Predictors of drug retention and treatment response in axial spondyloarthritis patients treated with certolizumab: real-life results from the HURBIO registry.

OBJECTIVES: To assess the real-life retention rate of certolizumab and factors related to retention of certolizumab. METHODS: We analysed all patients who received at least 1 dose of certolizumab and were registered in the HURBIO database. Patients with at least 1 control visit were included in efficacy analysis. Drug retention rates were calculated using the Kaplan-Meier method and predictors of drug retention was determined by Cox proportional hazard model. Factors predicting BASDAI50 response at first visit were analysed by the logistic regression analysis. Reasons of switching and discontinuation were also determined. RESULTS: A total of 325 (AS (76%), female 55%) patients were recruited. Median follow-up while receiving certolizumab was 13 (4.7-22.7) months. At 1 year, overall certolizumab retention rate was 72.5%. Predictors of poor certolizumab retention were: Current or ex-smoker [HR 1.11 (0.70-1.76), p=0.65], high CRP levels [HR 0.72 (0.45-1.16), p=0.18], biologic-naïve [HR 0.81 (0.49-1.32), p=0.39] and good BASDAI50 response at first control visit [HR 0.54 (0.30-0.96), p=0.04]. Mean duration from starting certolizumab to the first control visit was 3 (3-6) months. Predictors of poor BASDAI50 response: Presence of nr-axSpa [RR 2.12 (1.01-4.51), p=0.05], female gender [RR 2.14 (1.20-3.82), p=0.01] and history of biologic therapy [RR 3.52 (1.95-6.33), p<0.001]. The most common causes of drug switch were primary failure and drug side-effects. CONCLUSIONS: In this study, good BASDAI50 response at first visit seems to be a strong predictor of higher retention of certolizumab in patients with axial spondyloarthritis.

Avascular necrosis less frequently found in systemic lupus erythematosus patients with the use of alternate day corticosteroid

Background/aim: Avascular necrosis (AVN) is the death of bone due to compromise of blood flow. The etiology of AVN is multifactorial; corticosteroid usage is the second most significant factor after trauma, and systemic lupus erythematosus (SLE) is the most common underlying disease. The objective of this study was to assess the factors of AVN in SLE patients. Materials and methods: The study included 127 patients with SLE who fulfilled 1997 American College of Rheumatology (ACR) revised criteria. Demographic data, age at SLE diagnosis, disease duration, disease activity, body mass index, clinical findings, antiphospholipid syndrome, steroid usage, dose and duration, comorbid diseases, and smoking history were recorded. Results: AVN was found in 11 of 127 (8.7%) SLE patients. Hyperlipidemia (P < 0.001), cushingoid body habitus (P < 0.001), and proteinuria (P = 0.013) were found at higher rates in the AVN group. All of the 11 AVN cases had osteoporosis (P < 0.02). In multivariate regression analysis, daily steroid usage was the only factor for development of AVN in SLE. Conclusion: The hypothesis of our study was that an alternate day steroid regimen may decrease AVN frequency in SLE patients.

Factors that predict development of chronic kidney disease in patients with rheumatoid arthritis receiving biologic DMARDs and mortality rates.

OBJECTIVES: We aimed to determine the choice of biologic/targeted synthetic disease-modifying anti-rheumatic drugs (b/ts-DMARDs), factors associated with the development of chronic kidney disease (CKD), and mortality in RA patients with CKD receiving b/ts-DMARDs. METHODS: Two thousand one hundred forty-one RA (79.4% female) patients were included in the analysis from the HUR-BIO prospective registry. Patients were divided into the CKD group and the non-CKD group. Age and gender-matched patients were selected from the non-CKD group, and then three main groups were determined. CKD was staged according to the glomerular filtration rate criteria. The clinical characteristics of the patients, disease activities, treatment choices, drug retention rate, and mortality rates were compared between the groups. RESULTS: CKD was detected in 90/2141 (4.2%) RA patients on b/ts-DMARDs. Forty patients (2.3%) developed CKD during follow-up after the initiation of b/ts-DMARDs. In the CKD group, anti-TNF agents were chosen as the first-line b/ts-DMARDs therapy in 64.4% of patients, with etanercept leading in 31 (34.4%) patients. In multivariate analysis, age at the start of treatment, DAS-28-ESR at last visit, amyloidosis, hypertension, and history of smoking were the factors associated with the development of CKD in RA patients receiving b/ts-DMARDs. The mortality rate in RA-CKD patients until the onset of the pandemic was 15.41 per 1000 patient years, whereas it was 85.9 per 1000 patient years after the pandemic. CONCLUSION: Comorbidities and control of disease activity are critical in the development of CKD in RA patients receiving b/ts-DMARDs. While there was no significant difference in mortality rate between CKD and non-CKD patients, the overall mortality rate increased after the COVID-19 pandemic duration in both groups.

