Abstract

Background:bDMARDs have an effect on glucose homeostasis (1), lipoproteins profile (2; 3) and blood pressure (4). However, with the exception of obesity (5; 6), there are no clear data on how bDMARDs work in patients who already have or develop metabolic comorbidities and whether these conditions can impact on their efficacy and safety profile.Objectives:to evaluate, in chronic inflammatory joint diseases, the effect of arterial hypertension (AH), dyslipidemia (DYS) and diabetes mellitus (DM) on efficacy, safety and retention rate of first-line bDMARDs therapy.Methods:a retrospective observational study on the clinical charts of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS), treated with first on-label bDMARD was performed. Data on adverse events, efficacy and comorbidities at the baseline visit in which the bDMARD was prescribed (BL), the visit performed after 6 months of therapy (6M), and the last visit on treatment (LoT) were collected.Results:383 patients (41,8% RA, 33,4% PsA and 24,8% AS) were included in the study, with the predominance of females (F: 67,36%, M: 32,64%; mean age 51,67 ± 15,11 years). Our data show that the presence of comorbidities had no influence on efficacy of bDMARD, while patients who had DYS at BL manifested a higher rate of systemic adverse events either in the first 6 months of therapy (58,9% vs 43,7%, p=0,040) and also later on (80,36% vs. 66,67%, p=0,046). In addition, patients who developed DYS and AH after the 6M visit reported a higher rate of systemic adverse events at LoT visit, compared to others (DYS: 97,8% vs 66,7%, p<0,001; AH: 86,9% vs 65,2%, p=0,031). For what concerns the retention rate, patients who developed DYS or AH during bDMARD treatment continued the drug for a longer period of time (DYS 95,5 vs 19,6 months, p<0,001; AH 72,1 vs 23,4 months, p<0,001). In particular, patients with AH who concomitantly carried out therapy with ACE-inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) continued bDMARDs for nearly 20 more months than patients who were not exposed to these drugs (40,5 vs 23,4 months, p=0,001) and more frequently maintained the bDMARDS at LoT (59,42% vs. 47,53%). In case of withdrawal in the ACEi/ARB exposed cohort, this was due to well-being and disease remission rather than inefficacy or adverse reaction (p=0,025). In dyslipidemic patients treated with statins, data showed that bDMARDs were continued for a longer time than in DYS patients treated with other anti dyslipidemic therapies (41,09 vs. 26,50 months, p=0,042).Conclusion:our data suggest that AH and DYS may be associated with higher frequency of adverse events but a better drug retention. The combination of bDMARD and ACEi/ARB may determine a better control of the inflammatory process by inhibition of angiotensin II, favouring the achievement of remission. In AH patients on bDMARDs, ACEi and ARB could therefore represent an useful anti-hypertensive drug choice. Similarly, statins could be the treatment of choice in DYS patients.

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