Abstract
Background:
The incidence rate of uveitis in secukinumab-treated patients with axial spondyloarthritis (axSpA) was previously reported.
Objective:
To evaluate the incidence rate of uveitis in patients with axSpA and psoriatic arthritis (PsA) treated with secukinumab or placebo during placebo-controlled phase III studies.
Design:
This was a post hoc analysis from 11 phase III studies.
Methods:
Pooled data from axSpA (MEASURE 1–5 and PREVENT studies) and PsA (FUTURE 1–5 studies) were analyzed.
Results:
In the axSpA cohort (N = 1980), the incidence rate for uveitis was 1.29 per 100 patient-years in the secukinumab 150 mg and 1.72 per 100 patient-years in the placebo arm. In the PsA cohort (N = 2453), the incidence rate for uveitis was 0.71 per 100 patient-years in the secukinumab 300 mg arm; no events were reported in the placebo arm.
Conclusion:
During the placebo-controlled phase, a numerically lower incidence of uveitis was observed in secukinumab-treated axSpA patients. In PsA patients, the incidence was low in secukinumab-treated patients, while uveitis was not reported in the placebo group.
Keywords: axial spondyloarthritis, interleukin-17A, phase III study, psoriatic arthritis, uveitis
Introduction
Uveitis is one of the leading causes of visual impairment and blindness in patients.1,2 Acute anterior uveitis (AAU) is the most common extraarticular manifestation observed in patients with spondyloarthritis (SpA). 3 Association between human leukocyte antigen-B27 positivity and recurrent AAU has been reported in previous publications.3 –6 The prevalence of AAU is 23%–33% and 2%–25% in patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA), respectively.7 –9 A study reported that uveitis exposure-adjusted incidence rate (EAIR) may decrease with anti-tumor necrosis factor alpha (TNFα) monoclonal antibodies (mAbs) but may not decrease with etanercept and secukinumab. 10
Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A (IL-17A), is approved for the treatment of axSpA and PsA. The incidence rate of uveitis was previously reported as 1.4 per 100 patient-years in secukinumab-treated patients with axSpA in pooled phase III trials over 4 years of treatment. 4 Moreover, uveitis incidences were reported in long-term observational studies, however, without any control group. In the current study, we analyzed pooled data during the comparative placebo-controlled phase from large pivotal studies. The objective of this post hoc analysis was to assess the incidence rate of uveitis in a large pool of patients with axSpA and PsA treated with subcutaneous (s.c.) secukinumab or placebo in placebo-controlled phases.
Methods
Study design and patients
In this post hoc analysis, data were included from 11 phase III axSpA and PsA studies: PREVENT 11 and MEASURE 1–5 (axSpA),12 –15 and FUTURE 1–5 (PsA).16 –20 The study designs and eligibility criteria of the PREVENT, MEASURE 1–5, and FUTURE 1–5 studies have been previously published.11 –20 The analysis included all patients with axSpA and PsA who received either 150 or 300 mg of s.c. secukinumab treatment or placebo. The comparative phase (placebo-controlled phase) was up to Week 16 for MEASURE 1–5 and FUTURE 1–5 studies. In the case of the PREVENT study, the selected time period was up to Week 20. This specific timepoint was chosen to ensure that all patients were on the randomized double-blind treatment.
Assessments
Data on demographics, relevant (current) medical conditions, prior use of a number of TNFα inhibitors, and concomitant treatment and doses were collected for patients (axSpA and PsA cohorts) at baseline. Analysis of uveitis was based on adverse events reported, using the MedDRA preferred term “Uveitis.” The diagnosis of uveitis was confirmed by ophthalmologists. The incidence of uveitis was reported as EAIR per 100 patient-years of secukinumab or placebo treatment. EAIR per 100 patient-years is defined as the number of uveitis patients divided by the exposure time on secukinumab or placebo treatment (but expressed per 100 patient-treatment years). Incidences are presented by subcategories: new-onset uveitis and flares of uveitis in patients without and with a pre-existing history of uveitis, respectively.
Results
The current analysis included 1980 and 2453 patients in the axSpA and PsA cohorts, respectively. Females represented 35% and 52% of the study population in the axSpA and PsA cohorts, respectively. Compared to the axSpA cohort (14%), the percentage of patients with a history of uveitis was lower (0.4%) in the PsA cohort.
