Objectives. The primary aim of our study was to evaluate long-term efficacy of secukinumab (SCK) in patients with axial spondyloarthritis (axSpA); secondary aims were to evaluate drug retention rate and to identify differences in the clinical and laboratory assessment according to axSpA clinical features, dosage administered, and biologic treatment lines. Patients and Methods. We collected clinical, demographical, and treatment data from 39 patients affected by axSpA consecutively treated with SCK. Laboratory assessment was based on inflammation parameters; clinical assessment was performed with the Ankylosing Spondylitis Disease Activity Score- (ASDAS-) CRP and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Data were recorded at baseline and every 3 months for the first year and then every 6 months in the second year. Results. Twelve males and 27 females were enrolled; both BASDAI and ASDAS-CRP showed a statistically significant reduction during the observation period (p<0.0001 and p<0.0001, respectively). C-reactive protein significantly decreased (p=0.006), with significant reduction at the post hoc analysis between baseline and both 6-month evaluation (p=0.02) and 24-month visit (p=0.036). No statistical significance was observed in BASDAI and ASDAS-CRP improvement (p=0.482 and p=0.164, respectively) between different dosages administered. No significant differences emerged in the BASDAI and ASDAS-CRP variations between biologic-naïve patients and subjects previously failing to tumour necrosis factor (TNF) inhibitors (p=0.53 and p=0.148, respectively). At the end of our observation, 7 out of 39 patients discontinued SCK. The global retention rate at the end of the study period was 78.2%, without any significant differences between biologic-naïve and anti-TNF-failure patients (p=0.619) or between subjects administered with different SCK dosages (p=0.614). No adverse events were reported. Conclusions. In our cohort, SCK has proved a remarkable effectiveness regardless biologic treatment line and dosages employed. As suggested by the notable drug retention rate, SCK has been able to maintain its effectiveness over a considerable long period of treatment.
BackgroundIL-6r targeting therapy has been proven to be effective and safe in Giant Cell arteritis (GCA) as well in Takayasu arteritis (TA) in RCTs, probably because of the similar pathologic findings and vessel size (Large Vessel Vasculitis, LVV). However, real world data are scarce.ObjectivesThe aim of the study was to evaluate the effectiveness of Tocilizumab for LVV in real life settings.MethodsWe retrospectively evaluated, from 2011 to 2017, the outcomes (including glucocorticoid dosage) in patients affected by LVV (according to 1990 aCR classification criteria) who received 8 mg/kg iv Tocilizumab (TCZ) monthly, due to the inadequate response to immunosuppressant. Demographic and clinical characteristics and laboratory findings were collected at baseline and consecutive follow up visits, over 52 weeks. Statistical analysis was performed using the GraphPad Software ver. 6.0 (San Diego CA USA) using appropriate tests.ResultsWe analyzed n.10 patients (6/10 GCA, 4/10 TA) with mean age (± SD) 56 ± 21 years and mean disease duration 41±38 months. Eight out of 10 patients were female. Over the entire observation period, 7/10 also received concomitant methotrexate (mean dose 12.8 ± 2.7 mg/week) while 2/10 received azathioprine (100 mg/day). Median (IQR) prednisone equivalent dose at baseline was 22.5 (10-25) mg/day. At baseline, median ESR was 49 (31-58) mm/h and median CRP level was 15.4 (1.95-28.53) mg/l. Upon TCZ treatment we observed a good disease control in absence of headache, fever and other LVV clinical signs through 52-week follow up. At 52 weeks, we observed a significant reduction of ESR down to 6.5 (2.75-12.25) mm/h as well as of CRP level, down to 1.5 (0.67-3.47) mg/l (p<0.001). A meaningful steroid sparing effect was also achieved as a significant reduction in prednisone dose down to 5 (1.87-6.25) mg/day (p<0.001). During the 52-week follow up period, 3 patients discontinued TCZ treatment for side effects: 1 for severe neutropenia (at 12 weeks), 1 for hemorrhagic pancreatitis (after 24 weeks), and 1 for diverticulitis (after 52 weeks).ConclusionIn our real life experience iv TCZ was effective and safe in LVV treatment, with a good disease control and a significant steroid-sparing effect. Our preliminary findings need to be confirmed in larger cohorts and prolonged follow-up.References[1] Stone JH, Tuckwell K, Dimonaco S, Klearman M, aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Schett G, Schulze-Koops H, Spiera R, Unizony SH, Collinson N. Trial of Tocilizumab in Giant-Cell arteritis. N Engl J Med. 2017Jul27;377(4):317-328. doi: 10.1056/NEJMoa1613849. PubMed PMID: 28745999.Disclosure of interestsgiulia righetti: None declared, vincenzo venerito: None declared, maria giannotta: None declared, Giuseppe Lopalco Speakers bureau: SOBI, BMS, margherita giannini: None declared, Fabio Cacciapaglia: None declared, Laura Coladonato: None declared, Florenzo Iannone Consultant for: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, abbVie, MSD, BMS, Novartis,...
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