. 2023 Apr;29(4):10.18553/jmcp.2023.29.4.365. doi: 10.18553/jmcp.2023.29.4.365

TABLE 1.

Patient Baseline Demographics, Disease Characteristics, and Disease Severity for the Prevalent OCS Use Cohort Exposure Categories and the No OCS Use Cohort (N = 37,726)

	No OCS use (n = 21,517)	0 periods of prevalent OCS use (n = 5,390)	1 period of prevalent OCS use (n = 4,491)	2 periods of prevalent OCS use (n = 6,328)
Age, mean (SD), y	49.4 (13.9)	46.7 (13.7)^a	45.6 (13.9)^a	45.8 (13.6)^a
Age category, n (%)
5-17 y	368 (1.7)	173 (3.2)^a	161 (3.6)^a	195 (3.1)^a
≥18 y	21,149 (98.3)	5,217 (96.8)^a	4,330 (96.4)^a	6,133 (96.9)^a
Sex, n (%)^b
Female	18,823 (87.5)	4,801 (89.1)^a	3,925 (87.4)^c	5,468 (86.4)^d
Male	2,693 (12.5)	589 (10.9)^a	566 (12.6)	860 (13.6)^d
Region, n (%)
South	6,590 (30.6)	1,996 (37.0)^a	1,605 (35.7)^a	2,409 (38.1)^a
Northeast	5,514 (25.6)	1,096 (20.3)^a	959 (21.4)^a	1,351 (21.3)^a
Midwest	5,048 (23.5)	1,387 (25.7)^a	1,181 (26.3)^a	1,556 (24.6)^c
West	4,128 (19.2)	864 (16.0)^a	704 (15.7)^a	947 (15.0)^a
Unknown	236 (1.1)	47 (0.9)^c	42 (0.9)^c	65 (1.0)^c
Insurance type, n (%)^e
Commercial	12,591 (58.5)	3,150 (58.4)^c	2,645 (58.9)^c	3,717 (58.7)^c
Medicare	596 (2.8)	108 (2.0)^a	86 (1.9)^a	129 (2.0)^a
Medicaid	1,632 (7.6)	366 (6.8)^d	310 (6.9)^c	462 (7.3)^c
Self-insured	6,585 (30.6)	1,804 (33.5)^a	1,448 (32.2)^d	2,046 (32.3)^a
Other/unknown	204 (0.9)	16 (0.3)^a	23 (0.5)^a	15 (0.2)^a
Year of index date, n (%)
2006-2007	309 (1.4)	728 (13.5)^a	607 (13.5)^a	1,121 (17.7)^a
2008-2009	3,621 (16.8)	888 (16.5)^c	750 (16.7)^c	1,105 (17.5)^c
2010-2011	4,203 (19.5)	824 (15.3)^a	694 (15.5)^a	976 (15.4)^a
2012-2013	3,911 (18.2)	898 (16.7)^a	811 (18.1)^c	1,081 (17.1)^d
2014-2015	4,063 (18.9)	1,145 (21.2)^a	906 (20.2)^d	1,119 (17.7)^d
2016-2017	4,609 (21.4)	803 (14.9)^a	646 (14.4)^a	835 (13.2)^a
2018	801 (3.7)	104 (1.9)^a	77 (1.7)^a	91 (1.4)^a
Physician specialty, n (%)^f
Primary care physician	2,358 (11.0)	870 (16.1)^a	758 (16.9)^a	1,091 (17.2)^a
Rheumatologist	2,481 (11.5)	1,383 (25.7)^a	1,103 (24.6)^a	1,501 (23.7)^a
Quan-Charlson comorbidity index, mean (SD)	0.9 (1.1)	1.5 (1.1)^a	1.6 (1.2)^a	1.7 (1.3)^a
Comorbidities, n (%)^e,g
Cardiovascular disease	6,523 (30.3)	2,054 (38.1)^a	1,932 (43.0)^a	2,915 (46.1)^a
Hypertension	5,936 (27.6)	1,897 (35.2)^a	1,749 (38.9)^a	2,633 (41.6)^a
Cerebrovascular disease	773 (3.6)	197 (3.7)^c	241 (5.4)^a	356 (5.6)^a
Congestive heart failure	532 (2.5)	205 (3.8)^a	227 (5.1)^a	410 (6.5)^a
Peripheral vascular disease	589 (2.7)	161 (3.0)^c	183 (4.1)^a	297 (4.7)^a
