Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study

التفاصيل البيبلوغرافية
العنوان: Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study
المؤلفون: Emery, P, Burmester, GR, Naredo, E, Sinigaglia, L, Lagunes, I, Koenigsbauer, F, Conaghan, PG
المصدر: Annals of the Rheumatic Diseases
بيانات النشر: BMJ Publishing Group, 2020.
سنة النشر: 2020
مصطلحات موضوعية: musculoskeletal diseases, Adult, Male, Remission Induction, Adalimumab, Rheumatoid Arthritis, DMARDs (biologic), anti-TNF, Middle Aged, Symptom Flare Up, Arthritis, Rheumatoid, Double-Blind Method, Antirheumatic Agents, Humans, Female, skin and connective tissue diseases, disease activity, Aged
الوصف: Objective: To investigate the association between baseline disease activity and the occurrence of flares after adalimumab tapering or withdrawal in patients with rheumatoid arthritis (RA) in sustained remission. Methods: The PREDICTRA phase IV, randomised, double-blind (DB) study (ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels, and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Patients) enrolled patients with RA receiving adalimumab 40 mg every other week who were in sustained remission ≥6 months. After a 4-week, open-label lead-in (OL-LI) period, patients were randomised 5:1 to DB adalimumab taper (every 3 weeks) or withdrawal (placebo) for 36 weeks. The primary endpoint was the association between DB baseline hand and wrist MRI-detected inflammation with flare occurrence. Results: Of 146 patients treated during the OL-LI period, 122 were randomised to taper (n=102) or withdrawal (n=20) arms. Patients had a mean 12.9 years of active disease and had received adalimumab for a mean of 5.4 years (mean 2.2 years in sustained remission). Overall, 37 (36%) and 9 (45%) patients experienced a flare in the taper and withdrawal arms, respectively (time to flare, 18.0 and 13.3 weeks). None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering. Approximately half of the patients who flared regained clinical remission after 16 weeks of open-label rescue adalimumab. The safety profile was consistent with previous studies. Conclusions: Approximately one-third of patients who tapered adalimumab versus half who withdrew adalimumab experienced a flare within 36 weeks. Time to flare was numerically longer in the taper versus withdrawal arm. Baseline MRI inflammation was not associated with flare occurrence. Trial registration number: NCT02198651, EudraCT 2014-001114-26.
وصف الملف: application/pdf
اللغة: English
تدمد: 1468-2060
0003-4967
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=pmid_dedup__::7d02339b5e6b6ff0b9300c10c1d7c622Test
http://europepmc.org/articles/PMC7392484Test
حقوق: OPEN
رقم الانضمام: edsair.pmid.dedup....7d02339b5e6b6ff0b9300c10c1d7c622
قاعدة البيانات: OpenAIRE