Introduction
Upadacitinib (UPA), a Janus kinase inhibitor, has demonstrated efficacy and safety in randomized controlled trials for the treatment of moderate to severe ulcerative colitis (UC).1 However, real-world evidence on long-term durability remains limited, particularly in the context of other advanced therapies (ATs) including anti-TNFs, such as adalimumab (ADA). Treatment persistence may serve as a surrogate for sustained clinical outcomes and tolerability in routine clinical practice.
Aims & Methods
A retrospective, observational cohort study aimed to assess patient characteristics and treatment persistence with UPA or ADA in adults with UC enrolled in the Canadian AbbVie Care Patient Support Program (PSP). Patients who started UPA between January 2023 and December 2024, or ADA between January 2017 and December 2019, were included; ADA initiators were censored at the end of 2020 to avoid the impact of subsequent non-medical switch policies. While participation is voluntary, the PSP is estimated to capture >80% of UPA and >90% of ADA initiators in Canada. Data were collected from routine interactions with PSP personnel, including registered nurses; treatment and clinical management decisions remained at the discretion of prescribing physicians. Persistence over 12 months was estimated using Kaplan-Meier methods and defined as the duration from treatment initiation to discontinuation for any reason.
Results
Of 5,728 patients included in the analysis, 2,981 initiated UPA and 2,747 initiated ADA for UC. Among these, 24.4% and 68.6% were AT naïve, respectively. Patient characteristics are presented by treatment in Table 1. Median (range) follow-up duration was 12 (0-23) months for UPA and 16.5 (0-36) months for ADA. Overall, 6- and 12-month treatment persistence was 0.88 (95% Confidence Interval: 0.86-0.89) and 0.80 (0.78-0.81) for UPA and 0.79 (0.77-0.80) and 0.63 (0.62-0.65) for ADA. Among the subset of AT naïve patients (UPA n=728, ADA n=1,885), 6- and 12-month treatment persistence was 0.89 (0.86-0.91) and 0.81 (0.78-0.83) for UPA and 0.81 (0.79-0.82) and 0.66 (0.63-0.68) for ADA.
Table 1. Patient characteristics
|
|---|
| * Includes interval shortening/widening, dose escalation/de-escalation, or a combination of both dose and interval adjustments from the initial maintenance regimen; ** Multiple responses possible; ADA – adalimumab; UPA – upadacitinib; NA - Not Applicable |
| Upadacitinib
N=2,981
| Adalimumab
N=2,747
|
| Demographics |
|
|
Age in years, mean (SD)
Sex - Female, n (%)
Location, n (%)
- Rural
- Urban
- Unknown
| 43.46 (16.00)
1,255 (42.1)
414 (13.9)
2,454 (82.3)
113 (3.8)
| 44.00 (15.88)
1,280 (46.6)
399 (14.5)
1,850 (67.3)
498 (18.1)
|
Clinical characteristics
|
|
|
Full Mayo Score, mean (SD); n
Partial Adapted Mayo Score, mean (SD); n
| 8.28 (1.69); 162
2.96 (1.92); 966
| 4.10 (3.06); 71
2.20 (2.01); 432
|
Treatment characteristics
|
|
|
AT naïve, n (%)
- Yes
- No
Number of prior ATs used, n (%)
- 0
- 1
- 2
- 3
- ≥4
UPA - Initial maintenance dosing regimen, n (%)
- 15mg QD
- 30mg QD
- Other
- Unknown
ADA - Initial maintenance dosing regimen, n (%)
- 40mg Q2W
- Other
- Unknown
Any type of maintenance dose adjustments*, n (%)
- Yes
- No
Discontinued treatment, n (%)
- Yes
- No
Reason for discontinuation**, n (%)
- Death
- Efficacy
- Side effects
- Physician choice
- Other
|
728 (24.4)
2,253 (75.6)
728 (24.4)
940 (31.5)
727 (24.4)
369 (12.4)
217 (7.3)
723 (24.3)
2,129 (71.4)
39 (1.3)
90 (3.0)
NA
NA
NA
620 (20.8)
2,361 (79.2)
676 (22.7)
2,305 (77.3)
12 (1.8)
199 (29.4)
79 (11.7)
172 (25.4)
268 (39.6)
|
1,885 (68.6)
862 (31.4)
1,885 (68.6)
694 (25.3)
151 (5.5)
15 (0.5)
2 (0.1)
NA
NA
NA
NA
1,359 (49.5)
43 (1.5)
1,345 (49.0)
1,423 (51.8)
1,324 (48.2)
1,296 (47.2)
1,451 (52.8)
15 (1.2)
687 (53.0)
323 (24.9)
1 (0.1)
311 (24.0)
|
Conclusion
In these unadjusted analyses, UC patients receiving UPA demonstrated numerically higher persistence to ADA overall as well as in the subset of AT naïve patients. These observed findings may contribute to informing treatment decisions and supporting improved patient care.
References
1. Danese S, et al. Lancet. 2022;399:2113–28.
Disclosure
NN holds a McMaster University AFP Clinician Researcher Award and has received honoraria from Janssen, Abbvie, Takeda, Pfizer, Sandoz, Novartis, Iterative Health, Innomar Strategies, Fresenius Kabi, Amgen, Organon, Eli Lilly, and Ferring.
CS has participated in advisory boards and has been invited as a speaker by Janssen, Abbvie, Takeda, Lilly, Ferring, Merck, Pfizer, Organon, Sandoz, Pharmascience, Fresenius Kabi, Amgen, Celltrion, Sanofi, GSK, Biocon.
TB has received speaker, consultant and research support from Abbvie, Alimentiv, Bristol-Myers-Squibb, CSF Vifor, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Gilead, Iterative scope, Johnson and Johnson, Merck, Mirium, Pendopharm, Pentax, Pfizer, Roche, Sandoz, Sanofi, Takeda, Vial Pharma
MH, S-JB, VD, and GP are full-time employees of AbbVie and may own stock and options.
OH, MH and JD are full-time employees of ICON plc, which acted as a consultant to AbbVie on this study.
JKM has been a consultant to AbbVie, Alimentiv, Amgen, Avir Pharma, Bausch Health, Biocon, Bristol Myers Squibb, Celltrion, Ferring, Fresenius Kabi, GlaxoSmithKline, Janssen, Lilly, Merck, Organon, Pfizer, Pharmascience, Regeneron, Roche, Sandoz, Sanofi, Takeda, and has been invited as a speaker by AbbVie, Amgen, Bausch Health, Biocon, Ferring, Fresenius Kabi, Janssen, Lupin, Merck, Organon, Pfizer, Pharmascience, Roche, Takeda
