Treatment Characteristics of Chronic Low Back Pain Patients Treated with Buprenorphine Buccal Film or Transdermal Patch

Figures & data

Figure 1. Study design.

Figure 2. Patient selection flow diagram.

OUD: Opioid use disorder.

Table 1. CIII Buprenorphine treatment characteristics and switching trends in a matched population.

Treatment characteristics	Belbuca^® (n = 1301)	Buprenorphine patch (n = 1301)	p-value ^†
Number of buprenorphine prescriptions, mean (SD)	3.4 (2.4)	3.7 (2.6)	0.011
Number of buprenorphine prescriptions, median (IQR)	3.0 (5.0)	3.0 (5.0)	–
Treatment duration (days), mean (SD)	87.2 (59.0)	91.9 (60.0)	0.043
Treatment duration (days), median (IQR)	60.0 (117.5)	79.0 (129.0)	–
Buprenorphine daily dose (mcg), mean (SD)	501.7 (352.0)	270.9 (153.7)	< 0.001
Buprenorphine daily dose (mcg), median (IQR)	365.6 (327.7)	240.0 (156.9)	–
Switching patterns
Proportion of patients who switched from the initial to other CIII buprenorphine treatment, n (%)	50 (3.8)	149 (11.5)	< 0.001
Buprenorphine daily dose before switch (mcg), mean (SD)	381.6 (292.2)	297.1 (177.2)	0.059
Buprenorphine daily dose before switch (mcg), median (IQR)	300.0 (201.2)	240.0 (134.9)	–
Time to switch (days), mean (SD)	65.1 (52.1)	77.8 (48.2)	0.115
Time to switch (days), median (IQR)	52.0 (71.0)	62.0 (75.5)	–

† χ-square test was performed for categorical variables and independent t-test for continuous variables.

IQR: Interquartile range; SD: Standard deviation.

Table 2. Opioid utilization and treatment characteristics during the 6-month pre-index period in the matched population.

Opioids (SAOs or LAOs)	Belbuca^® (n = 1301)	Buprenorphine patch (n = 1301)	p-value ^†
Opioid treatment duration (days) ^‡ , mean (SD)	104.2 (67.6)	89.8 (68.2)	< 0.001
Opioid treatment duration (days) ^‡ , median (IQR)	136.0 (135.0)	99.0 (145.0)	–
Number of opioid prescriptions ^‡ , mean (SD)	5.7 (4.1)	4.9 (3.8)	< 0.001
Number of opioid prescriptions ^‡ , median (IQR)	6.0 (6.0)	5.0 (5.0)	–
Opioids daily dose (MME) ^‡ , mean (SD)	51.5 (49.2)	39.8 (35.2)	< 0.001
Opioids daily dose (MME) ^‡ , median (IQR)	40.5 (42.9)	33.6 (32.0)	–
Number of patients with at least one opioid prescription, n (%)	1127 (86.6)	1112 (85.5)	0.396
Short-acting opioids
Number of SAO prescriptions ^‡ , mean (SD)	4.8 (3.4)	4.4 (3.4)	0.005
Number of SAO prescriptions ^‡ , median (IQR)	6.0 (5.0)	5.0 (5.0)	–
Number of patients with at least one SAO prescription, n (%)	1096 (84.2)	1101 (84.6)	0.787
Long-acting opioids
Number of LAO prescriptions ^‡ , mean (SD)	0.9 (2.0)	0.5 (1.4)	< 0.001
Number of LAO prescriptions ^‡ , median (IQR)	0.0 (0.0)	0.0 (0.0)	–
Number of patients with at least one LAO prescription, n (%)	276 (21.2)	169 (13.0)	< 0.001

† χ-square test was performed for categorical variables and independent t-test for continuous variables.

‡ Across the total sample.

IQR: Interquartile range; LAO: Long-acting opioid; MME: Morphine milligram equivalent; SAO: Short-acting opioid; SD: Standard deviation.

Table 3. Non-opioid rescue medication utilization during the 6-month pre-index period in the matched population.

