Introduction
Risankizumab (RISA), an anti-interleukin (IL)-23p19 inhibitor, has demonstrated efficacy and safety in randomized controlled trials for the treatment of Crohn’s disease (CD).1,2 However, real world evidence assessing treatment persistence with RISA, particularly in the context of other advanced therapies (ATs) such as adalimumab (ADA, anti-TNF) is limited. Treatment persistence may serve as a surrogate for sustained clinical efficacy and tolerability in routine clinical practice.
Aims & Methods
A retrospective, observational cohort study aimed to assess patient characteristics and treatment persistence with RISA or ADA in adults with CD enrolled in the Canadian AbbVie Care Patient Support Program (PSP). Enrolled patients initiated RISA between January 2023 and December 2024, or ADA between January 2017 and December 2019 (censored at the end of 2020 to avoid impact of subsequent non-medical switch policies). While participation is voluntary, the PSP is estimated to capture >90% of patients in Canada receiving these therapies. 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 16,194 patients included in the analysis, 8,920 initiated RISA and 7,274 initiated ADA for CD. Among these, 28.2% and 75.4% were AT naïve, respectively. Patient characteristics are presented in Table 1. Median (range) follow-up duration was 12 (0-23) months for RISA and 20 (0-36) months for ADA. Among RISA patients, 6.3% received intravenous RISA rescue therapy and 2.3% received another form of dose adjustment during maintenance; whereas 41% of ADA patients received dose adjustment during maintenance. Overall, 6- and 12-month persistence was 0.92 (95% Confidence Interval: 0.92-0.93) and 0.83 (0.82-0.84) for RISA and 0.90 (0.90-0.91) and 0.80 (0.79-0.81) for ADA. Among AT naïve patients (2,514 on RISA and 5,484 on ADA), 6- and 12-month persistence was 0.94 (0.93-0.95) and 0.88 (0.86-0.89) for RISA and 0.91 (0.90-0.92) and 0.82 (0.81-0.83) 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
|
| Risankizumab
N=8,920
| Adalimumab
N=7,274
|
| Demographics |
|
|
Age in years, mean (SD)
Sex - Female, n (%)
Location, n (%)
- Rural
- Urban
- Unknown | 48.05 (16.67)
4,699 (52.7)
1,476 (16.5)
7,060 (79.1)
384 (4.3)
| 43.80 (15.59)
3,778 (51.9)
1,161 (16.0)
4,786 (65.8)
1,327 (18.2)
|
Clinical characteristics
|
|
|
Harvey Bradshaw Index, mean (SD); n
| 6.71 (5.13); 4,153
| 6.68 (5.16); 2,403
|
Treatment characteristics
|
|
|
AT naïve, n (%)
- Yes
- No
Number of prior ATs used, n (%)
- 0
- 1
- 2
- 3
- ≥4
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 |
2,514 (28.2)
6,406 (71.8)
2,514 (28.2)
2,694 (30.2)
2,115 (23.7)
1,044 (11.7)
553 (6.2)
202 (2.3)
8718 (97.7)
2,016 (22.6)
6,904 (77.4)
68 (3.4)
661 (32.8)
185 (9.2)
501 (24.9)
735 (36.5)
|
5,484 (75.4)
1,790 (24.6)
5,484 (75.4)
1,538 (21.1)
212 (2.9)
36 (0.5)
4 (0.1)
2,981 (41.0)
4,293 (59.0)
2,279 (31.3)
4,995 (68.7)
47 (2.1)
829 (36.4)
779 (34.2)
3 (0.1)
711 (31.2)
|
Conclusion
In these unadjusted analyses, CD patients receiving RISA in real-world practice demonstrated high treatment persistence, particularly among those who were AT naïve. Few RISA patients underwent dose adjustments during maintenance, and overall, treatment persistence was numerically higher than ADA treated patients. These observed findings may contribute to informing treatment decisions and improving patient care.
References
- D’Haens G, et al. Lancet. 2022;399:2015–30.
- Ferrante M, et al. Lancet. 2022;399:2031–46.
Disclosure
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.
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.
MH, S-JB, VD, JRO 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.