Prophylactic use of lamivudine with chronic immunosuppressive therapy for rheumatologic disorders.

The objective of this study was to report our experience concerning the effectiveness of the prophylactic administration of lamivudine in hepatitis B virus surface antigen (HBs Ag) positive patients with rheumatologic disease. From June 2004 to October 2006, 11 HBs Ag positive patients with rheumatologic diseases, who were on both immunosuppressive and prophylactic lamivudine therapies, were retrospectively assessed. Liver function tests, hepatitis B virus (HBV) serologic markers, and HBV DNA levels of the patients during follow-up were obtained from hospital file records. Eleven patients (six male) with median age 47 years (range 27-73), median disease duration 50 months (range 9-178) and median follow-up period of patients 13.8 months (range 5-27) were enrolled in this study. Lamivudine therapy was started 3-7 days prior to immunosuppressive therapy in all patients. Baseline, liver function tests were elevated in two patients (fourth patient: ALT:122 IU/l, AST:111 IU/l, tenth patient:ALT:294 IU/l, AST:274 IU/l, with minimal changes in the liver biopsy in both). Shortly after treatment their tests normalized and during follow-up period none of the patients had abnormal liver function tests. In four patients HBV DNA levels were higher than normal at baseline. Two of these normalized and the others increased later. In three additional patients, HBV DNA levels were increased during follow-up. None of the patients had significant clinical sings of HBV activation. Lamivudine was well tolerated and was continued in all patients. Prophylactic administration of lamivudine in patients who required immunosuppressive therapy seems to be safe, well tolerated and effective in preventing HBV reactivation.

Increased serum vitamin B12 levels are associated with adult-onset Still's disease with reactive macrophage activation syndrome.

BACKGROUND: Adult-onset Still's disease (AOSD) can be complicated by reactive macrophage activation syndrome (rMAS). The objective of this study was to evaluate vitamin B(12) values in AOSD with and without rMAS. METHODS: All patients' files with AOSD in one center were retrospectively reviewed. Hemophagocytosis was defined as phagocytosis of various hematopoietic cells by macrophages. Clinical data including fever, rash, sore throat, arthritis, lymphadenopathy were recorded. Laboratory tests included complete blood count, serum ferritin, transaminases, serum triglyceride and vitamin B(12) level. The control group was selected from our AOSD pool who had AOSD without rMAS. RESULTS: Seven patients (5 female) had AOSD with rMAS. Median age at the diagnosis of rMAS was 32 (range, 27-37) and median follow-up duration after rMAS diagnosis was 18 months (range, 2-60). All of the patients with rMAS had fever, sore throat, rash, arthritis, anemia and hyperferritenemia. Five of seven patients had hepatosplenomegaly and lymphadenopathy. Four of seven patients had normal or low leucocyte count, three of seven patients had increased triglyceride level. The patients with AOSD and rMAS mean+/-standard deviation (S.D.) vitamin B(12) levels were significantly higher than without rMAS (1903+/-960 vs 542+/-328pg/ml, p=0.001). The specificity (75%) of increased vitamin B(12) level was high and sensitivity (100%) was excellent. CONCLUSION: Elevated vitamin B(12) levels seems to be a good marker for diagnostic marker in AOSD when complicated with rMAS.