PMID- 23216674
OWN - NLM
STAT- MEDLINE
DCOM- 20130606
LR  - 20220330
IS  - 1471-2377 (Electronic)
IS  - 1471-2377 (Linking)
VI  - 12
DP  - 2012 Dec 6
TI  - Comparative injection-site pain and tolerability of subcutaneous serum-free 
      formulation of interferonbeta-1a versus subcutaneous interferonbeta-1b: results of the 
      randomized, multicenter, Phase IIIb REFORMS study.
PG  - 154
LID - 10.1186/1471-2377-12-154 [doi]
AB  - BACKGROUND: In patients with relapsing-remitting multiple sclerosis (RRMS), 
      subcutaneous (sc) interferon (IFN)beta-1a and IFNbeta-1b have been shown to reduce 
      relapse rates. A formulation of IFNbeta-1a has been produced without fetal bovine 
      serum and without human serum albumin as an excipient (not currently approved for 
      use in the US). The objectives of this study were to evaluate tolerability, 
      injection-site redness, subject-reported satisfaction with therapy, and clinical 
      safety and efficacy of the serum-free formulation of IFNbeta-1a versus IFNbeta-1b in 
      IFNbeta-treatment-naive patients with RRMS. The objectives of the extension phase 
      were to evaluate long-term safety and tolerability of IFNbeta-1a. METHODS: This 
      randomized, parallel-group, open-label study was conducted at 27 clinical sites 
      in the US. Eligible patients aged 18-60 years were randomized to receive either 
      IFNbeta-1a, titrated to 44 mug sc three times weekly (tiw) (n = 65), or IFNbeta-1b, 
      titrated to 250 mug sc every other day (n = 64) over 12 weeks. Following this, all 
      patients received IFNbeta-1a 44 mug tiw for 82-112 weeks. Primary endpoint was mean 
      change in patient-reported pain, as assessed by visual analog scale (VAS) diary 
      pain score (from 0 mm [no pain] to 100 mm [worst possible pain]) at the injection 
      site, from pre-injection to 30 min post-injection over the first 21 full-dose 
      injections. Secondary assessments included proportion of patients pain-free as 
      recorded by VAS diary and the Short-Form McGill Pain questionnaire VAS. RESULTS: 
      A total of 129 patients were included in the intent-to-treat analysis. Mean 
      (standard deviation) change in VAS diary pain score was not significantly 
      different between groups, although numerically lower with IFNbeta-1a versus IFNbeta-1b 
      from pre-injection to immediately post-injection (1.46 [2.93] vs. 4.63 [10.57] 
      mm), 10 min post-injection (0.70 [1.89] vs. 1.89 [5.75] mm), and 30 min 
      post-injection (0.67 [2.32] vs. 1.14 [4.94] mm). Proportion of patients pain-free 
      at all time periods post-injection was also not significantly different between 
      groups. Adverse events were consistent with the known safety profiles of these 
      treatments. CONCLUSIONS: In IFNbeta-treatment-naive patients with RRMS, both the 
      serum-free formulation of IFNbeta-1a and IFNbeta-1b treatments were generally 
      accompanied by low-level injection-site pain and were well tolerated. TRIAL 
      REGISTRATION: ClinicalTrials.gov NCT00428584.
FAU - Singer, Barry
AU  - Singer B
AD  - Missouri Baptist Medical Center, St, Louis, MO, USA. bnvsinger@earthlink.net
FAU - Bandari, Daniel
AU  - Bandari D
FAU - Cascione, Mark
AU  - Cascione M
FAU - LaGanke, Christopher
AU  - LaGanke C
FAU - Huddlestone, John
AU  - Huddlestone J
FAU - Bennett, Randy
AU  - Bennett R
FAU - Dangond, Fernando
AU  - Dangond F
CN  - REFORMS Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT00428584
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20121206
PL  - England
TA  - BMC Neurol
JT  - BMC neurology
JID - 100968555
RN  - 0 (Adjuvants, Immunologic)
RN  - 145155-23-3 (Interferon beta-1b)
RN  - 77238-31-4 (Interferon-beta)
RN  - XRO4566Q4R (Interferon beta-1a)
SB  - IM
MH  - Adjuvants, Immunologic/*administration & dosage/adverse effects
MH  - Adolescent
MH  - Adult
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Interferon beta-1a
MH  - Interferon beta-1b
MH  - Interferon-beta/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis, Relapsing-Remitting/*drug therapy
MH  - Pain/*etiology
MH  - Pain Measurement
MH  - Treatment Outcome
PMC - PMC3541262
EDAT- 2012/12/12 06:00
MHDA- 2013/06/07 06:00
PMCR- 2012/12/06
CRDT- 2012/12/11 06:00
PHST- 2012/07/02 00:00 [received]
PHST- 2012/11/21 00:00 [accepted]
PHST- 2012/12/11 06:00 [entrez]
PHST- 2012/12/12 06:00 [pubmed]
PHST- 2013/06/07 06:00 [medline]
PHST- 2012/12/06 00:00 [pmc-release]
AID - 1471-2377-12-154 [pii]
AID - 10.1186/1471-2377-12-154 [doi]
PST - epublish
SO  - BMC Neurol. 2012 Dec 6;12:154. doi: 10.1186/1471-2377-12-154.