Tolerability of the SQ-standardised grass sublingual immunotherapy tablet in patients treated with concomitant allergy immunotherapy: a non-interventional observational study

Abstract

Background The majority of allergic patients are poly-sensitized. For causal treatment by allergy immunotherapy (AIT) a single or few allergen products containing the clinically most relevant allergens are applied, but few data on tolerability of multiple application of AIT is available. The aim of our study was to investigate safety and tolerability in patients who started treatment by sublingual immunotherapy (SLIT) with the standardised SQ® grass SLIT-tablet and were treated with concomitant AIT products.MethodsIn a non-interventional, open-label, observational study in Germany treatment of patients with the SQ® grass SLIT-tablet and concomitant AIT (SCIT or SLIT) was documented between January 2012 and January 2014. Patients were followed at visits at first administration of the SQ® grass SLIT-tablet and after 1–3 months of treatment. Tolerability of the treatment with the SQ® grass SLIT-tablet and concomitant AIT were assessed by the physician and administration of AIT and adverse events (AEs) were recorded by the patients in diaries. AEs and adverse drug reactions (ADRs) were coded by using the Medical Dictionary for Regulatory Activities.ResultsIn total, 181 patients were documented by 48 allergists and 160 patients treated with a concomitant AIT (SCIT 130, SLIT 30). AEs were reported in 58 (36.3 %) patients with concomitant AIT, and AEs considered related with the SQ® grass SLIT-tablet in 49 (30.6 %) and with concomitant AIT in 18 (11.3 %) patients. Treatment was discontinued due to ADRs in 12 (7.5 %) patients and severity of ADRs was assessed mild or moderate in 29 (18.1 %), and severe in 20 (12.5 %) patients. Most common reactions were localised at the application site of the SQ® grass SLIT-tablet as oral pruritus, throat irritation, oedema mouth and paraesthesia oral; no serious ADRs were reported. Overall tolerability of the SQ® grass SLIT-tablet if given with concomitant AIT was assessed as “good” or “very good” by 91.0 % of patients and 91.6 % of physicians.ConclusionsIn comparison to data from previous studies no increase in frequency of AEs or change in the tolerability profile was observed when SLIT with the SQ® grass SLIT-tablet was administered with concomitant SCIT or SLIT.

Non-Coding RNAs in Human Breast Milk: A Systematic Review

“…Interestingly, these EVs may could subsequently be detected in a wide range of different organs, such as the heart, spleen, lungs, and brain ( 20 ). Hypothetically, breast milk miRNA could hence exert direct effects on immune regulation in the infant, for example by inhibiting the expression of key transcription factors in immune cell polarization ( 21 , 22 ) or epigenetic modifications in immune cell linages ( 23 , 24 ). Other regulatory ncRNA are also present in breast milk, such as long non-coding RNA (lncRNA), short interfering RNA (siRNA), piwi-interacting RNA (piRNA), circular RNA (circRNA) and fragmented tRNAs.…”

Tolerability of an Immunologically Enhanced Subcutaneous Immunotherapy Preparation in Patients Treated with Concomitant Allergy Immunotherapy: A Non-Interventional Observational Study

“…In a study with a similar design investigating the tolerability of the SQ ® grass SLIT-tablet applied with concomitant AIT, no change in the tolerability profile or increase in the frequency of adverse reactions compared with previous studies with the same product have been observed [ 5 ]. No concomitant AIT treatment has been recorded in 11.7% of patients treated with the primary SCIT.…”

“…The tolerability of treatment with the SQ ® grass SLIT-tablet when applied with concomitant AIT has been investigated in a separate study. No change in the tolerability profile and frequency of reactions with the SQ ® grass SLIT-tablet has been observed [ 5 ].…”

Treatment Satisfaction During Routine Treatment with the SQ®-Standardised Grass Allergy Immunotherapy Tablet: A Non-interventional Observational Study

“…Tolerability of treatment with the SQ Ò grass SLIT-tablet in adults and children [21,23], feasibility of an intra-seasonal start of treatment [22] and tolerability in patients treated with concomitant AIT [24] have been investigated in other studies in the real life setting. In our study, treatment satisfaction with the SQ Ò grass SLIT-tablet using the validated TSQM instrument was investigated in the real-life setting.…”

“…The SQ Ò -standardised grass sublingual immunotherapy (SLIT)-tablet contains a fast-dissolving extract of Phleum pratense (timothy grass; GRAZAX Ò ; ALK, Hørsholm, Denmark), which is indicated for the disease-modifying treatment of grass pollen-induced rhinitis and conjunctivitis in adults and children (5 years and older). The tolerability and efficacy of the tablet, including long-term efficacy and disease-modifying effect, has been demonstrated in several randomized controlled trials (RCTs) in Europe and USA [8][9][10][11][12][13][14][15][16][17][18][19][20], and tolerability in adults and children, health-related quality of life and feasibility of intra-seasonal start of treatment in real life have been documented in several non-interventional observational studies [21][22][23][24][25].…”