Introduction
Conventional therapy is recommended for the treatment of mild-to-moderate ulcerative colitis (UC); however, patients (pts) are often unable to maintain durable responses and may be suboptimally treated with the overuse of corticosteroids (CS). Some studies on advanced therapies have reported pts achieving CS-free remission, which may benefit pts with UC. This study characterizes CS overuse and the associated economic burden.
Aims & Methods
Data were extracted from the IBM MarketScan Commercial and Medicare Supplemental Databases (January 1, 2014–March 31, 2021) for pts (age ≥18 years) with ≥2 UC diagnoses (≥90 days apart) who received first-line (1L) conventional therapy and had continuous enrollment for 6 months before and 4 years after treatment initiation, respectively. Conventional therapy included aminosalicylates (5-ASA), immunomodulators (IM), CS monotherapy, and CS combination therapy. CS overuse was identified if pts had an episode of receiving CS for a continuous period of >90 days or ≥2 episodes within 1 year. For pts with CS overuse, the index date was defined as the earlier of the 91st day of a CS episode or the initiation date of the second CS episode within 1 year. For pts without CS overuse, the index date was defined as 12 months after the initiation of 1L conventional therapy. All-cause healthcare resource use (HCRU) and costs incurred in terms of per pt per year (PPPY) were evaluated for pts with and without CS overuse at baseline (6 months before the index date) and during the follow-up period (from the index date to the end of 4 years after initiation of 1L).
Results
Overall, 4004 pts were included. Of these, 1820 (45.5%) pts had CS overuse. Median time from 1L treatment initiation to CS overuse was 9.4 (interquartile range, 4.5–23.0) months. Pts with CS overuse were less likely to receive mesalamine monotherapy in 1L (28.1% vs 56.7%) (Table). For pts with and without CS overuse, the baseline mean PPPY medical costs were $15,942 and $5964 (P<0.001), and total mean drug costs were $6051 and $6970, respectively (P<0.001). During the follow-up period, pts with CS overuse had higher inpatient (24.6% vs 14.2%; P<0.001) and emergency room visits (59.0% vs 50.5%; P<0.001) than those without; for pts with and without CS overuse, total mean medical costs were $10,418 and $4922 (P<0.001), and total mean drug costs were $9951 and $5923 (P<0.001), respectively.
Table. Pt characteristics and treatment use
| | Pts with CS overuse
(N=1820) | Pts without CS overuse
(N=2184) |
| Age, mean ± standard deviation, years | 47.7 ± 13.1 | 46.4 ± 12.5 |
| Female, n (%) | 1040 (57.1) | 1171 (53.6) |
| Conventional therapies received in 1L, n (%) |
| Mesalamine | 511 (28.1) | 1239 (56.7) |
| CS | 780 (42.9) | 393 (18.0) |
| CS + mesalamine | 359 (19.7) | 244 (11.2) |
| IM | 10 (0.5) | 36 (1.6) |
| IM + mesalamine | 4 (0.2) | 22 (1.0) |
| Other regimensa | 156 (8.6) | 250 (11.4) |
aBalsalazide monotherapy, olsalazine monotherapy, and combinations of CS, IM, and 5-ASA.
Conclusion
Approximately half of pts with UC had overused CS while being treated with conventional therapies. In these pts, all-cause HCRU during follow-up, and costs at baseline (except for drug costs) and during follow-up were significantly higher compared with those without CS overuse, suggesting a need for other more effective therapies to be considered for the treatment of these pts. Pts with UC currently treated with prolonged CS courses may benefit from early use of advanced therapies, which are associated with the induction of CS-free remission.
Disclosure
SNH received consulting fees from AbbVie, Bristol Myers Squibb, Janssen, and Takeda. DP is an employee and shareholder of Bristol Myers Squibb. KAB, XN, and SG are employees of the Analysis Group, which received funding for the current research from Bristol Myers Squibb.