Woon Leung Ng

Tacrolimus versus mycophenolate mofetil for induction therapy of lupus nephritis: a randomised controlled trial and long-term follow-up

Objective To compare the efficacy of tacrolimus (TAC) and mycophenolate mofetil (MMF) for the initial therapy of lupus nephritis (LN). Study design This is an open randomised controlled parallel group study. Methods Adult patients with biopsy-confirmed active LN (class III/IV/V) were randomised to receive prednisolone (0.6 mg/kg/day for 6 weeks and tapered) in combination with either TAC (0.06–0.1 mg/kg/day) or MMF (2–3 g/day) for 6 months. Good responders were shifted to azathioprine for maintenance. The primary outcome was the rate of complete renal response (CR) at 6 months and the secondary outcomes included partial renal response, renal flares and decline of renal function over time. Results 150 patients (92% women; aged 35.5±12.8 years; 81% class III/IV) were randomised (76 MMF, 74 TAC). At month 6, the rate of CR was 59% in the MMF and 62% in the TAC group (treatment difference: 3.0% (−12%, 18%); p=0.71). Major infective episodes occurred in 9.2% patients treated with MMF and in 5.4% patients treated with TAC (p=0.53). Maintenance therapy with azathioprine was given to 79% patients. After 60.8±26 months, proteinuric and nephritic renal flares developed in 24% and 18% of patients in the MMF group and 35% (p=0.12) and 27% (p=0.21) in the TAC group, respectively. The cumulative incidence of a composite outcome of decline of creatinine clearance by ≥30%, development of chronic kidney disease stage 4/5 or death was 21% in the MMF and 22% in the TAC group of patients (p=0.35). Conclusions TAC is non-inferior to MMF, when combined with prednisolone, for induction therapy of active LN. With azathioprine maintenance for 5 years, a non-significant trend of higher incidence of renal flares and renal function decline is observed with the TAC regimen. Trial registration number Hospital Authority Research Ethics Committee Clinical Trial Registry (HARECCTR0500018; Hong Kong) and US ClinicalTrials.gov (NCT00371319).

THU0581-HPR Effectiveness of A Rheumatology Nurse Follow up Programme in Achieving the Desired Target Serum Urate Levels for Patients with Gouty Arthritis

Background Urate lowering therapy (ULT) can effectively reduce serum urate level (SUA) and flares for gout, thereby minimizing progressive joint damage. Despite advances in therapies for gout and the publication of international guidelines, studies repeatedly showed that many patients remained undertreated worldwide. To help achieving treatment targets for gout, a rheumatology nurse follow-up programme (RNFP) was set up to provide patients with comprehensive education and telephone follow-up to monitor the disease control, treatment adherence and occurrence of adverse drug effects. Appropriate and timely intervention and counseling would be given to patients who were found to have adverse drug effects or treatment non-concordance. Objectives The objectives of this study were to evaluate the effectiveness of RNFP in achieving the desired SUA for patients taking ULT and its role in detecting adverse drug effects and treatment concordance problems. Methods This was a retrospective, observational study in a regional hospital in Hong Kong serving predominantly Southern Chinese. Patients with gouty arthritis with or without tophi requiring initiation or titration of ULT (allopurinol, probenecid or febuxostat) were recruited into the RNFP by rheumatologists. Patient profiles, SUA at the time of recruitment and end of study, incidents of adverse drug effects and drug non-concordance were recorded. The primary outcome was the achievement of target SUA of <0.3 mmol/L and <0.36 mmol/L for gouty arthritis patients with and without tophi respectively at study end. Results From May 2011 to December 2013, 89 patients were recruited into the programme. Fifty three were male. Mean age was 66 years (33-93 years). Eighteen patients had tophi. Duration of nurse follow-up for each patient was 18.7 weeks (1.4 – 120.1weeks). Number of patients using allopurinol, febuxostat and probenecid were 81, 13 and 11 respectively. The mean pre-recruitment SUA was 0.529 mmol/L (0.330 to 0.945 mmol/L, standard deviation 0.112 mmol/L). Only 4.5% of gouty arthritis patients and none of the tophaceous gout patients had SUA within the defined therapeutic targets at the time of recruitment. At study end, mean SUA was significantly reduced to 0.364 mmol/L (-0.165 mmol/L; 95% confidence interval -0.124 to -0.190; P<0.00001). The percentage of patients achieving pre-defined target SUA were 38.9% and 53.7% for patients with and without tophi respectively. During the study period, 25 episodes of adverse incidents were detected. Majority (68%) was related to skin rash and pruritus. Thirty-one patients (34.8%) were identified to have drug concordance problems including self-adjustment of dosage and self-stopping of drug treatment. Conclusions Adverse drug effects and drug non-concordance were common in gouty arthritis patients receiving urate lowering therapy. A dedicated rheumatology nurse follow-up programme allows timely detection and intervention of treatment related problems to enhance the achievement of recommended target urate levels. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.2838

THU0587-HPR Nurse-Led Biologic Infusion – A Safe Service That Saves

Background In the conventional practice of biologic infusion in Hong Kong, patients have to be seen by rheumatologist for every visit to get the prescription followed by drug purchase and administration. To streamline the workflow and to reduce doctors workload on routine visits, a pilot project of nurse-led biologic infusion (NLBI) clinic has been launched. Objectives (1) To evaluate the effectiveness and safety of the NLBI service; (2) to assess the reduction in patient waiting time from admission to discharge in day ward and (3) to quantify the reduction in workload of rheumatologists. Methods Patients receiving biologic therapy with stable conditions were recruited to the NLBI clinic by rheumatologists. Alternating follow-up sessions by NLBI clinic and rheumatologist was arranged. Rheumatologists would assess the patient and prescribe the appropriate drug regime for the next NLBI clinic. During NLBI clinic visit, patients clinical conditions, including their disease activity, laboratory results and vital signs were assessed according to standardized protocol to ensure treatment safety. After the infusion therapy, rheumatology nurse will make proper discharge record to ensure continuity of care. For patients with unstable conditions or infusion reactions, rheumatologists are readily available for timely management. Results The NLBI clinic was set up in April 2012, totally 23 patients were recruited in the clinic and currently 21 patients (91.3% of total biologic infusion case) were still under the programme. Two patients dropped out due to switching to other biologics which are administrated by subcutaneous injection. Three episodes required ad hoc referral to rheumatologist for medical problems including hyperglycaemia, hypertension and skin rash. From April 2012 to December 2013, the total NLBI clinic attendances were 90. All cases were given biologic infusion safely and successfully without any adverse effects. Patients saved 45minutes in each visit since there is no need to wait for drug prescription and collection. The alternating follow-up arrangement also reduced doctors workload by 50%. A questionnaire survey was administered to all recruited patients with 20 questionnaires collected (response rate 95.3%). 18 out of 20 (90%) patients either agreed or strongly agreed that adequate pre-treatment assessment was provided. Majority (19/20, 95%) of the patients reported that they have saved time in each attendance and 70% of them saved more than 30 minutes and 35% of them saved more than 1 hour. All participating patients (20/20, 100%) either agreed or strongly agreed that the overall Nurse-led Biologic Infusion Service was satisfactory. All of the patients agreed or strongly agreed that they would like to continue the service from rheumatology nurse. Conclusions Nurse-led biologic infusion is smooth and safe. It saves patients time in terms of the total duration of the treatment session. Furthermore, it spares the time of rheumatologists spent on routine visits and enables them to concentrate on the management of more complex cases. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.2925