Non-opioid rescue medications	Belbuca^® (n = 1301)	Buprenorphine patch (n = 1301)	p-value ^†
Number of NRM prescriptions ^‡ , mean (SD)	4.8 (4.5)	5.2 (4.6)	0.021
Number of NRM prescriptions ^‡ , median (IQR)	4.0 (6.0)	4.0 (7.0)	–
Number of patients with at least one NRM prescription, n (%)	1051 (80.8)	1093 (84.0)	0.031
Nonsteroidal anti-inflammatory drugs
Number of NSAID prescriptions ^‡ , mean (SD)	2.1 (2.7)	2.3 (2.8)	0.061
Number of NSAID prescriptions ^‡ , median (IQR)	1.0 (3.0)	1.0 (4.0)	–
Number of patients with at least one NSAID prescription, n (%)	721 (55.4)	776 (59.6)	0.029
Topiramate
Number of topiramate prescriptions ^‡ , mean (SD)	0.3 (1.0)	0.3 (1.0)	0.786
Number of topiramate prescriptions ^‡ , median (IQR)	0.0 (0.0)	0.0 (0.0)	–
Number of patients with at least one topiramate prescription, n (%)	112 (8.6)	111 (8.5)	0.944
Duloxetine
Number of duloxetine prescriptions ^‡ , mean (SD)	0.7 (1.7)	0.8 (1.8)	0.223
Number of duloxetine prescriptions ^‡ , median (IQR)	0.0 (0.0)	0.0 (0.0)	–
Number of patients with at least one duloxetine prescription, n (%)	273 (21.0)	307 (23.6)	0.109
Gabapentin/pregabalin
Number of gabapentin/pregabalin prescriptions ^‡ , mean (SD)	1.8 (2.4)	1.9 (2.4)	0.146
Number of gabapentin/pregabalin prescriptions ^‡ , median (IQR)	0.0 (3.0)	1.0 (4.0)	–
Number of patients with at least one gabapentin/pregabalin prescription, n (%)	638 (49.0)	701 (53.9)	0.013

† χ-square test was performed for categorical variables and independent t-test for continuous variables.

‡ Across the total sample.

IQR: Interquartile range; NRM: Non-opioid rescue medication; SD: Standard deviation.

Table 4. Opioid utilization and treatment characteristics during the 6-month post-index period in the matched population.

6-month post-index period	Belbuca^® (n = 1301)	Buprenorphine patch (n = 1301)	p-value ^†
Opioids (SAOs or LAOs)
Opioid treatment duration (days) ^‡ , mean (SD)	90.8 (70.3)	82.2 (69.3)	0.002
Opioid treatment duration (days) ^‡ , median (IQR)	107.0 (151.0)	81.0 (150.0)	–
Number of opioid prescriptions ^‡ , mean (SD)	4.6 (3.8)	4.2 (3.9)	0.004
Number of opioid prescriptions ^‡ , median (IQR)	5.0 (6.0)	4.0 (5.0)	–
Opioids daily dose (MME) ^‡ , mean (SD)	38.9 (38.3)	32.5 (32.2)	< 0.001
Opioids daily dose (MME) ^‡ , median (IQR)	31.6 (44.2)	28.6 (37.4)	–
Number of patients with at least one opioid prescription, n (%)	1027 (78.9)	999 (76.8)	0.186
Time to opioid (days) ^§ , mean (SD)	29.6 (38.5)	31.4 (38.6)	0.310
Time to opioid (days) ^§ , median (IQR)	18.0 (29.0)	20.0 (36.0)	–
Number of buprenorphine prescriptions before opioid ^§ , mean (SD)	1.4 (0.9)	1.4 (1.0)	0.204
Number of buprenorphine prescriptions before opioid ^§ , median (IQR)	1.0 (0.0)	1.0 (0.0)	–
Short-acting opioids
Number of SAO prescriptions ^‡ , mean (SD)	4.1 (3.2)	3.9 (3.6)	0.066
Number of SAO prescriptions ^‡ , median (IQR)	5.0 (5.0)	4.0 (5.0)	–
Number of patients with at least one SAO prescription, n (%)	1018 (78.2)	986 (75.8)	0.136
Time to SAO (days) ^§ , mean (SD)	30.5 (39.2)	32.0 (38.9)	0.382
Time to SAO (days) ^§ , median (IQR)	19.0 (30.0)	21.0 (37.0)	–
Number of buprenorphine prescriptions before SAO ^§ , mean (SD)	1.4 (0.9)	1.4 (1.0)	0.334
Number of buprenorphine prescriptions before SAO ^§ , median (IQR)	1.0 (0.0)	1.0 (0.0)	–
Long-acting opioids
Number of LAO prescriptions ^‡ , mean (SD)	0.5 (1.5)	0.3 (1.2)	< 0.001
Number of LAO prescriptions ^‡ , median (IQR)	0.0 (0.0)	0.0 (0.0)	–
Number of patients with at least one LAO prescription, n (%)	169 (13.0)	122 (9.4)	0.003
Time to LAO (days) ^§ , mean (SD)	62.2 (49.2)	58.8 (52.7)	0.578
Time to LAO (days) ^§ , median (IQR)	51.0 (66.5)	36.5 (80.3)	–
Number of buprenorphine prescriptions before LAO ^§ , mean (SD)	1.7 (1.1)	2.0 (1.6)	0.030
Number of buprenorphine prescriptions before LAO ^§ , median (IQR)	1.0 (1.0)	1.0 (2.0)	–