In the axSpA and PsA cohorts, 79% and 70% of patients, respectively, were naïve to TNFα inhibitors. Twenty-one percent of patients with axSpA received sulfasalazine (19% in secukinumab 150 mg, 26% in secukinumab 300 mg, and 22% in placebo), whereas 52% of patients with PsA received concomitant methotrexate (52% in secukinumab 150 mg, 50% in secukinumab 300 mg, and 53% in placebo; Table 1).
Table 1.
Baseline characteristics of patients with axSpA and PsA by secukinumab dose and placebo.
| Characteristics a | axSpA | PsA | ||||
|---|---|---|---|---|---|---|
| SEC 150 mg (N = 1177) | SEC 300 mg (N = 76) |
Placebo (N = 727) |
SEC 150 mg (N = 1109) | SEC 300 mg (N = 461) |
Placebo (N = 883) |
|
| Age, years | 39.4 (11.6) | 42.1 (11.8) | 40.1 (12.3) | 48.9 (12.0) | 48.6 (12.8) | 49.1 (12.0) |
| Female (%) | 422 (35.9) | 26 (34.2) | 248 (34.1) | 568 (51.2) | 235 (51.0) | 483 (54.7) |
| Weight, kg | 77.1 (18.0) | 82.7 (16.9) | 76.9 (16.2) | 85.3 (20.2) | 84.2 (18.1) | 82.9 (19.5) |
| Time since first diagnosis, years | 5.2 (6.9) | 5.3 (7.3) | 5.7 (7.5) | 6.8 (7.6) | 7.3 (8.4) | 6.9 (7.6) |
| Relevant medical history or current medical condition, n (%) | ||||||
| Uveitis | 153 (13.0) | 15 (19.7) | 109 (15.0) | 7 (0.6) | 2 (0.4) | 2 (0.2) |
| HLA-B27 (positive) b | 893 (75.9) | 56 (73.7) | 550 (75.7) | – | – | – |
| Current smoker | 341 (29.0) | 24 (31.6) | 228 (31.4) | 242 (21.8) | 90 (19.5) | 172 (19.5) |
| Methotrexate use at BL | 108 (9.2) | 13 (17.1) | 73 (10.0) | 573 (51.7) | 228 (49.5) | 466 (52.8) |
| Sulfasalazine use at BL | 227 (19.3) | 20 (26.3) | 163 (22.4) | 2 (0.2) | 3 (0.7) | 7 (0.8) |
| Corticosteroid use at BL | 96 (8.2) | 7 (9.2) | 73 (10.0) | 179 (16.1) | 66 (14.3) | 129 (14.6) |
| Mean dose at baseline, mean (SD) | ||||||
| Methotrexate, mg/week | 14.6 (9.9) | 16.4 (4.4) | 17.5 (18.6) | 15.5 (5.2) | 16.3 (9.8) | 15.8 (6.2) |
| Sulfasalazine, mg/week | 1.8 (0.6) | 2.0 (0.7) | 1.8 (0.7) | 1.3 (0.4) | 2.0 (0.0) | 1.83 (0.3) |
| Corticosteroid, mg/week | 6.4 (2.8) | 8.7 (2.9) | 27.3 (159.9) | 6.5 (2.5) | 6.9 (3.8) | 6.8 (3.8) |
| Number of prior TNFα inhibitors, n (%) | ||||||
| 0 | 932 (79.2) | 57 (75.0) | 568 (78.1) | 784 (70.7) | 316 (68.5) | 619 (70.1) |
| 1 | 238 (20.2) | 19 (25.0) | 158 (21.7) | 203 (18.3) | 80 (17.4) | 148 (16.8) |
| ⩾2 | 7 (0.6) | 0 (0.0) | 1 (0.1) | 122 (11.0) | 65 (14.1) | 116 (13.1) |
Variables given as mean (SD) unless specified otherwise.
HLA-B27 data were not collected in the PsA cohort.
axSpA, axial spondyloarthritis; BL, baseline; HLA-B27, human leukocyte antigen-B27; PsA, psoriatic arthritis; SD, standard deviation; SEC, secukinumab; TNF, tumor necrosis factor.
