months: (1) the long-term effectiveness and safety of secukinumab, (2) the drug retention rate and minimal disease activity (MDA), (3) differences in the outcomes according to the biological treatment line: biologic-naïve patients (group A) versus multifailure (group B) patients. METHODS: Consecutive patients with PsA receiving secukinumab were evaluated prospectively. Disease characteristics, previous/ongoing treatments, comorbidities and follow-up duration were collected. Disease activity/functional/clinimetric scores and biochemical values were recorded at baseline (T0), 6(T6), 12(T12) and 24(T24) months. Effectiveness was evaluated overtime with descriptive statistics; multivariate Cox and logistic regression models were used to evaluate predictors of drug-discontinuation and MDA at T6. Infections and adverse events were recorded. RESULTS: 608 patients (41.28% men; mean (SD) age 52.78 (11.33)) were enrolled; secukinumab was prescribed as first-line biological treatment in 227 (37.34%) patients, as second (or more)-line biological treatment in 381 (62.66%). Effectiveness of secukinumab was shown with an improvement in several outcomes, such as Ankylosing Spondylitis Disease Activity Score (T0=3.26 (0.88) vs T24=1.60 (0.69) ;p=0.02) and Disease Activity Index for Psoriatic Arthritis (T0=25.29 (11.14) vs T24=7.69 (4.51); p<0.01). At T24, group A showed lower Psoriasis Area Severity Index (p=0.04), erythrocyte sedimentation rate and C reactive protein (p=0.03 ;p=0.05) and joint count (p=0.03) compared with group B. At T24, MDA was achieved in 75.71% of group A and 70.37% of group B. Treatment was discontinued in 123 (20.23%) patients, mainly due to primary/secondary loss of effectiveness, and in 22 due to adverse events. Retention rate at T24 was 71% in the whole population, with some difference depending on secukinumab dosage (p=0.004) and gender (p=0.05). CONCLUSIONS: In a real-life clinical setting, secukimumab proved safe and effective in all PsA domains, with notable drug retention rate.

Sarcopenia in Patients with Rheumatic Diseases: Prevalence and Associated Risk Factors.

The prevalence of sarcopenia in rheumatic diseases has been evaluated in single diseases using various diagnostic approaches, generating conflicting data on the pathogenetic mechanism(s). Herein, we evaluated both muscle mass index (MMI) and muscle strength to assess sarcopenia and presarcopenia in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Moreover, we evaluated the possible impact of disease/patient-related characteristics, therapeutic regimens, and nutritional aspects on sarcopenia. The present study included 168 patients of both genders, aged 40⁻75 years. All patients underwent a nutritional evaluation, physical activity level assessment, rheumatologic evaluation, and an MMI and muscle strength assessment. The prevalence of sarcopenia was about 20% in all the three rheumatologic diseases, whereas presarcopenia was significantly different in RA, PsA and AS (p = 0.006). At multivariate analysis, only age ≥60 years and the presence of a disability were associated with a significantly increased risk of sarcopenia (p = 0.006 and p = 0.01, respectively), while a higher C-reactive protein did not reach statistical significance. Sarcopenia is similar in RA, PsA and AS, whereas presarcopenia significantly differs in these three diseases. Disease activity/inflammation and nutritional aspects do not influence sarcopenia, while age ≥60 years and the presence of a disability significantly increase the risk of sarcopenia.

Obesity reduces the drug survival of second line biological drugs following a first TNF-α inhibitor in rheumatoid arthritis patients.

OBJECTIVES: The aim of this study was to assess whether body mass index (BMI) affects clinical outcomes in rheumatoid arthritis (RA) patients starting a second line biological drug after failure of a first TNF-α blocker. METHODS: From a longitudinal cohort, we analyzed 292 RA patients (66 obese, 109 overweight, and 117 normal-weight) treated with a first ever anti-TNF-α drug. Patients discontinuing the therapy were followed-up if began a second biological drug. Drug survival, by Kaplan-Meier life analysis, and 12 months disease remission based on the 28-joint Disease Activity Score (DAS28) were assessed for either course of biologics. The baseline predictors of clinical outcomes were assessed by Cox regression analysis. RESULTS: Survival of the first anti-TNF-α drug was lower in obese (39.4%) than in normal-weight (49.1%) patients, but the difference was not statistically significant. Obese patients had the highest hazard to discontinue the first anti-TNF-α drug (HR 1.64, 1.02-2.62 95% IC, P=0.04), and the lowest percentage of DAS28-based disease remission at 12 months (P=0.04). In 97 (37 normal-weight, 36 overweight, 24 obese) patients who started a second non-anti-TNF-α biological drug, persistence on therapy was significantly lower in obese (43.5%) than in normal-weight (80%, P=0.04) group, and again obesity significantly predicted drug discontinuation (HR 2.9, 1.08-8.45 95% IC, P=0.04). Significantly, less obese patients attained a disease remission (12%, P=0.004) at 12 months. CONCLUSION: Our study provides evidence that obese RA patients poorly respond to second line non-anti-TNF-α drugs after failure of a first TNF-α inhibitor.