† χ-square test was performed for categorical variables and independent t-test for continuous variables.

‡ Across the total sample.

§ Considering only patients who were prescribed at least one medication of interest.

IQR: Interquartile range; LAO: Long-acting opioid; MME: Morphine milligram equivalent; SAO: Short-acting opioid; SD: Standard deviation.

Table 5. Non-opioid rescue medication utilization during the 6-month post-index period in the matched population.

Non-opioid rescue medications	Belbuca^® (n = 1301)	Buprenorphine patch (n = 1301)	p-value ^†
Number of NRM prescriptions ^‡ , mean (SD)	4.6 (4.4)	4.9 (4.6)	0.074
Number of NRM prescriptions ^‡ , median (IQR)	4.0 (6.0)	4.0 (6.0)	–
Number of patients with at least one NRM prescription, n (%)	1017 (78.2)	1053 (80.9)	0.080
Nonsteroidal anti-inflammatory drugs
Number of NSAID prescriptions ^‡ , mean (SD)	1.8 (2.7)	2.0 (2.8)	0.151
Number of NSAID prescriptions ^‡ , median (IQR)	1.0 (3.0)	1.0 (3.0)	–
Number of patients with at least one NSAID prescription, n (%)	662 (50.9)	712 (54.7)	0.050
Topiramate
Number of topiramate prescriptions ^‡ , mean (SD)	0.2 (1.0)	0.2 (1.0)	0.841
Number of topiramate prescriptions ^‡ , median (IQR)	0.0 (0.0)	0.0 (0.0)	–
Number of patients with at least one topiramate prescription, n (%)	96 (7.4)	104 (8.0)	0.556
Duloxetine
Number of duloxetine prescriptions ^‡ , mean (SD)	0.7 (1.7)	0.8 (1.8)	0.260
Number of duloxetine prescriptions ^‡ , median (IQR)	0.0 (0.0)	0.0 (0.0)	–
Number of patients with at least one duloxetine prescription, n (%)	270 (20.8)	293 (22.5)	0.274
Gabapentin/pregabalin
Number of gabapentin/pregabalin prescriptions ^‡ , mean (SD)	1.8 (2.5)	1.9 (2.5)	0.406
Number of gabapentin/pregabalin prescriptions ^‡ , median (IQR)	0.0 (3.0)	0.0 (4.0)	–
Number of patients with at least one gabapentin/pregabalin prescription, n (%)	611 (47.0)	648 (49.8)	0.147

† χ-square test was performed for categorical variables and independent t-test for continuous variables.

‡ Across the total sample.

IQR: Interquartile range; NRM: Non-opioid rescue medication; SD: Standard deviation.

Table 6. Changes in rescue medication utilization after CIII buprenorphine treatment initiation in the matched population.

