Study design
Adapted from Harris JE, et al. 2023.2
The efficacy of Opzelura® monotherapy has been studied over the long-term2,3
TRuE-V was a Phase 3 long-term extension (LTE) roll-over study from TRuE-V1 & TRuE-V2 which evaluated the long-term efficacy & safety of Opzelura® (ruxolitinib) twice daily for a further 52 weeks. This double-blind, vehicle-controlled, randomised, withdrawal and treatment-extension study enrolled 458 eligible patients with vitiligo who had completed either of the parent studies (TRuE-V1 and TRuE-V2; Week 52); patients were assigned to either cohort A or B with a follow-up of 104 weeks.1–3
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Study design of TRuE-V LTE: Supporting context
In TRuE-V1 and TRuE-V2, Opzelura® cream was statistically superior to vehicle at Week 24 across the primary (29.8% [66/211] vs 7.4% [8/109]; P<0.001) and all key secondary endpoints, with continued improvement in outcomes through Week 52.4
The TRuE-V LTE study assessed the time to relapse (defined as achieving <F-VASI75) in adolescents and adults with non-segmental vitiligo who had achieved near-complete facial repigmentation (F-VASI90) during the TRuE-V parent studies and were subsequently randomised to vehicle (Opzelura® withdrawal; Cohort A).2 The study also evaluated for how long patients maintained F-VASI90 responses when treated with vehicle or Opzelura® (Cohort B).3
The TRuE-V LTE study assessed the long-term maintenance of repigmentation and time to relapse in participants with non-segmental vitiligo who achieved significant facial repigmentation in the TRuE-V1 and TRuE-V2 studies2,3
Cohort A study endpoints2
- Primary efficacy endpoint:
- Time to relapse, defined as <F-VASI75
- Safety and tolerability were also assessed
Cohort B study endpoints3
- Efficacy endpoints:
- Percentage of patients applying Opzelura® from Day 1 or switching from vehicle to Opzelura® at Week 24 of the TRuE-V studies who did not achieve almost complete facial repigmentation at Week 52, achieving the following outcomes at Week 104:
- F-VASI75
- F-VASI90
- T-VASI50
- Safety and tolerability were also assessed
Baseline demographics and clinical characteristics were similar between treatment groups in both cohorts2,3
Patient demographics Cohort A (≥F-VASI90 at Week 52)2
| Vehicle cream (n=58)† | Opzelura® (n=58)† | |
| Age, median (IQR), y | 40.0 (32.0–47.0) | 44.0 (35.0–55.0) |
| Female, n (%) | 31 (53.4) | 33 (56.9) |
| White, n (%) | 42 (72.4) | 48 (82.8) |
| Fitzpatrick skin type, n (%) | ||
| I–III | 33 (56.9) | 39 (67.2) |
| IV–VI | 25 (43.1) | 19 (32.8) |
| Baseline F-VASI, mean±SD | 0.87 (0.49) | 0.99 (0.64) |
| Baseline T-VASI, mean±SD | 6.13 (2.10) | 6.30 (2.02) |
| F-BSA,‡ mean±SD | 0.92 (0.49) | 1.09 (0.74) |
| T-BSA, mean±SD | 6.84 (2.18) | 6.86 (1.91) |
| Duration of disease, median (IQR), y | 11.6 (3.2–19.3) | 9.7 (4.3–17.4) |
| Received diagnosis in childhood, n (%) | 16 (27.6) | 15 (25.9) |
| Disease stability,§ n (%) | ||
| Stable | 42 (72.4) | 40 (69.0) |
| Progressive | 16 (27.6) | 18 (31.0) |
| Other autoimmune disorders, n (%) | 12 (20.7) | 10 (17.2) |
| Previous therapy,¶ n (%) | 43 (74.1) | 40 (69.0) |
