An audit of the use of hydroxychloroquine in rheumatology clinics

Objectives To audit the use, indications, complications and patient information regarding hydroxychloroquine (HCQ) treatment in rheumatology clinics in a tertiary referral centre. Methods During a 9-month period, we identified all patients prescribed HCQ and attending rheumatology clinics in one hospital. We established: (1) the indication for HCQ (2) the prevalence of HCQ overdosing based on absolute body weight (ABW) (3) documentation of warning of risk of retinal toxicity (4) systemic and ocular co-morbidities (5) ocular symptoms during treatment (6) reasons for stopping HCQ. Results We identified 427 patients (104 male, 323 female). The cumulative dose of HCQ was lower in rheumatoid arthritis (RA; median 365 g; range 6-1752 g) compared to systemic lupus erythematosus (SLE; 450 g; 66-1788 g) (p = 0.105). The median duration of HCQ therapy was four years (range 0.1-13); 28% of patients with RA and 29% with SLE continued HCQ beyond five years. After adjusting for ABW and renal function, 10% (31/312) had been prescribed doses exceeding recommendations. Formal documentation of counselling on ocular complications was only found in one third of patients. Three cases of HCQ retinopathy were identified (all of whom had RA). Conclusion HCQ therapy is being used for more than five years in 29% of patients with rheumatic diseases, with higher than recommended doses in approximately 10% of patients. We recommend more rigorous scrutiny of the use of HCQ to reduce the risk of retinopathy

Long-term efficacy and tolerability of TNFα inhibitors in the treatment of non-infectious ocular inflammation:an 8-year prospective surveillance study

BACKGROUND/AIM: To report the efficacy and tolerability of antitumour necrosis factor-alpha therapy (TNF inhibitors [TNFi]) in the management of non-infectious ocular inflammation, including uveitis and scleritis, in adult patients over an 8-year period. MATERIALS AND METHODS: This is a prospective cohort study of infliximab and adalimumab in the treatment of non-infectious ocular inflammatory disease. 43 of 85 adult patients on TNFi (34 infliximab, 9 adalimumab) for ≥1 year with non-infectious uveitis or scleritis were followed from 2006 to 2014. Clinical assessments, medication, adverse events and history of steroid rescues were collected at 6 monthly intervals. General quality of life (Short Form Health Survey (SF-36)) and visual quality of life (Vision-related quality of life Core Measure (VCM1)) were assessed annually. Outcome measures included rate of sustained remission, rate of relapse, systemic corticosteroid reduction, adverse events, and VCM1 and SF-36 scores. RESULTS: The median time on infliximab was 3.2 years (IQR 4.3) and on adalimumab was 2.4 years (IQR 1.8). Sustained remission was induced in 39 patients (91%) (0.5 per patient year) after a median of 1.2 years on a TNFi. 22 (51%) experienced one relapse, and 5 (12%) had two relapses. 23 (54%) had at least one adverse event; serious adverse events necessitating hospitalisation or cessation of medication occurred in four (9%) patients. 10 patients (23%) switched from the initiation of TNFi, at 1.7 years after starting, to another TNFi or another class of biologic therapy. CONCLUSION: TNFi treatment is associated with long-term drug-induced remission of ocular inflammation, visual stability and corticosteroid reduction. Adverse events were common and no new safety signals occurred. Relapse of inflammation occurs in half of the treated population

Adalimumab vs placebo as add-on to Standard Therapy for autoimmune Uveitis: Tolerability, Effectiveness and cost-effectiveness-a protocol for a randomised controlled trial (ASTUTE trial).

IntroductionAdalimumab is an effective treatment for autoimmune non-infectious uveitis (ANIU), but it is currently only funded for a minority of patients with ANIU in the UK as it is restricted by the National Institute for Health and Care Excellence guidance. Ophthalmologists believe that adalimumab may be effective in a wider range of patients. The Adalimumab vs placebo as add-on to Standard Therapy for autoimmune Uveitis: Tolerability, Effectiveness and cost-effectiveness (ASTUTE) trial will recruit patients with ANIU who do and do not meet funding criteria and will evaluate the effectiveness and cost-effectiveness of adalimumab versus placebo as an add-on therapy to standard care.Methods and analysisThe ASTUTE trial is a multicentre, parallel-group, placebo-controlled, pragmatic randomised controlled trial with a 16-week treatment run-in (TRI). At the end of the TRI, only responders will be randomised (1:1) to 40 mg adalimumab or placebo (both are the study investigational medicinal product) self-administered fortnightly by subcutaneous injection. The target sample size is 174 randomised participants. The primary outcome is time to treatment failure (TF), a composite of signs indicative of active ANIU. Secondary outcomes include individual TF components, retinal morphology, adverse events, health-related quality of life, patient-reported side effects and visual function, best-corrected visual acuity, employment status and resource use. In the event of TF, open-label drug treatment will be restarted as per TRI for 16 weeks, and if a participant responds again, allocation will be switched without unmasking and treatment with investigational medicinal product restarted.Ethics and disseminationThe trial received Research Ethics Committee (REC) approval from South Central - Oxford B REC in June 2020. The findings will be presented at international meetings, by peer-reviewed publications and through patient organisations and newsletters to patients, where available.Trial registrationISRCTN31474800. Registered 14 April 2020

A Review of the Landscape of Targeted Immunomodulatory Therapies for Non-Infectious Uveitis

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