Myocardial infarction	187 (0.9)	46 (0.9)^c	63 (1.4)^a	109 (1.7)^a
Stroke	201 (0.9)	59 (1.1)^c	58 (1.3)^d	104 (1.6)^a
Infections	7,480 (34.8)	2,012 (37.3)^a	1,858 (41.4)^a	2,691 (42.5)^a
Immuno-inflammation–related	1,876 (8.7)	1,088 (20.2)^a	935 (20.8)^a	1,365 (21.6)^a
Rheumatoid arthritis	1,497 (7.0)	975 (18.1)^a	819 (18.2)^a	1,175 (18.6)^a
Thyroiditis	275 (1.3)	62 (1.2)^c	61 (1.4)^c	96 (1.5)^c
Inflammatory bowel disease	150 (0.7)	77 (1.4)^a	92 (2.0)^a	153 (2.4)^a
Renal disease	1,130 (5.3)	751 (13.9)^a	793 (17.7)^a	1,042 (16.5)^a
Diabetes	2,072 (9.6)	489 (9.1)^c	472 (10.5)^c	832 (13.1)^a
Osteoporosis	1,108 (5.1)	523 (9.7)^a	426 (9.5)^a	741 (11.7)^a
Concomitant medications, n (%)^e,h
Antimalarials	6,150 (28.6)	3,567 (66.2)^a	2,879 (64.1)^a	3,846 (60.8)^a
NSAIDs	3,050 (14.2)	1,177 (21.8)^a	1,068 (23.8)^a	1,598 (25.3)^a
Immunosuppressants/biologics	1,343 (6.2)	2,489 (46.2)^a	2,374 (52.9)^a	3,315 (52.4)^a
Costs, mean (SD), USD
Total	7,520 (23,406)	13,668 (28,979)^a	18,992 (37,437)^a	22,761 (56,324)^a
Medical	6,242 (22,627)	10,662 (27,268)^a	15,195 (35,430)^a	17,828 (44,690)^a
Pharmacy	1,278 (4,466)	3,006 (7,044)^a	3,797 (8,758)^a	4,934 (22,355)^a
Disease severity, n (%)
Mildⁱ	17,208 (80.0)	1,724 (32.0)^a	777 (17.3)^a	475 (7.5)^a
Moderate^j	2,937 (13.6)	2,943 (54.6)^a	2,797 (62.3)^a	4,423 (69.9)^a
Severe^k	1,372 (6.4)	723 (13.4)^a	917 (20.4)^a	1,430 (22.6)^a
SLE flares
Patients with at least 1 SLE flare, n (%)	10,017 (46.6)	3,819 (70.9)^a	3,333 (74.2)^a	4,780 (75.5)^a
Number of any SLE flares per patient, mean (SD)	1.3 (0.6)	1.5 (0.7)^a	1.6 (0.8)^a	1.6 (0.8)^a
Patients with at least 1 mild SLE flare,^l n (%)	2,539 (11.8)	1,091 (20.2)^a	939 (20.9)^a	1,411 (22.3)^a
Number of mild SLE flares per patient, mean (SD)	1.1 (0.3)	1.1 (0.3)^c	1.1 (0.2)^c	1.1 (0.3)^c
Patients with at least 1 moderate SLE flare,^m n (%)	8,346 (38.8)	3,277 (60.8)^a	2,899 (64.6)^a	4,026 (63.6)^a
Number of moderate SLE flares per patient, mean (SD)	1.2 (0.4)	1.3 (0.5)^a	1.4 (0.6)^a	1.4 (0.5)^a
Patients with at least 1 severe SLE flare,ⁿ n (%)	357 (1.7)	225 (4.2)^a	314 (7.0)^a	615 (9.7)^a
Number of severe SLE flares per patient, mean (SD)	1.1 (0.4)	1.1 (0.4)^c	1.2 (0.5)^a	1.2 (0.5)^d
Patients with at least 1 moderate/severe SLE flare, n (%)	8,524 (39.6)	3,370 (62.5)^a	3,014 (67.1)^a	4,278 (67.6)^a
Number of moderate/severe SLE flares per patient, mean (SD)	1.2 (0.5)	1.4 (0.6)^a	1.4 (0.6)^a	1.4 (0.7)^a

^a P < 0.01 compared with the no OCS use cohort.

