PMID- 27668697
OWN - NLM
STAT- MEDLINE
DCOM- 20170113
LR  - 20191210
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 54
IP  - 11
DP  - 2016 Nov
TI  - Evaluation of a novel autoinjector for subcutaneous self-administration of 
      belimumab in systemic lupus erythematosus
.
PG  - 914-922
AB  - OBJECTIVE: To study self-administration and pharmacokinetics (PK) of subcutaneous 
      (SC) belimumab in patients with systemic lupus erythematosus (SLE). METHODS: 
      Patients previously treated with belimumab self-administered belimumab 200 mg SC 
      weekly for 8 weeks using an autoinjector. The primary endpoint was the proportion 
      of patients able to self-administer their first and second dose (weeks 1 and 2) 
      in the clinic. The proportion able to self-administer at weeks 4 and 8 (clinic) 
      and weeks 3, 5, 6, and 7 (home) were secondary endpoints. Belimumab PK, safety, 
      and injection-site pain were assessed. RESULTS: 91/95 patients completed the 
      study (withdrawals: adverse events (AEs): 3; lost to follow-up: 1). 93% were 
      female, and mean (SD) age was 44.8 (12.50) years. The majority (99%, 89/90; no 
      attempt, n = 5) successfully self-administered belimumab SC at weeks 1 and 2 (5 
      had clinic staff assistance), and 98% (85/87) successfully self-administered at 
      weeks 4 and 8. Home-administration success rates were high (93%, (81/87) at weeks 
      3, 5, 6, and 7). Week 8 median trough concentration was 113 microg/mL. For patients 
      with a </= 1.5-week interval between IV SC administration, week-1 concentrations 
      were higher vs. week 8 (+ 51% median) but within a range observed with IV dosing; 
      those with a >/= 2.5-week interval had median differences close to 0. AEs and 
      serious AEs were low, with no deaths; pain levels were low and decreased with 
      subsequent injections. CONCLUSION: Patients with SLE successfully 
      self-administered belimumab SC using a novel autoinjector; the PK profile was 
      stable following a switch from IV with acceptable AE and pain levels. The 
      recommended dosing interval between IV to SC dosing is 1 - 4 weeks.
.
FAU - Sheikh, Saira Z
AU  - Sheikh SZ
FAU - Hammer, Anne E
AU  - Hammer AE
FAU - Fox, Norma Lynn
AU  - Fox NL
FAU - Groark, James
AU  - Groark J
FAU - Struemper, Herbert
AU  - Struemper H
FAU - Roth, David
AU  - Roth D
FAU - Gordon, David
AU  - Gordon D
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunosuppressive Agents)
RN  - 73B0K5S26A (belimumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse 
      effects/*therapeutic use
MH  - Endpoint Determination
MH  - Equipment Failure/statistics & numerical data
MH  - Female
MH  - Home Care Services
MH  - Humans
MH  - Immunosuppressive Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Injections, Intravenous
MH  - Injections, Subcutaneous/adverse effects/*instrumentation
MH  - Lupus Erythematosus, Systemic/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Pain/epidemiology/etiology
MH  - Patient Safety
MH  - Self Administration
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC5100660
EDAT- 2016/10/22 06:00
MHDA- 2017/01/14 06:00
PMCR- 2016/11/01
CRDT- 2016/09/27 06:00
PHST- 2016/10/19 00:00 [accepted]
PHST- 2016/10/22 06:00 [pubmed]
PHST- 2017/01/14 06:00 [medline]
PHST- 2016/09/27 06:00 [entrez]
PHST- 2016/11/01 00:00 [pmc-release]
AID - 14764 [pii]
AID - 10.5414/CP202623 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2016 Nov;54(11):914-922. doi: 10.5414/CP202623.