Drug retention is particularly relevant to assess long-term treatments. This real-world study mainly aimed to describe 1-year retention rate (RR) of subcutaneously administered tocilizumab (TCZ-SC) in patients with moderate to severe active rheumatoid arthritis (RA). This non-interventional, prospective, multicenter study (NCT02608112) was conducted in patients with RA initiating TCZ-SC treatment, with an 18-month follow-up. RR was estimated at month 12 in the overall population and baseline subgroups (combination with a conventional synthetic disease-modifying antirheumatic drug (csDMARD) or not, age, body mass index, methotrexate dose), using the Kaplan–Meier method. Patient compliance to TCZ-SC was described using the 5-item Compliance Questionnaire for Rheumatology (CQR5). At inclusion 75% of the 285 analyzed patients were women, mean RA duration was 9 ± 9 years, previous RA treatments included biological agents (63%) and/or csDMARDs (94%), mean Disease Activity Score 28 joints-Erythrocyte Sedimentation Rate (DAS28-ESR) was 4.8 ± 1.2. TCZ-SC RR at month 12 was estimated to be 64% (95% CI 58%–69%) with no statistical differences between subgroups. Clinical results improved with TCZ-SC; the proportion of patients treated with combined glucocorticoids decreased from 49% to 22% at month 12. At each follow-up time, at least 80% of patients were high adherers to TCZ-SC (at least 80% of theoretical injections). Among the 286 patients with at least one TCZ-SC injection, 25 patients (9%) experienced serious adverse events related to TCZ-SC with no differences according to patient age. This real-world study corroborates the RR at month 12 previously shown in interventional studies on TCZ-SC. Our data suggest there are no differences according to patient's profile (age, BMI), methotrexate doses, and TCZ-SC use. NCT02608112.
We have little real-world data in France on the natural history and management of patients with GCA.
Objectives
The objective of this observational study, named ARTEMIS, was to describe the characteristics and management of patients with GCA in real-life settings in France.
Methods
This was a cross-sectional, non-interventional, multicentre, single-visit survey, conducted among hospital-based physicians specialized in internal medicine or rheumatology. Investigators enrolled consecutive patients ≥ 50 years old seen for GCA and currently under treatment. Information on medical practices, such as patient characteristics and diagnostic journey, diagnostic methods and specific GCA treatments, were collected on an eCRF. GCA activity was assessed on a 100-mm VAS completed by the patients (PtGA) and physicians (PGA). GCA was considered active for VAS scores ≥10 mm. Newly diagnosed GCA was defined as diagnosis (Dg)-to-visit interval <6 weeks. Onset of symptoms-to-Dg interval was classified as "short" (<1 month), "intermediate" (1–3 months) and "long" (>3 months). Descriptive statistics were used for quantitative and qualitative variables.
Results
Over the 3-month inclusion period (August–November 2018), 306 patients were recruited (females: 67.3%, age at Dg ≥70 years: 72.5%); 260 (85.0%) and 46 (15.0%) were followed by internists or rheumatologists, respectively. Overall, 39 (12.7%) had newly diagnosed GCA, 267 (87.3%) had a GCA duration ≥ 6 weeks (mean follow-up 24.0±27.0 months). Original referral of patients to specialized centres was from GPs (55.9%), ophthalmologists (10.1%), neurologists (6.9%), emergency physicians (5.6%), internists (4.2%) and rheumatologists (4.9%). Mean time to Dg was 3.3±6.9 months, with an "intermediate" Dg interval for 57.5% of patients. The most common prior medical histories were hypertension (45.8%), psychiatric disorders (10.1%), dyslipidemia (11.8%), diabetes (9.5%) and osteoporosis (5.9%); during follow-up psychiatric disorders, diabetes and osteoporosis were more often reported: 12.1%, 14.7% and 8.5% of patients respectively. Initial GCA presentations included cranial symptoms (89.5% of patients), constitutional symptoms (73.9%), polymyalgia rheumatica (48.4%), and other extra-cranial manifestations (34.0%). Initial mean ESR and CRP level were 73.0±30.7 mm/hr and 87.3±68.3 mg/l. Temporal artery biopsy, high-resolution temporal artery Doppler ultrasonography, 18FDG-PET and aortic angio-CT were performed for 84.7%, 31.2%, 26.4% and 29.7% of patients, respectively, and contributed to GCA Dg for 67.1%, 52.7%, 70.3% and 36.8%. At study visit, PtGA was 28.1±26.4 and PGA was 13.1±21.4. Ongoing medications included glucocorticoids (GC) for 273 (89.2%) patients (mean dose: 14.9±16.7 mg/d), methotrexate for 35 (11.4%) and tocilizumab for 44 (14.4%). In total, 122 (39.9%) patients had ≥1 relapse (mean number of relapses: 1.7±1.0) after a mean time to a first relapse of 13.3±12.8 months. Total cumulative oral GC dose was 5179±4987 mg. GCA-related complications occurred in 48 (15.7%) pts with eye disorders in 15 (5.2%).
Conclusion
This observational, cross-sectional study of a large number of patients provides insight into current medical practices for GCA in France. Despite extensive use of large-vessel imaging, the proportion of patients diagnosed with non-cranial GCA is small (10%). The substantial proportion of patients with relapsing disease results in high cumulative doses of glucocorticoids. The number of patients with tocilizumab treatment was slightly greater than that with methotrexate treatment.
Disclosure of Interests
Alfred Mahr Consultant for: Chugai Pharma France, Speakers bureau: Roche SAS Chugai Pharma France, Marc Paccalin Consultant for: Chugai, Eric Hachulla Consultant for: Received consulting fees or other remuneration from Actelion, GSK, Pfizer, and Bayer, Isabelle Idier Employee of: ChugaiPharma france, Valerie Devauchelle-Pensec Grant/research support from: Roche-Chugai, Speakers bureau: MSD, BMS, UCB, Roche