^b One patient with unknown sex was excluded from subsequent multivariate analysis.

^c P≥0.05 compared with the no OCS use cohort.

^d P < 0.05 compared with the no OCS use cohort.

^e Patients could have more than 1 value.

^f Primary care included general practitioner/family practitioner, nurse practitioner, and internal medicine physician.

^g Identified using the International Classification of Diseases, Ninth and Tenth Revisions, Clinical Modification codes.

^h Identified using Generic Product Identifier and Healthcare Common Procedure Coding System codes.

ⁱ Defined as eligible patients who did not meet the criteria for moderate or severe disease.

^j Defined as eligible patients who did not meet the criteria for severe disease and had either at least 1 nonlaboratory claim with a diagnosis of any moderate conditions, in any position, or had at least 1 filled prescription for an OCS with a prednisone-equivalent dose of at least 7.5 mg/day and less than 60 mg/day or for an immunosuppressive agent (other than cyclophosphamide) during the baseline period.

^k Defined as eligible patients who had at least 1 filled prescription for cyclophosphamide, rituximab, or OCS with a prednisone-equivalent dose of at least 60 mg/day during the baseline period, or those who had at least 1 nonlaboratory claim with a diagnosis of any severe conditions during the baseline period.

^l Defined as the initiation of an antimalarial drug, an OCS with prednisone-equivalent dose of no more than 7.5 mg/day, or a nonimmunosuppressant drug (ie, NSAIDS or androgens) during the baseline period. Treatment was considered to be initiated if there were no filled prescriptions for that class of medication in the 60 days prior to the medication fill. The length of flare for each episode was set to 30 days. However, if a flare of higher severity (moderate or severe) occurred during those 30 days, the length of the flare was limited to the time between the start of the mild flare and the start of the higher-severity flare.

^m Defined as the initiation of an OCS with a prednisone-equivalent dose of greater than 7.5 mg/day but no greater than 40 mg/day (if the patient had a prior fill within 60 days, treatment was considered initiated if the prior fill was for a prednisone-equivalent dose no more than 7.5 mg/day); an immunosuppressant drug (with the exception of cyclophosphamide); or a claim for an emergency department visit with a primary diagnosis of SLE with no inpatient admission within 1 day or a claim for an emergency department or office visit with a primary or secondary diagnosis for a specified SLE-related condition (if the diagnosis occurred during an office visit, the condition was required to be new, which was defined as no claims with this diagnosis during the previous 60 days) during the baseline period. The length of flare for each episode was set to 30 days; however, if a severe flare occurred during those 30 days, the length of the flare was limited to the time between the start of the moderate flare and the start of the severe flare.

ⁿ Defined as the initiation of an OCS with a prednisone-equivalent dose of greater than 40 mg/day (if the patient had a prior fill within 60 days, treatment was considered initiated if the prior fill was for a prednisone-equivalent dose of no more than 40 mg/day), cyclophosphamide (each prescription was counted as a new prescription if the prior fill was more than 100 days earlier), or admission for an inpatient hospital stay with a primary diagnosis of SLE or for a specified SLE-related condition during the baseline period. For flares based upon a hospitalization, the start date of the flare was the date that the patient was admitted to the hospital, unless the patient was admitted to the emergency department (with any diagnosis) during the previous day. If patients had an emergency department admission the day prior to the hospitalization, the date of the emergency department admission was considered to be the start date of the flare (note that only visits to an emergency department site were considered under this definition, and visits to urgent care or outpatient clinics were not included).

NSAID = nonsteroidal anti-inflammatory drug; OCS = oral corticosteroid; SLE = systemic lupus erythematosus; USD = US dollars; y = year.