In the axSpA cohort, the incidence rate for uveitis was 1.29 per 100 patient-years in the secukinumab 150 mg arm (five patients with uveitis (three with flares and two with new-onset)) and 1.72 per 100 patient-years in the placebo arm (four patients with uveitis (three with flares and one with new-onset)). No cases were observed in the secukinumab 300 mg arm (Table 2). In the PsA cohort, the incidence rate for uveitis was 0.71 per 100 patient-years in the secukinumab 300 mg arm (one patient with new-onset); no events were reported in the secukinumab 150 mg and placebo arms. Flares were not reported in the PsA cohort. The severity of reported events in both axSpA and PsA was mild to moderate, with no event leading to treatment discontinuation.
Table 2.
Exposure-adjusted incidence rate of uveitis during placebo and secukinumab comparative phase in patients with axSpA and PsA.
| Type of uveitis n/EX, IR (95% CI) |
axSpA | PsA | ||||
|---|---|---|---|---|---|---|
| SEC 150 mg (N = 1177) |
SEC 300 mg (N = 76) |
Placebo (N = 727) |
SEC 150 mg (N = 1109) |
SEC 300 mg (N = 461) |
Placebo (N = 883) |
|
| Flares | 3/388.3, 0.77 (0.16, 2.26) |
0/23.3, 0.00 (0.00, 15.85) |
3/232.2, 1.29 (0.27, 3.78) |
– | – | – |
| New onset | 2/388.4, 0.51 (0.06, 1.86) |
0/23.3, 0.00 (0.00, 15.85) |
1/232.9, 0.43 (0.01, 2.39) |
0/341.2, 0.00 (0.00, 1.08) |
1/141.1, 0.71 (0.02, 3.95) |
0/266.5, 0.00 (0.00, 1.38) |
| Total | 5/387.8, 1.29 (0.42, 3.01) |
0/23.3, 0.00 (0.00, 15.85) |
4/232.2, 1.72 (0.47, 4.41) |
0/341.2, 0.00 (0.00, 1.08) |
1/141.1, 0.71 (0.02, 3.95) |
0/266.5, 0.00 (0.00, 1.38) |
axSpA, axial spondyloarthritis; CI, confidence interval; EX, exposure in patient-years; IR, incidence rate per 100 patient-years; n, number of patients with an event; PsA, psoriatic arthritis; SEC, secukinumab.
Discussion
The current post hoc pooled analysis reports the incidence of uveitis in patients with axSpA and PsA treated with secukinumab or placebo during placebo-controlled phases. In patients with axSpA, the incidence of uveitis was found to be numerically lower in those treated with secukinumab than in those who received a placebo. The low incidence rate for uveitis (1.29 per 100 patient-years) in the secukinumab-treated axSpA cohort is consistent with the findings from an earlier pooled analysis of the three phase III clinical trials in secukinumab-treated patients with ankylosing spondylitis (AS), which reported a rate of 1.4 per 100 patient-years. 4 This is consistent with a separate study, which reported an incidence rate of 1.69 per 100 patient-years of uveitis with secukinumab in axSpA and 3.47 per 100 patient-years with ixekizumab. 7 The annual incidence of uveitis was 1.06% with anti-TNF mAbs. Furthermore, according to this published report, the incidence of uveitis was significantly lower with anti-TNF mAb in comparison to anti-IL-17A (odds ratio: 0.34; 95% confidence interval (0.12, 0.92)). 7 In a large network meta-analysis of randomized controlled trials, the crude annual incidence of AU was 1.06%, 2.14%, 2.11%, and 3.10% in the anti-TNF mAb, ETN, anti-IL-17A, and placebo groups, respectively. The history of anterior uveitis was less frequent in the etanercept and anti-IL-17A groups compared with the anti-TNF group. 7 Earlier, three randomized controlled trials did not show any benefits with s.c. secukinumab in treating uveitis; however, a study conducted with intravenous secukinumab revealed an advantage in the treatment of uveitis. 21 Results of the current study are consistent with the real-world data where the number of new cases of onset of uveitis in patients with AS and PsA under secukinumab treatment were low; specifically, among the patients with AS, only 1 out of 626 patients experienced uveitis onset, while among the patients with PsA, the occurrence was 2 out of 1195 patients experiencing uveitis onset. 22
