PMID- 18163521
OWN - NLM
STAT- MEDLINE
DCOM- 20080310
LR  - 20220331
IS  - 0004-3591 (Print)
IS  - 0004-3591 (Linking)
VI  - 58
IP  - 1
DP  - 2008 Jan
TI  - Comparison of the clinical efficacy and safety of subcutaneous versus oral 
      administration of methotrexate in patients with active rheumatoid arthritis: 
      results of a six-month, multicenter, randomized, double-blind, controlled, phase 
      IV trial.
PG  - 73-81
LID - 10.1002/art.23144 [doi]
AB  - OBJECTIVE: To compare the efficacy and safety of subcutaneous (SC) versus oral 
      administration of methotrexate (MTX) in patients with active rheumatoid arthritis 
      (RA). METHODS: MTX-naive patients with active RA (Disease Activity Score in 28 
      joints >or= 4) were eligible for the study if they had not previously taken 
      biologic agents and had not taken disease-modifying antirheumatic drugs for 2 
      weeks prior to randomization. Patients were randomly assigned to receive 15 
      mg/week of MTX either orally (2 7.5-mg tablets plus a dummy prefilled syringe; 
      n=187 patients) or SC (prefilled syringe containing 10 mg/ml plus 2 dummy 
      tablets; n=188 patients) for 24 weeks. At week 16, patients who did not meet the 
      American College of Rheumatology criteria for 20% improvement (ACR20) were 
      switched from 15 mg of oral MTX to 15 mg of SC MTX and from 15 mg of SC MTX to 20 
      mg of SC MTX for the remaining 8 weeks, still in a blinded manner. The primary 
      outcome was an ACR20 response at 24 weeks. RESULTS: At week 24, significantly 
      more patients treated with SC MTX than with oral MTX showed ACR20 (78% versus 
      70%) and ACR70 (41% versus 33%) responses. Patients with a disease duration >or= 
      12 months had even higher ACR20 response rates (89% for SC administration and 63% 
      for oral). In 52 of the ACR20 nonresponders (14%), treatment was switched at week 
      16. Changing from oral to SC MTX and from 15 mg to 20 mg of SC MTX resulted in 
      30% and 23% ACR20 response rates, respectively, in these patients. MTX was well 
      tolerated. The rate of adverse events was similar in all groups. CONCLUSION: This 
      6-month prospective, randomized, controlled trial is the first to examine oral 
      versus SC administration of MTX. We found that SC administration was 
      significantly more effective than oral administration of the same MTX dosage. 
      There was no difference in tolerability.
FAU - Braun, J
AU  - Braun J
AD  - Rheumazentrum Ruhrgebiet, Herne, Germany. J.Braun@rheumazentrum-ruhrgebiet.de
FAU - Kastner, P
AU  - Kastner P
FAU - Flaxenberg, P
AU  - Flaxenberg P
FAU - Wahrisch, J
AU  - Wahrisch J
FAU - Hanke, P
AU  - Hanke P
FAU - Demary, W
AU  - Demary W
FAU - von Hinuber, U
AU  - von Hinuber U
FAU - Rockwitz, K
AU  - Rockwitz K
FAU - Heitz, W
AU  - Heitz W
FAU - Pichlmeier, U
AU  - Pichlmeier U
FAU - Guimbal-Schmolck, C
AU  - Guimbal-Schmolck C
FAU - Brandt, A
AU  - Brandt A
CN  - MC-MTX.6/RH Study Group
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arthritis Rheum
JT  - Arthritis and rheumatism
JID - 0370605
RN  - 0 (Antirheumatic Agents)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
CIN - Nat Clin Pract Rheumatol. 2008 Jul;4(7):342-3. PMID: 18521111
CIN - Arthritis Rheum. 2008 Jul;58(7):2209; author reply 2209-10. PMID: 18576338
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Antirheumatic Agents/*administration & dosage/*adverse effects
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Male
MH  - Methotrexate/*administration & dosage/*adverse effects
MH  - Middle Aged
MH  - Treatment Outcome
EDAT- 2008/01/01 09:00
MHDA- 2008/03/11 09:00
CRDT- 2008/01/01 09:00
PHST- 2008/01/01 09:00 [pubmed]
PHST- 2008/03/11 09:00 [medline]
PHST- 2008/01/01 09:00 [entrez]
AID - 10.1002/art.23144 [doi]
PST - ppublish
SO  - Arthritis Rheum. 2008 Jan;58(1):73-81. doi: 10.1002/art.23144.