| Topical calcineurin inhibitor | 26 (44.8) | 22 (37.9) |
| Topical corticosteroid | 21 (36.2) | 17 (29.3) |
| Phototherapy** | 24 (41.4) | 20 (34.5) |
Adapted from Harris JE, et al. 2023.2
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Patient demographics Cohort B (<F-VASI90 at Week 52)3
| Opzelura® From Day 1 (n=224) | Vehicle to Opzelura® (n=118) | |
| Age, median (IQR), y | 39.0 (26.0–51.0) | 39.0 (30.0–49.0) |
| Female, n (%) | 129 (57.6) | 61 (51.7) |
| White, n (%) | 180 (80.4) | 107 (90.7) |
| Fitzpatrick skin type, n (%) | ||
| I–III | 163 (72.8) | 97 (82.2) |
| IV–VI | 61 (27.2) | 21 (17.8) |
| Baseline F-VASI, mean±SD | 0.91 (0.55) | 0.88 (0.54) |
| Baseline T-VASI, mean±SD | 6.73 (2.02) | 6.70 (2.15) |
| F-BSA,‡ mean±SD | 1.02 (0.64) | 1.01 (0.63) |
| T-BSA, mean±SD | 7.50 (2.00) | 7.42 (2.06) |
| Duration of disease, median (IQR), y | 11.7 (5.2–21.7) | 13.6 (6.8–23.4) |
| Received diagnosis in childhood, n (%) | 86 (38.4) | 43 (36.4) |
| Disease stability,§ n (%) | ||
| Stable | 167 (74.6) | 91 (77.1) |
| Progressive | 57 (25.4) | 27 (22.9) |
| Other autoimmune disorders, n (%) | 42 (18.8) | 26 (22.0) |
| Previous therapy,¶ n (%) | 138 (61.6) | 69 (58.5) |
| Topical calcineurin inhibitor | 79 (35.3) | 38 (32.2) |
| Topical corticosteroid | 72 (32.1) | 24 (20.3) |
| Phototherapy** | 70 (31.3) | 37 (31.4) |
Adapted from Rosmarin D, et al. 2023.3
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Opzelura® is contraindicated during pregnancy and breastfeeding.1
*Patients randomised to vehicle who relapsed (i.e., <F-VASI75) could apply Opzelura® BID rescue treatment for the remainder of the LTE period.2
†One patient from the vehicle arm and 2 patients from the Opzelura® arm were incorrectly assigned to this cohort and were not included in the efficacy analyses. Two other patients (1 in each arm) were also excluded from the efficacy analyses.2
‡Percentage of T-BSA.2,3
§Determination of disease stability was based on investigator judgment.2,3
¶Patients could have used multiple previous lines of therapy.2,3
**Phototherapy includes NB-UVB phototherapy, excimer laser, PUVA photochemotherapy, and other phototherapy.2,3
Abbreviations
BID, twice daily; BSA, body surface area; F-BSA, facial body surface area; F-VASI, Facial Vitiligo Area Scoring Index; F-VASI75, ≥75% reduction from baseline in Facial Vitiligo Area Scoring Index; F-VASI90, ≥90% reduction from baseline in Facial Vitiligo Area Scoring Index; IQR, interquartile range; LTE; long-term extension; NB-UVB, narrow-band ultraviolet-B; PUVA, psoralen ultraviolet-A; SD, standard deviation; T-BSA, total body surface area; TRuE-V, topical ruxolitinib evaluation in vitiligo study; T-VASI, Total Vitiligo Area Scoring Index.
References
- Opzelura® (ruxolitinib) cream Summary of Product Characteristics. Incyte Biosciences UK Ltd.
- Harris JE, et al. American Academy of Dermatology (AAD) Annual Meeting, March 17–21, 2023. Oral presentation.
- Rosmarin D, et al. American Academy of Dermatology (AAD) Annual Meeting, March 17–21, 2023. Oral presentation.
- Rosmarin D, et al. N Engl J Med. 2022;387:1445–1455.
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