PMID- 21298986
OWN - NLM
STAT- MEDLINE
DCOM- 20110315
LR  - 20191210
IS  - 1426-9686 (Print)
IS  - 1426-9686 (Linking)
VI  - 29
IP  - 174
DP  - 2010 Dec
TI  - [Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor 
      therapy in Poland].
PG  - 365-8
AB  - Results of a multicenter, non-interventional, observational study assessing 
      efficacy and safety of 1st course rituximab treatment with methotrexate in 
      patients with rheumatoid arthritis and a history of inadequate response to 
      anti-TNF-therapies, in the routine clinical settings in Poland (MIRACLE-POL 1). 
      The aim of the study was to determine the efficacy and safety of treatment with 
      rituximab and methotrexate in patients with active rheumatoid arthritis (RA) who 
      had inadequate response to anti-TNF-therapies in routine clinical settings in 
      Poland. MATERIAL AND METHODS: We evaluated effectiveness and safety of RTX and 
      MTX therapy in 73 patients enrolled in the multicenter, non-interventional, 
      observational study. Patients with active RA had a history of an inadequate 
      response to 1 or more anti-TNF-alpha agents received 1st course of rituximab 
      consisting of 2 intravenous infusions of 1000 mg each. The end points were: EULAR 
      response criteria at 180 days, changes of Disease Activity Scores in 28 joints 
      (DAS28) from the original baseline at 180 days, rate of remission, rate of low 
      disease activity according to EULAR criteria and rate of adverse events (AEs) 
      during treatment. RESULTS: At 180 days 22% of treated patients demonstrated 
      good-to-moderate EULAR response and 12% of patients demonstrated moderate 
      response. In 77% of cases DAS28 decreased > 1.2. 16% of patients achieved 
      remission according to EULAR criteria and 23% of patients achieved low disease 
      activity. After 180 days mean DAS28 score decreased from 6.33 to 4.06. In 16% of 
      patients AEs occurred with the first rituximab infusion, in 12% of patients with 
      the second rituximab one, and in 43% of patients afterwards. All AEs were mild or 
      moderate in severity. There were no serious AEs including serious infections. 
      Infusion-associated AEs occurred in a higher proportion during the first 
      infusion. CONCLUSIONS: Results of this multicenter, non-interventional, 
      observational study confirm efficacy and safety of 1st course rituximab treatment 
      with concomitant methotrexate in patients with rheumatoid arthritis who had 
      inadequate response to anti-TNF-therapies in the routine clinical settings in 
      Poland.
FAU - Samborski, Wlodzimierz
AU  - Samborski W
AD  - Department of Physiotherapy, Rheumatology and Rehabilitation, Medical University 
      of Poznan, Poland.
FAU - Buczek, Jaroslaw
AU  - Buczek J
FAU - Bednarek, Agata
AU  - Bednarek A
FAU - Lewandowicz, Jolanta
AU  - Lewandowicz J
FAU - Kucharz, Eugeniusz
AU  - Kucharz E
LA  - pol
PT  - Journal Article
TT  - Rytuksymab w leczeniu chorych na reumatoidalne zapalenie stawow po niepowodzeniu 
      terapii inhibitorami TNF-alpha.
PL  - Poland
TA  - Pol Merkur Lekarski
JT  - Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego
JID - 9705469
RN  - 0 (Antibodies, Monoclonal, Murine-Derived)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Tumor Necrosis Factor Inhibitors)
RN  - 4F4X42SYQ6 (Rituximab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Antibodies, Monoclonal, Murine-Derived/*therapeutic use
MH  - Antirheumatic Agents/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Methotrexate/therapeutic use
MH  - Middle Aged
MH  - Rituximab
MH  - Treatment Outcome
MH  - Tumor Necrosis Factor Inhibitors
EDAT- 2011/02/09 06:00
MHDA- 2011/03/16 06:00
CRDT- 2011/02/09 06:00
PHST- 2011/02/09 06:00 [entrez]
PHST- 2011/02/09 06:00 [pubmed]
PHST- 2011/03/16 06:00 [medline]
PST - ppublish
SO  - Pol Merkur Lekarski. 2010 Dec;29(174):365-8.