PMID- 26155618
OWN - NLM
STAT- MEDLINE
DCOM- 20150811
LR  - 20181023
IS  - 0040-3660 (Print)
IS  - 0040-3660 (Linking)
VI  - 87
IP  - 5
DP  - 2015
TI  - [Efficacy and safety of intravenous methylprednisolone in the treatment of 
      patients with active ankylosing spondylitis: results of a 12-week, prospective, 
      open-label, pilot (METALL) study].
PG  - 47-52
LID - 10.17116/terarkh201587547-52 [doi]
AB  - AIM: To evaluate the efficacy and safety of intravenous methylprednisolone (MP) 
      500 mg in patients with active ankylosing spondylitis (AS) and the inefficiency, 
      intolerability of or contraindications to treatment with 2 or more non-steroidal 
      anti-inflammatory drugs (NSAIDs). SUBJECTS AND METHODS: The investigation 
      enrolled 20 patients (age, 35.35 +/- 8.19 years) with a 10.2 +/- 9.2 year history of 
      AS who met the modified New York criteria) and had its activity defined as the 
      Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >/= 4 scores and an 
      inadequate response to and intolerance of >/= 2 NSAIDs; there were 13 (65%) men. MP 
      was given in a single intravenous dose of 500 mg. The main efficiency criterion 
      (primary study endpoint) was considered to be the number of patients who had 
      achieved an ASAS20 response at week 2. Additional rating criteria (secondary 
      endpoints) (improved BASDAI/ASDAS; decreased erythrocyte sedimentation rate (ESR) 
      and C-reactive protein (CRP) levels; the number of patients achieving 
      ASAS20/40/5/6 responses and ASAS partial remission, and improved ASDAS) were 
      calculated 2, 4, and 12 weeks after MP administration. Safety was monitored 
      estimating the frequency of adverse events (AEs) and controlling vital functions 
      and laboratory indicators. RESULTS: Nine (45%) patients achieved an ASAS40 
      response at week 2. ASDAS was 3.48 at baseline and 2.21 at week 2 (p < 0.0001). 
      ASDAS clinical improvement was established in 11 (55%) patients at week 2. There 
      were decreases in BASDAI from 6.6 to 3.7 at week 2, to 3.5 at week 4, and to 3.2 
      at week 12 (p < 0.001). CRP levels declined from 6.1 to 3.15 mg/l at week 2 (p < 
      0.05), to 2.85 mg/l at week 4 (p < 0.001), and to 4.6 mg/l at week 12 (p < 0.05). 
      ESR was 6.5 mm/h at baseline, 5.5 mm/h at week 2 (p < 0.05), 6.0 mm/h at week 4, 
      and 7.0 mm/h at week 12 (p > 0.05). A total of 13 AEs were recorded and no 
      serious AEs were noted. CONCLUSION: Pulse therapy with MP 500 mg is safe and 
      effective in the short-term treatment of patients with active AS who have 
      achieved no benefits of NSAIDs.
FAU - Gaydukova, I Z
AU  - Gaydukova IZ
AD  - V.I. Razumovsky Saratov State Medical University, Ministry of Health of Russia, 
      Saratov, Russia.
FAU - Rebrov, A P
AU  - Rebrov AP
AD  - V.I. Razumovsky Saratov State Medical University, Ministry of Health of Russia, 
      Saratov, Russia.
FAU - Poddubnyi, D A
AU  - Poddubnyi DA
AD  - Department of Rheumatology, Charite Universitatsmedizin Berlin, Germany.
LA  - rus
PT  - Clinical Trial
PT  - English Abstract
PT  - Journal Article
PL  - Russia (Federation)
TA  - Ter Arkh
JT  - Terapevticheskii arkhiv
JID - 2984818R
RN  - 0 (Anti-Inflammatory Agents)
RN  - X4W7ZR7023 (Methylprednisolone)
SB  - IM
MH  - Administration, Intravenous
MH  - Adult
MH  - Anti-Inflammatory Agents/administration & dosage/adverse effects/*pharmacology
MH  - Female
MH  - Humans
MH  - Male
MH  - Methylprednisolone/administration & dosage/adverse effects/*pharmacology
MH  - Middle Aged
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Spondylitis, Ankylosing/*drug therapy
MH  - Treatment Outcome
EDAT- 2015/07/15 06:00
MHDA- 2015/08/12 06:00
CRDT- 2015/07/10 06:00
PHST- 2015/07/10 06:00 [entrez]
PHST- 2015/07/15 06:00 [pubmed]
PHST- 2015/08/12 06:00 [medline]
AID - 10.17116/terarkh201587547-52 [doi]
PST - ppublish
SO  - Ter Arkh. 2015;87(5):47-52. doi: 10.17116/terarkh201587547-52.