The current study revealed a relatively low incidence rate of uveitis (1.72 per 100 patient-years) in patients with axSpA who were treated with a placebo. This finding is in contrast with the results of other studies that were not related to secukinumab, which reported higher incidence rates of uveitis (10.3 per 100 patient-years 23 and 15.6 per 100 patient-years 24 ) in patients with axSpA or AS who received the placebo treatment. Moreover, the incidence rates of uveitis, which were seen in secukinumab and placebo-treated patients, are lower than expected from the earlier published reports.7,25 In the present study, the EAIR of uveitis in patients with axSpA treated with secukinumab was slightly lower when compared to patients treated with another IL-17A inhibitor, bimekizumab, in a different study. The EAIR of uveitis in the present study was 1.29 per 100 patient-years with secukinumab, while the study with bimekizumab reported an EAIR of 1.8 per 100 patient-years in patients with axSpA. 26 The incidences of uveitis reported in studies with IL-17 inhibitors are presented in Supplemental Table S1. The axSpA patient pool in the current analysis comprised both radiographic and non-radiographic axial spondyloarthritis (nr-axSpA) patients. The reason for this was the small percentage of patients with nr-axSpA, accounting for only 28% (555 out of 1982) of the total axSpA patient population pooled from the PREVENT study. A total of 555 patients with nr-axSpA were randomized in the PREVENT study, with 369 receiving secukinumab and 186 receiving a placebo. 11 The results revealed that the incidence rate of uveitis up to 20 weeks was 0.5% for both secukinumab and placebo. The EAIRs of uveitis were 1.2 and 1.8 per 100 patient-years for secukinumab and placebo, respectively, over a minimum exposure period of 52 weeks. The current study adds valuable data to other studies in the literature that incorporated a placebo control,24,26 enhancing our understanding of uveitis incidence in patients with axSpA and PsA.
The main limitation of the current study was the presentation of data from a pooled clinical trial database, wherein the clinical trials were conducted as per study protocols and do not reflect real-world clinical experience. To present the placebo and secukinumab data side-by-side, this report considered only the relatively short placebo-controlled phase at the beginning of the studies for both treatments. The results may be influenced by concomitant treatments with sulfasalazine and methotrexate, though the effectiveness of both these drugs on uveitis is limited.27,28 Since most participants (~80%) in the study were biologic-naïve, any formal comparison of uveitis incidence between biologic-naïve and biologic-resistant patients (~20%) was limited. The results of the post hoc analysis are exploratory in nature and should be interpreted with caution. Further investigations in clinical and real-world settings are warranted.
Conclusion
During the placebo-controlled phase, a numerically lower incidence of uveitis was observed in secukinumab-treated axSpA patients. In PsA patients, the incidence was low in secukinumab-treated patients, while uveitis was not reported in the placebo group.
Supplemental Material
Supplemental material, sj-docx-1-tab-10.1177_1759720X251340255 for Uveitis in patients with axial spondyloarthritis or psoriatic arthritis: a post hoc analysis from placebo-controlled phase III studies with secukinumab by Jan Brandt-Jürgens, Martin Rudwaleit, Frank Behrens, Christopher Ritchlin, Daniel Peterlik, Erhard Quebe-Fehling and Atul Deodhar in Therapeutic Advances in Musculoskeletal Disease
Supplemental material, sj-docx-2-tab-10.1177_1759720X251340255 for Uveitis in patients with axial spondyloarthritis or psoriatic arthritis: a post hoc analysis from placebo-controlled phase III studies with secukinumab by Jan Brandt-Jürgens, Martin Rudwaleit, Frank Behrens, Christopher Ritchlin, Daniel Peterlik, Erhard Quebe-Fehling and Atul Deodhar in Therapeutic Advances in Musculoskeletal Disease
Acknowledgments
We thank the patients who participated in the study and the study investigators for their contributions. We thank Rajeeb Ghosh (Novartis Healthcare Pvt Ltd) for providing medical writing support and John Gallagher (Novartis Pharma AG) for providing review support and guidance in accordance with Good Publication Practice (GPP 2022) guidelines.
Footnotes
Supplemental material: Supplemental material for this article is available online.
Contributor Information
Jan Brandt-Jürgens, Rheumatologische Schwerpunktpraxis, Bundesallee 104/105, 12161 Berlin, Germany.
