OBJECTIVES: Treatment of early rheumatoid arthritis (RA) include aiming at disease control with early use of methotrexate (MTX) in monotherapy or in combination with glucocorticoids or other disease-modifying drugs (DMARDs). The CIMESTRA study applied an aggressive treatment with DMARD and intra-articular injections of glucocorticoids (i.a. GC) to control disease activity. This paper reviews the results of the five years' study. METHODS:160 patients with early RA (<6 months duration) were randomized to receive MTX 7.5-20 mg/week+cyclosporine (CYA) 2.5-4 mg/kg (combination) or MTX+placebo-CYA (monotherapy). At each visit (week 0, 2, 4, 6, 8, thereafter monthly up to 24 months) patients had steroid injections in all swollen joints. During year 2, CYA/placebo was withdrawn, and hydroxychlorochine added. Clinical responses were assessed by ACR20, 50 and 70, ACR and DAS remission. Radiographic progression by x-rays of hands and feet. RESULTS: At year 1 (year 5) treatment responses in mono/combination groups were: ACR20: 68% (85%) / 85% (94%), ACR50: 53% (74%) / 68% (88%), ACR70: 44% (63%) / 59% (72%). After year 1, no significant differences between groups were found. Remission rates were: ACR-remission: 28% (52%) / 35% (60%), DAS28-remission: 34% (76%) / 43% (80%). Radiographic progression in both groups was <1TSS unit/year. After 1 and 2 years, 62% and 56% of the injected joints had not relapsed (both groups). Cumulated i.a.GC dose <1mg prednisolone/day. 19% received biologics by 5 years, 16% no treatment (sustained ACR-remission). Baseline magnetic resonance imaging (MRI) bone oedema best predicted radiographic progression after 2 years. Treatments were well tolerated. CONCLUSIONS:MTX and i.a.GC in a treat-to-target strategy over 5 years halted radiographic progression and induced remission in the majority of patients. I.a. GC had in long-lasting effect and cumulated dosages were low.
RCT Entities:
OBJECTIVES: Treatment of early rheumatoid arthritis (RA) include aiming at disease control with early use of methotrexate (MTX) in monotherapy or in combination with glucocorticoids or other disease-modifying drugs (DMARDs). The CIMESTRA study applied an aggressive treatment with DMARD and intra-articular injections of glucocorticoids (i.a. GC) to control disease activity. This paper reviews the results of the five years' study. METHODS: 160 patients with early RA (<6 months duration) were randomized to receive MTX 7.5-20 mg/week+cyclosporine (CYA) 2.5-4 mg/kg (combination) or MTX+placebo-CYA (monotherapy). At each visit (week 0, 2, 4, 6, 8, thereafter monthly up to 24 months) patients had steroid injections in all swollen joints. During year 2, CYA/placebo was withdrawn, and hydroxychlorochine added. Clinical responses were assessed by ACR20, 50 and 70, ACR and DAS remission. Radiographic progression by x-rays of hands and feet. RESULTS: At year 1 (year 5) treatment responses in mono/combination groups were: ACR20: 68% (85%) / 85% (94%), ACR50: 53% (74%) / 68% (88%), ACR70: 44% (63%) / 59% (72%). After year 1, no significant differences between groups were found. Remission rates were: ACR-remission: 28% (52%) / 35% (60%), DAS28-remission: 34% (76%) / 43% (80%). Radiographic progression in both groups was <1TSS unit/year. After 1 and 2 years, 62% and 56% of the injected joints had not relapsed (both groups). Cumulated i.a.GC dose <1mg prednisolone/day. 19% received biologics by 5 years, 16% no treatment (sustained ACR-remission). Baseline magnetic resonance imaging (MRI) bone oedema best predicted radiographic progression after 2 years. Treatments were well tolerated. CONCLUSIONS:MTX and i.a.GC in a treat-to-target strategy over 5 years halted radiographic progression and induced remission in the majority of patients. I.a. GC had in long-lasting effect and cumulated dosages were low.
Authors: C Fiehn; J Holle; C Iking-Konert; J Leipe; C Weseloh; M Frerix; R Alten; F Behrens; C Baerwald; J Braun; H Burkhardt; G Burmester; J Detert; M Gaubitz; A Gause; E Gromnica-Ihle; H Kellner; A Krause; J Kuipers; H-M Lorenz; U Müller-Ladner; M Nothacker; H Nüsslein; A Rubbert-Roth; M Schneider; H Schulze-Koops; S Seitz; H Sitter; C Specker; H-P Tony; S Wassenberg; J Wollenhaupt; K Krüger Journal: Z Rheumatol Date: 2018-08 Impact factor: 1.372
Authors: W U Kampen; B Boddenberg-Pätzold; M Fischer; M Gabriel; R Klett; M Konijnenberg; E Kresnik; H Lellouche; F Paycha; L Terslev; C Turkmen; F van der Zant; L Antunovic; E Panagiotidis; G Gnanasegaran; T Kuwert; T Van den Wyngaert Journal: Eur J Nucl Med Mol Imaging Date: 2021-10-20 Impact factor: 9.236
Authors: Annette de Thurah; Ina Trolle Andersen; Andreas Bugge Tinggaard; Anders Hammerich Riis; Josephine Therkildsen; Hans Erik Bøtker; Morthen Bøttcher; Ellen-Margrethe Hauge Journal: RMD Open Date: 2020-01