Clinical Characteristics of Patients and Factors Associated with Switching Biologics in Asthma

Figures & data

Table 1 Demographics of Patients with Asthma in the Continuous and Switched Groups

Characteristics	Switched Group	Continuous Group	P-value
Number of subjects	13	29
Age^†*, years	51.0 (37.0–65.5)	64.0 (50.5–71.0)	0.039
Age at onset of asthma*, years	32.6 (15.3)	43.3 (16.3)	0.050
Female sex	8 (61.5)	22 (75.9)	0.349
Total IgE, IU/mL	265 (130–364)	171.5 (97.9–370)	0.435
Blood eosinophil count* (cells/μL)	706.0 (130.5–1049.5)	298.0 (134.5–517.5)	0.047
Atopy	6 (46.2)	13 (44.8)	0.331
Pulmonary function tests
FEV1, L	2.00 (1.69–2.52)	1.58 (1.02–2.07)	0.333
FEV1, % predicted (%)	76.0 ± 6.1	76.3 ± 4.5	0.644
FEV1/FVC<70%	8 (61.5)	21 (72.4)	0.485
FeNO (ppb)	62.5 (14.8–106.8)	44.0 (24.0–66.0)	0.173
Treatment
ICS dose^‡(μg)	1800 (1500–2800)	1600 (1500–2320)	0.193
Maintenance OCS use	5 (38.5)	14 (63.6)	0.149
LAMA use	13 (44.8)	4 (25.0)	0.189
LTRA use	12 (75.0)	22 (75.9)	0.949
Biologics at baseline* (Oma/Mep/Ben/Dup)	0/8/5/0	10/3/11/5	0.001
Biologics after switching (Oma/Mep/Ben/Dup)	1/2/4/6	10/3/11/5	0.115
Comorbidities
AR	4 (26.7)	6 (20.7)	0.765
JESREC 11 or higher^§,*	8 (61.5)	8 (27.6)	0.036
EOM	4 (25.0)	11 (37.9)	0.336
AERD*	6 (46.2)	3 (10.3)	0.011

Notes: Data are shown as the mean ± standard deviation, median (interquartile range), or number (%). P-values were obtained using the chi-square test, Student’s t-test or the Kruskal–Wallis test, as appropriate. *P< 0.05 ^†Age at the time of introduction of biologics. ^‡Equivalent to budesonide dose. ^§ECRS was defined as JESREC 11 or higher.

Abbreviations: AERD, aspirin-exacerbated respiratory disease; AR, allergic rhinitis; ben, benralizumab; dup, dupilumab; ECRS, eosinophilic chronic rhinosinusitis; EOM, eosinophilic otitis media; FeNO, fractional exhaled nitric oxide; FEV₁, forced expiratory volume in 1 s; FVC, forced vital capacity; ppb, parts per billion; ICS, inhaled corticosteroids; JESREC, Japanese Epidemiological Survey of Refractory Eosinophilic Chronic Rhinosinusitis; LAMA, long-acting muscarinic antagonist; LTRA, Leukotriene Receptor Antagonist; mep, mepolizumab; oma, omalizumab.

Table 2 Factors Related to Eosinophilic Chronic Rhinosinusitis in the Continuous and Switched Groups

Characteristics	Switched Group	Continuous Group	P-value
Number of subjects	13	29
JESREC score*, points	11.0 (7.5–17.0)	8.0 (4.0–10.5)	0.030
Olfactory cleft lesion*	7 (54)	4 (14)	0.008
Nasal polyp*	6 (55)	5 (20)	0.042
Affected side: both sides	8 (73)	10 (42)	0.083
Ethmoid-dominant inflammation	7 (64)	7 (29)	0.054
Severe ECRS	5 (71)	4 (57)	0.833
CT grading score (Lund-Mackay), point	11 (0–20.0)	1 (0–6.8)	0.150

Notes: Data are shown as the median (interquartile range), or number (%). P-values were obtained using the chi-square test or the Kruskal–Wallis test, as appropriate. *P < 0.05.

Abbreviations: ECRS, eosinophilic chronic rhinosinusitis; JESREC, Japanese Epidemiological Survey of Refractory Eosinophilic Chronic Rhinosinusitis; CT, computed tomography.

Figure 1 Frequency of switching biologics in the switched group. Switching biologics was observed once in six patients, twice in five patients, and three times in two patients.

Table 3 Associated Factors with Time to Switch Biologics

Variable	Hazard Ratio (95% CI)	P-value
Age^†*	0.91 (0.84–0.96)	0.004
Female sex	0.20 (0.01–2.67)	0.224
FEV1, % predicted	1.03 (0.46–1.08)	0.137
JESREC, ≥11*	20.8 (1.78–240.9)	0.015
AERD	0.41 (0.06–2.8)	0.362

Notes: *P< 0.05. ^†Age at time of biologics introduction.

Abbreviations: AERD, aspirin-exacerbated respiratory disease; FEV₁, forced expiratory volume in 1 s; JESREC, Japanese Epidemiological Survey of Refractory Eosinophilic Chronic Rhinosinusitis.

Figure 2 Kaplan–Meier curves for time to switch the biologics. (A) The subgroup analysis on JESREC score. The time to switch biologics was significantly shorter in the subgroup with the JESREC score of 11 or higher than that with the JESREC score <11 (P <0.05). (B) The subgroup analysis on AERD. The time to switch biologics was significantly shorter in the subgroup with AERD than that without AERD (P <0.05).