Efficacy and tolerability of leflunomide in difficult-to-treat polymyalgia rheumatica and giant cell arteritis: a case series T. Adizie, 1 D. Christidis, 2 C. Dharmapaliah, 3 F. Borg, 4 B. Dasgupta 5 Introduction Polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) are related inflammatory rheumatic conditions affecting adults over the age of 50 years. Both condi- tions respond to initial glucocorticoid (GC) therapy. However, most patients require 12–36 months of a tapering steroid regime. The requirement for initially high dose (in GCA) and long term therapy (in both) is associated with a high GC toxicity burden. Adverse events at 2 years are seen in up to 65% of patients with PMR (1) and 86% of patients with GCA (2) with over 50% developing serious events (3). The most sig- nificant are fractures (38%), infections (31%), hyper- tension (22%) and diabetes mellitus (9%). The earliest side effects are hypertension, mood changes and dia- betes mellitus while fractures and cataracts tending to occur at later times (i.e. beyond 12 months) (4). These complications of GC therapy cause important morbid- ity and increased health care costs. The life expectancy of patients with PMR and GCA and the general population have been reported to be similar, but the incidence of cardiovascular dis- ease is considerably higher than in the general popu- lation and may be attributed to inadequate treatment of disease or the toxicity of corticosteroid treatment (4–6). Late morbidity in GCA is also seen principally because of stroke, aortic aneurysm or dissection (6). There is a high incidence of relapse in both diseases, 40% within 2 years for GCA (2) and 50% of patients with PMR at some point having a relapse (3). Effective steroid-sparing adjuvant therapies, for the above reasons, are urgently required especially in incomplete, poorly sustained or non-responders to GC. Apart from Methotrexate, no other Disease- modifying antirheumatic drugs (DMARDs) or biologic agent has proven consistently effective in inducing or maintaining remission in PMR or GCA (2). Current practice in PMR and GCA An initial dose of 15 mg of prednisolone per day is adequate in most cases of PMR (3). Glucocorticoids should co-precribed with bone and (if needed) gastro-protective medications and gradually tapered to avoid a flare. High dose GC should be started immediately in suspected GCA and not delayed awaiting temporal artery biopsy. Current guidelines suggest that the initial dose of prednisolone should be 1 mg ⁄ kg body weight (not exceeding 60 mg ⁄ day) maintained for 4 weeks and tapered gradually there- after (2). If ischaemic symptoms or complications, 1 Rheumatology Research Fellow, Southend University Hospital 2 Rheumatology Research Fellow, Southend University Hospital 3 Specialist Rheumatology Registrar, Southend University Hospital 4 Consultant Rheumatologist, Southend University Hospital 5 Consultant Rheumatologist & Honorary Professor, Essex University, Southend University Hospital, Westcliff-on-sea, United Kingdom Correspondence to: B. Dasgupta, Consultant Rheumatologist & Honorary Professor, Essex University, Southend University Hospital Tel.: 0441702385252 Fax: 00441702385909 Email: bhaskar.dasgupta@ southend.nhs.uk Disclosure Professor Dasgupta has received Honoraria from Merck, Roche and Mundipharma. SUMMARY Polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) are related inflammatory rheumatic conditions affecting adults over the age of 50 years. Both conditions respond to initial glucocorticoid (GC) therapy. However, most patients require 12–36 months of a tapering steroid regime. Adverse events at 2 years are seen in up to 65% of patients with PMR and 86% of patients with GCA with over 50% developing serious events. There is also a high incidence of relapse in both diseases )40% within 2 years for GCA and 50% of patients with PMR at some point having a relapse. Effective steroid-sparing adjuvant therapies are urgently required especially in incomplete, poorly sustained or non-responders to glucocorticoids. In this case ser- ies, we found that Leflunomide is efficacious, with 22 out of our 23 patients exhibit- ing a complete or partial response. It was also steroid sparing and well tolerated. It may be a useful adjunctive agent in difficult-to-treat GCA and PMR. Prospective randomised controlled trials of Leflunomide in both GCA and PMR are now required. What’s known The toxicity and frequent disease flares in patients with PMR and GCA on long term corticosteroid therapy represents the need for better and safer disease control. Reported trials of conventional DMARDs and biologic agents have not shown great promise. What’s new This open case series reports the beneficial effects of Leflunomide which was well tolerated in 23 cases with steroid unresponsive difficult to treat PMR and GCA. We suggest that randomised controlled trials of Leflunomide be developed for PMR and GCA. SHORT REPORT ª 2012 Blackwell Publishing Ltd 906 Int J Clin Pract, September 2012, 66, 9, 906–909. doi: 10.1111/j.1742-1241.2012.02981.x