Martin Rudwaleit, Internal Medicine and Rheumatology, Klinikum Bielefeld Rosenhöhe, University of Bielefeld, Bielefeld, Germany.
Frank Behrens, Rheumatology University Hospital and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Goethe University, Frankfurt, Germany.
Christopher Ritchlin, Allergy, Immunology and Rheumatology Division, University of Rochester Medical Center, Rochester, NY, USA.
Daniel Peterlik, Novartis Pharma GmbH, Nürnberg, Germany.
Erhard Quebe-Fehling, Novartis Pharma AG, Basel, Switzerland.
Atul Deodhar, Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, USA.
Declarations
Ethics approval and consent to participate: The studies were conducted according to the guidelines for Good Clinical Practice and were approved by the ethical committees. Details about the independent ethics committees or institutional review boards that approved the studies are provided in Supplemental Table S1. Written informed consent was obtained from all patients before enrollment.
Consent for publication: Not applicable.
Author contributions: Jan Brandt-Jürgens: Conceptualization; Data curation; Investigation; Writing – review & editing.
Martin Rudwaleit: Conceptualization; Data curation; Investigation; Writing – review & editing.
Frank Behrens: Conceptualization; Data curation; Investigation; Writing – review & editing.
Christopher Ritchlin: Conceptualization; Data curation; Investigation; Writing – review & editing.
Daniel Peterlik: Conceptualization; Data curation; Investigation; Methodology; Writing – review & editing.
Erhard Quebe-Fehling: Conceptualization; Data curation; Formal analysis; Methodology; Writing – review & editing.
Atul Deodhar: Conceptualization; Data curation; Investigation; Writing – review & editing.
Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was sponsored by Novartis Pharma AG, Basel, Switzerland.
J.B.-J.: received consulting fees and honoraria for lectures, and from serving on speaker’s bureaus and participating in educational events from AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen, Medac, Gilead, Affibody, Sun Pharma, Galapagos, Fresenius, and AlphaSigma. M.R.: received speaking and/or consulting fees from AbbVie, Boehringer-Ingelheim, Eli-Lilly, Janssen, Novartis, and UCB. F.B.: received consulting fees and honoraria for lectures, and from serving on speaker’s bureaus and participating in educational events from Janssen Cilag, Sandoz, Novartis, Amgen, Lilly, UCB, Pfizer, BMS, Boehringer, AbbVie, Acelyrin, MoonLake, and GSK. Received support from UCB and AbbVie for attending meetings. C.R.: received consulting fees from Abbie, UCB, Novartis, Janssen, BMS, Moon Lake, Solaris, Lilly and research support from Novartis, Janssen, and BMS. D.P.: Employee of Novartis. E.Q.-F.: Retired employee of Novartis; was an employee of Novartis until the final draft of the manuscript; owns stocks of Novartis. A.D.: Consulting, Advisory Boards: Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, UCB. Research Grants: Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, and UCB.
Availability of data and materials: The datasets generated during and analyzed during this study are not publicly available. Novartis is committed to sharing with qualified external researchers access to patient-level data and supporting clinical documents from eligible studies. The requests are reviewed and approved on the basis of scientific merit. All data provided are anonymized to respect the privacy of patients who have participated in the trial, in line with applicable laws and regulations. The data can be requested from the corresponding author of the manuscript.
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Associated Data
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Supplementary Materials
Supplemental material, sj-docx-1-tab-10.1177_1759720X251340255 for Uveitis in patients with axial spondyloarthritis or psoriatic arthritis: a post hoc analysis from placebo-controlled phase III studies with secukinumab by Jan Brandt-Jürgens, Martin Rudwaleit, Frank Behrens, Christopher Ritchlin, Daniel Peterlik, Erhard Quebe-Fehling and Atul Deodhar in Therapeutic Advances in Musculoskeletal Disease
Supplemental material, sj-docx-2-tab-10.1177_1759720X251340255 for Uveitis in patients with axial spondyloarthritis or psoriatic arthritis: a post hoc analysis from placebo-controlled phase III studies with secukinumab by Jan Brandt-Jürgens, Martin Rudwaleit, Frank Behrens, Christopher Ritchlin, Daniel Peterlik, Erhard Quebe-Fehling and Atul Deodhar in Therapeutic Advances in Musculoskeletal Disease