PMID- 29764238
OWN - NLM
STAT- MEDLINE
DCOM- 20190204
LR  - 20190215
IS  - 1744-7593 (Electronic)
IS  - 1742-5247 (Linking)
VI  - 15
IP  - 6
DP  - 2018 Jun
TI  - Successful administration of BI 695501, an adalimumab biosimilar, using an 
      autoinjector (AI): results from a Phase II open-label clinical study 
      (VOLTAIRE((R))-RL).
PG  - 545-548
LID - 10.1080/17425247.2018.1472572 [doi]
AB  - BACKGROUND: This study examined the patient handling experience and 
      self-injection success of patients with rheumatoid arthritis (RA) administering 
      BI 695501 using an AI. METHODS: This Phase II, 7-week, open-label, interventional 
      study (NCT02636907) included adult patients with moderately to severely active RA 
      not adequately controlled by DMARDs, with no experience of self-injecting with 
      AI/pen. Patients self-injected BI 695501 via AI every 2 weeks in the AI 
      Assessment Period (AAP). Training was given on first injection; AI handling 
      events were recorded. Percentage of self-injection success was the primary end 
      point. Patients could enter a 42-week pre-filled syringe (PFS) safety extension. 
      RESULTS: The AAP was completed by 73/77 patients. In total, 216/218 (99.1%) 
      self-injections on Days 15, 29, and 43, were successful. Nine (11.7%) patients 
      had drug-related adverse events (AEs). Two patients reported four serious AEs 
      (SAEs), none drug-related. Overall (in the AAP and PFS extension), 28 (36.4%) 
      patients had drug-related AEs; nine patients had SAEs, one was considered 
      drug-related. Five (6.5%) patients reported injection-site reactions in the AAP; 
      13 (18.1%) in the PFS extension. CONCLUSIONS: After training, almost all patients 
      were successfully able to self-administer BI 695501 using an AI. BI 695501 via AI 
      (and via PFS in the extension) was well tolerated. CLINICAL TRIAL REGISTRATION: 
      NCT02636907.
FAU - Cohen, Stanley
AU  - Cohen S
AD  - a Metroplex Clinical Research Center , Dallas , USA.
FAU - Klimiuk, Piotr A
AU  - Klimiuk PA
AD  - b Medical University of Bialystok and Gabinet Internistyczno-Reumatologiczny , 
      Bialystok , Poland.
FAU - Krahnke, Tillmann
AU  - Krahnke T
AD  - c Cogitars GmbH , Heidelberg , Germany.
FAU - Assudani, Deepak
AU  - Assudani D
AD  - d Boehringer Ingelheim , Ingelheim a.R. , Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT02636907
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180515
PL  - England
TA  - Expert Opin Drug Deliv
JT  - Expert opinion on drug delivery
JID - 101228421
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
MH  - Adalimumab/*administration & dosage
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antirheumatic Agents/*administration & dosage
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Biosimilar Pharmaceuticals/*administration & dosage
MH  - Female
MH  - Humans
MH  - Injections
MH  - Male
MH  - Middle Aged
MH  - Self Administration
MH  - Syringes
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Adalimumab
OT  - BI 695501
OT  - autoinjector
OT  - biosimilar
OT  - rheumatoid arthritis
EDAT- 2018/05/17 06:00
MHDA- 2019/02/05 06:00
CRDT- 2018/05/17 06:00
PHST- 2018/05/17 06:00 [pubmed]
PHST- 2019/02/05 06:00 [medline]
PHST- 2018/05/17 06:00 [entrez]
AID - 10.1080/17425247.2018.1472572 [doi]
PST - ppublish
SO  - Expert Opin Drug Deliv. 2018 Jun;15(6):545-548. doi: 
      10.1080/17425247.2018.1472572. Epub 2018 May 15.