PMID- 26755098
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20161230
IS  - 2213-2201 (Electronic)
VI  - 4
IP  - 2
DP  - 2016 Mar-Apr
TI  - Sequential Treatment Initiation with Timothy Grass and Ragweed Sublingual 
      Immunotherapy Tablets Followed by Simultaneous Treatment Is Well Tolerated.
PG  - 301-9.e2
LID - S2213-2198(15)00647-9 [pii]
LID - 10.1016/j.jaip.2015.11.004 [doi]
AB  - BACKGROUND: Dual treatment with grass and ragweed sublingual immunotherapy (SLIT) 
      tablets has not been studied. OBJECTIVE: To characterize the safety and 
      tolerability of dual grass and ragweed SLIT-tablet administration. METHODS: This 
      open-label, multicenter trial (NCT02256553) enrolled North American adults (N = 
      102) allergic to grass and ragweed. The trial had 3 periods, each of 2 weeks 
      duration. In period 1, subjects received once-daily timothy grass SLIT tablet 
      (2800 bioequivalent allergen unit; Merck, Inc, Kenilworth, NJ/ALK, Horsholm, 
      Denmark). In period 2, subjects received a short ragweed SLIT tablet (12 Ambrosia 
      artemisiifolia 1-U; Merck/ALK) every morning and a grass SLIT tablet every 
      evening. In period 3, subjects received once-daily grass and ragweed SLIT tablets 
      within 5 minutes (simultaneous intake). The primary end point was the proportion 
      of subjects with 1 or more local swelling events in each period. Secondary end 
      points were the proportion of subjects with 1 or more local adverse events (AEs), 
      that discontinued the treatment because of AEs, and subjects with 1 or more local 
      AEs requiring treatment. RESULTS: No severe swellings, systemic allergic 
      reactions, asthma attacks, or reactions requiring epinephrine were reported. Most 
      (99%) AEs were graded mild to moderate. The proportions of subjects with 1 or 
      more local swelling events were 14%, 22%, and 15% for periods 1, 2, and 3, 
      respectively. For periods 1, 2, and 3, the proportions of subjects with 1 or more 
      local AEs were 71%, 69%, and 56%, respectively; the proportions discontinuing the 
      treatment because of treatment-related AEs were 5%, 1%, and 2%, and the 
      proportions with 1 or more local AEs requiring treatment were 4%, 4%, and 1%. 
      CONCLUSIONS: In this trial, a 4-week sequential SLIT-tablet dosing schedule 
      followed by simultaneous intake of timothy grass and ragweed tablets was well 
      tolerated.
CI  - Copyright (c) 2015 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Maloney, Jennifer
AU  - Maloney J
AD  - Merck & Co., Inc, Kenilworth, NJ.
FAU - Berman, Gary
AU  - Berman G
AD  - Clinical Research Institute, Inc, Minneapolis, Minn.
FAU - Gagnon, Remi
AU  - Gagnon R
AD  - Clinique Specialisee en Allergie de la Capitale, Quebec, QC, Canada.
FAU - Bernstein, David I
AU  - Bernstein DI
AD  - Bernstein Clinical Research Center and Division of Immunology and Allergy, 
      University of Cincinnati, Cincinnati, Ohio.
FAU - Nelson, Harold S
AU  - Nelson HS
AD  - National Jewish Health, Denver, Colo.
FAU - Kleine-Tebbe, Jorg
AU  - Kleine-Tebbe J
AD  - Allergy & Asthma Center Westend, Berlin, Germany.
FAU - Kaur, Amarjot
AU  - Kaur A
AD  - Merck & Co., Inc, Kenilworth, NJ.
FAU - Li, Qing
AU  - Li Q
AD  - Merck & Co., Inc, Kenilworth, NJ.
FAU - Nolte, Hendrik
AU  - Nolte H
AD  - Merck & Co., Inc, Kenilworth, NJ. Electronic address: hendrik.nolte@merck.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT02256553
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20160102
PL  - United States
TA  - J Allergy Clin Immunol Pract
JT  - The journal of allergy and clinical immunology. In practice
JID - 101597220
RN  - 0 (Allergens)
RN  - 0 (Antigens, Plant)
RN  - 0 (Tablets)
SB  - IM
MH  - Adult
MH  - Allergens/*therapeutic use
MH  - Ambrosia/immunology
MH  - Antigens, Plant/*therapeutic use
MH  - Canada
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Phleum/immunology
MH  - Rhinitis, Allergic, Seasonal/immunology/*therapy
MH  - Sublingual Immunotherapy/*methods
MH  - Tablets
MH  - United States
OTO - NOTNLM
OT  - Allergic rhinitis
OT  - Dual
OT  - Grass
OT  - Immunotherapy
OT  - Immunotherapy tablet
OT  - Ragweed
OT  - Safety
OT  - Simultaneous
OT  - Sublingual
EDAT- 2016/01/13 06:00
MHDA- 2016/12/15 06:00
CRDT- 2016/01/13 06:00
PHST- 2015/09/17 00:00 [received]
PHST- 2015/11/04 00:00 [revised]
PHST- 2015/11/09 00:00 [accepted]
PHST- 2016/01/13 06:00 [entrez]
PHST- 2016/01/13 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
AID - S2213-2198(15)00647-9 [pii]
AID - 10.1016/j.jaip.2015.11.004 [doi]
PST - ppublish
SO  - J Allergy Clin Immunol Pract. 2016 Mar-Apr;4(2):301-9.e2. doi: 
      10.1016/j.jaip.2015.11.004. Epub 2016 Jan 2.