Belbuca^® (n = 1301)
	6-month pre-index	6-month post-index	Mean difference	p-value ^†
Nonsteroidal anti-inflammatory drugs
Number of NSAID prescriptions, mean (SD)	2.1 (2.7)	1.8 (2.7)	-0.2	< 0.001
Rescue medications (NSAIDs, topiramate, duloxetine, or gabapentin/pregabalin)
Number of non-opioid rescue medication prescriptions, mean (SD)	4.8 (4.5)	4.6 (4.4)	-0.2	0.008
Short-acting opioids
Number of SAO prescriptions, mean (SD)	4.8 (3.4)	4.1 (3.2)	-0.7	< 0.001
Long-acting opioids
Number of LAO prescriptions, mean (SD)	0.9 (2.0)	0.5 (1.5)	-0.4	< 0.001
Opioids (SAOs or LAOs)
Opioid treatment duration (days), mean (SD)	104.2 (67.6)	90.8 (70.3)	-13.4	< 0.001
Number of opioid prescriptions, mean (SD)	5.7 (4.1)	4.6 (3.8)	-1.1	< 0.001
Opioids daily dose (MME), mean (SD)	51.5 (49.2)	38.9 (38.3)	-12.6	< 0.001
Buprenorphine patch (n = 1301)
	6-month pre-index	6-month post-index	Mean difference	p-value ^†
Nonsteroidal anti-inflammatory drugs
Number of NSAID prescriptions, mean (SD)	2.3 (2.8)	2.0 (2.8)	-0.3	< 0.001
Rescue medications (NSAIDs, topiramate, duloxetine, or gabapentin/pregabalin)
Number of non-opioid rescue medication prescriptions, mean (SD)	5.2 (4.6)	4.9 (4.6)	-0.3	< 0.001
Short-acting opioids
Number of SAO prescriptions, mean (SD)	4.4 (3.4)	3.9 (3.6)	-0.6	< 0.001
Long-acting opioids
Number of LAO prescriptions, mean (SD)	0.5 (1.4)	0.3 (1.2)	-0.2	< 0.001
Opioids (SAOs or LAOs)
Opioid treatment duration (days), mean (SD)	89.8 (68.2)	82.2 (69.3)	-7.6	< 0.001
Number of opioid prescriptions, mean (SD)	4.9 (3.8)	4.2 (3.9)	-0.7	< 0.001
Opioids daily dose (MME), mean (SD)	39.8 (35.2)	32.5 (32.2)	-7.3	< 0.001

† Paired-sample test was performed to test differences.

Negative values demonstrate a decreasing trend in the 6-month post-index period, after treatment initiation.

LAO: Long-acting opioid; MME: Morphine milligram equivalent; SAO: Short-acting opioid; SD: Standard deviation.

Table 7. Between-group comparison of rescue medication utilization changes after CIII buprenorphine initiation in the matched population.

Mean difference (6-month post- vs 6-month pre-index)	Belbuca^® (n = 1301)	Buprenorphine patch (n = 1301)	p-value ^†
Nonsteroidal anti-inflammatory drugs
Number of NSAID prescriptions, mean (SD)	-0.2 (2.3)	-0.3 (2.5)	0.597
Rescue medications (NSAIDs, topiramate, duloxetine, or gabapentin/pregabalin)
Number of non-opioid rescue medication prescriptions, mean (SD)	-0.2 (3.4)	-0.3 (3.5)	0.487
Short-acting opioids
Number of SAO prescriptions, mean (SD)	-0.7 (3.3)	-0.6 (3.6)	0.322
Long-acting opioids
Number of LAO prescriptions, mean (SD)	-0.4 (1.9)	-0.2 (1.5)	< 0.001
Opioids (SAOs or LAOs)
Opioid treatment duration (days), mean (SD)	-13.4 (65.6)	-7.6 (62.0)	0.022
Number of opioid prescriptions, mean (SD)	-1.1 (3.9)	-0.7 (4.0)	0.012
Opioids daily dose (MME), mean (SD)	-12.6 (38.6)	-7.3 (31.4)	< 0.001

† Independent t-test was performed to test the difference. The p-values were validated with mixed-model analysis of variance.

Negative values demonstrate a decreasing trend in the 6-month post-index period, after treatment initiation.

LAO: Long-acting opioid; MME: Morphine milligram equivalent; SAO: Short-acting opioid; SD: Standard deviation.