Disease Treatment Goals Research Articles

P288 Application of a new classification of Fistulizing Perianal Crohn’s Disease (FPCD) in clinical practice: evaluating the correlation between clinician and patient’s assessments and FPCD patient′s quality of life

Abstract Background FPCD remains a challenging condition with negative impact on quality of life. Recently, a novel classification was proposed intending to optimize and standardize the management of these patients (Geldof J, et al. Lancet Gastroenterol Hepatol. 2022 Jun;7(6):576-584). We aimed to characterize and classify a population of patients with FPCD according to this recent classification, evaluate the agreement between patient and clinician perspectives regarding disease treatment goals and correlate the new classification with patient’s quality of life. Methods Cross-sectional study which consecutively included FPCD’ adult patients (diagnosis > 6 months) followed at a gastroenterology consultation, from September to November 11, 2022. A Portuguese translated diagram of the new classification was presented to included patients, which had to select the class that most faithfully represents the current moment of their disease status. Subsequently, the IBDQ-32 questionnaire was completed. A separate form completed by a senior gastroenterologist include all the demographic and clinical data of each patient and the respective blindly chosen class. Results 23 patients (mean age of 34.4 ± 13.8 years, 60.7% woman) with FPCD were included. Disease location (Montreal Classification) was L1 in 9/23 patients, L2 in 5/23 patients and L3 in 9/23 patients. Two patients had also upper gastrointestinal tract involvement (L4). Crohn’s disease duration was 8.87 ± 8.176 years and fistula duration 4.26 ± 3.063 years (table 1). Therapy data including surgery is shown in Table 2. Most patients had a transphincteric (13/23) and complex fistula (20/23). Mean PDAI was 6±2.6 and HBI 2.2±1.65. Class 2a (repair) was the most frequently chosen by patients and clinician (62.5% and 58.3% respectively) (table 3). Mean IBDQ32 score was 97.6 ± 16.9 (table 4). A slight agreement between patient and clinician regarding the new classification system was found (Cohen’s Kappa of 0.176), and a negative correlation between the class chosen by the patient and the respective IBDQ-32 score (Kendalls’ Tau correlation coefficient -0.359, p = 0.033 (p<0,05)). Conclusion The low level of concordance between patient and clinician (with the limitation of a small sample size) draws attention to a gap in the treatment decision-making process of FPCD patients. A turning point in the management of these patients may occur with a progressive implementation of this classification into clinical practice after its validation, as it may allow for a shared discussion and greater patient responsibility in therapeutic decisions. The significant disease burden carried by these patients is underscored by the progressive lower IBDQ32 scores associated with higher class in this new system classification.

Achieving NKF-K/DOQI™ bone metabolism and disease treatment goals with cinacalcet HCl

The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF-K/DOQItrade mark) has established guidelines for treatment of secondary hyperparathyroidism (HPT). The ability of cinacalcet HCl (Sensipartrade mark) treatment to improve achievement of target levels of parathyroid hormone (PTH), calcium, phosphorus, and calcium-phosphorus product (Ca x P) was investigated in subjects on dialysis with secondary HPT. Data were combined from three placebo-controlled, double-blind, 26-week studies with similar design that randomized 1136 subjects on dialysis to receive traditional therapy plus cinacalcet or placebo. Oral cinacalcet was titrated from 30 to 180 mg/day. Achievement of K/DOQI goals was determined for each treatment group overall and for subgroups defined by baseline intact PTH (iPTH) and Ca x P levels. Cinacalcet-treated subjects were more likely to achieve a mean iPTH </=300 pg/mL (31.8 pmol/L) than were control subjects on traditional therapy (56% vs. 10%, P < 0.001). Cinacalcet-treated subjects were more likely to achieve concentrations of serum calcium within 8.4 to 9.5 mg/dL (2.10-2.37 mmol/L) and serum phosphorus within 3.5 to 5.5 mg/dL (1.13-1.78 mmol/L) than were control subjects (49% vs. 24% and 46% vs. 33%, P < 0.001 for each). Cinacalcet also improved achievement of Ca x P < 55 mg(2)/dL(2) (4.44 mmol(2)/L(2)) and concurrent achievement of Ca x P < 55 mg(2)/dL(2) (4.44 mmol(2)/L(2)) and iPTH </=300 pg/mL (31.8 pmol/L) (65% vs. 36% and 41% vs. 6%, P < 0.001 for each). In subjects on dialysis with secondary HPT, cinacalcet facilitates achievement of the K/DOQI-recommended targets for PTH, calcium, phosphorus, and Ca x P.