Predictive factors for switching in patients with psoriatic arthritis undergoing anti-TNFα, anti-IL12/23, or anti-IL17 drugs: a 15-year monocentric real-life study

Abstract

Objectives We aimed to evaluate the (a) potential predictors of first biological disease-modifying anti-rheumatic drug (bDMARD) failure and (b) factors associated with failure of multiple therapies in psoriatic arthritis (PsA). Materials and methods We enrolled consecutive PsA patients attending our unit and undergoing bDMARDs during 2004–2020. Disease characteristics, previous/ongoing treatments, comorbidities, and follow-up duration were recorded. Disease activity and functional and clinimetric scores were recorded at baseline and yearly and were compared between switchers and non-switchers, and within switchers according to the reasons for switching. Effectiveness was evaluated over time with descriptive statistics; multivariate Cox and logistic regression models were used to evaluate predictors of response and failure of multiple bDMARDs. Kaplan–Meier curves were used to assess differences in time-to-first bDMARD discontinuation. Infections and adverse events were recorded. Results Two hundred sixty-four patients were included (117 (44.32%) females, mean age 56 years, mean PsA duration 15 years); 117 (44.32%) switched bDMARDs at least once. Switchers were mostly females, with higher Psoriasis Area and Severity Index and worse Health Assessment Questionnaire at baseline. Mean time-to-first bDMARD discontinuation was 72 months; 2-year and 5-year retention rates were 75% and 60%, respectively. Survival curves for anti-TNFα/anti-IL12/23/anti-IL17 were similar (p = 0.66). Main reasons for switching were inefficacy (67.52%) and adverse events (25.7%). Female sex was associated with a higher risk of first bDMARD discontinuation (HR = 2.39; 95% CI: 1.50–3.81) and failure of multiple bDMARDs (OR = 1.99; 95% CI: 1.07–3.69); initiating therapy before 2015 was protective (HR = 0.40; 95% CI: 0.22–0.73). Conclusions Survival rate was good for anti-TNFα and other bDMARDs. Female sex was a predictor of first bDMARD discontinuation, unlike mechanism of action, comorbidities, and BMI. Key Points• Drug survival in PsA patients was confirmed be greater for the first bDMARD administered.• In case of failure of the first bDMARD, switching/swapping proved a good treatment option, as reflected by a persistent satisfactory effectiveness with second-line bDMARDs and so subsequent switches.• Female sex may constitute a predisposing risk factor for flare and therapeutic switches.• Discontinuation or switching of biologics due to mechanism of action, comorbidities tolerability and BMI did not seem to impact first bDMARD withdrawal.

Effectiveness and safety of secukinumab in axial spondyloarthritis: a 24-month prospective, multicenter real-life study

“…These findings were corroborated by previous studies. 46 – 50 Of note, fibromyalgia was more prevalent in nr-axSpA subjects; the possible reason can be attributed to a higher prevalence (58.3%) of the female gender in the nr-axSpA subgroup.…”

“… 48 , 49 Female axSpA patients more frequently present an entheseal involvement, often compounded by fibromyalgia, which amplifies the perception of pain and fatigue, and therefore negatively impacts the self-reported disease activity. 50 Furthermore, concomitant fibromyalgia may represent a challenge to the therapeutic strategy, since fibromyalgia-associated symptoms can alter the assessment of clinical response to treatments over time. This aspect is very relevant, since in our population a considerable prevalence of fibromyalgia was found (19.3%), mainly in females ( n = 42; 32.3%) versus males ( n = 6; 5.0%).…”

Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies

“…For patients who have active disease despite conventional therapies, biologicals offer greater control of PsA symptoms1 2; however, a substantial proportion of patients experience loss of response over time or are intolerant to certain biologicals. Drug tolerability, safety, patient satisfaction and efficacy influence treatment persistence,4 with lack of benefit being a common reason for switching biologicals 5. Persistent use of biological therapies, which in considerable numbers of patients is driven by treatment efficacy, is associated with better patient outcomes.…”

Patients with psoriasis resistant to multiple biological therapies: characteristics and definition of a difficult‐to‐treat population

“…As for possible predictive factors on the causes of failure and subsequent therapeutic switch, studies in the literature identify smoking, body mass index and female sex as causes 7 . In our population, no statistically significant demographic or disease characteristics were identified, yet the low sample size limits the value of our observations.…”

“…1 As for possible predictive factors on the causes of failure and subsequent therapeutic switch, studies in the literature identify smoking, body mass index and female sex as causes. 7 In our population, no statistically significant demographic or disease characteristics were identified, yet the low sample size limits the value of our observations. Overall, while the available therapeutic armamentarium allows a high number of therapeutic attempts, multi-resistant patients represent an increasing challenge for the clinician.…”