Randomized, double-blind, crossover study of the adhesiveness of two formulations of rotigotine transdermal patch in patients with Parkinson's disease

Objective: In patch-based transdermal drug delivery, adhesiveness is critical for safe and effective treatment, especially in Parkinson's disease (PD) where excessive sweating is common. This study compared the adhesiveness of two transdermal patch formulations of rotigotine (improved room temperature-stable [PR2.3.1/Treatment A] and intermediate cold storage product [PR2.1.1/Treatment B]), using the largest patch size (40cm(2)).Methods: PD0018 (NCT02230904) was a multicenter, randomized, double-blind, crossover study. PD patients received Treatments A and B in randomized order for 2 days each. Patch adhesiveness was measured immediately after patch application and 24 hours thereafter (before removal). Primary variable: change in average investigator-rated adhesiveness score between treatments, per modified European Medicines Agency scale (EMA/CHMP/QWP/911254/2011, 2012).Results: Fifty-seven patients were randomized; 56 patients completed the study. Five patients were excluded from analysis for accidental unblinding. Treatment A had better average adhesiveness score (meanSD Treatment A - Treatment B: 1.115 +/- 1.635). A higher percentage of patients on both days had patch adhesiveness 95% at 24 hours for Treatment A (first day: 65.4%, second day: 71.2%) vs. Treatment B (46.2%, 36.5%), and were satisfied with patch adhesiveness of Treatment A (first day: 75.0%, second day: 73.1%) vs. Treatment B (65.4%, 59.6%). Average patch-wear duration was similar between formulations (23.761 hours vs. 23.495 hours per patch). Both formulations were well tolerated with no new safety observations.Conclusion: Results indicated greater adhesiveness for the improved room temperature-stable formulation (PR2.3.1) vs. intermediate cold storage product (PR2.1.1) using the largest patch-size, with comparable safety and skin tolerability

Minimal Impact of the COVID‐19 Pandemic on Disease Activity and Health‐Related Quality of Life in Patients With Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses From a Phase 2b Open‐Label Extension Study

Objective The impact of the COVID‐19 pandemic on patients with inflammatory rheumatic diseases, such as ankylosing spondylitis (AS), has been variable. Here, we assess disease activity and health‐related quality of life (HRQoL) through the pandemic in patients with AS. Methods In the open‐label extension (OLE) of the phase 2b BE AGILE study, patients with AS received 160 mg of subcutaneous bimekizumab every 4 weeks. We assessed Ankylosing Spondylitis Disease Activity Score with C‐reactive protein (ASDAS‐CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Quality of Life (ASQoL) scores in the OLE immediately before and during the COVID‐19 pandemic (September 2019 to April 2021). Results A total of 232 patients remained in the BE AGILE OLE and were included in this post hoc study at the start of the analysis period (September 1, 2019); 12 patients had a COVID‐19 treatment‐emergent adverse event, and no cases resulted in death. The number of missed bimekizumab doses due to COVID‐19 (11 doses) was minimal, and missed assessments remained low (≤5%) compared with the prepandemic period. Mean ASDAS‐CRP (1.8), BASDAI (2.4), and ASQoL scores (2.8) in the OLE were low at pre‐pandemic baseline and remained stable at 1.7 to 1.8, 2.2 to 2.4, and 2.0 to 2.8, respectively, across successive 3‐month periods immediately before and during the pandemic. ASDAS‐CRP, BASDAI, and ASQoL stability was consistent across major study countries. Conclusion Disease activity and HRQoL remained stable during the COVID‐19 pandemic in patients with AS receiving bimekizumab in the BE AGILE OLE, with no indication of negative effects on these outcomes

Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: Results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study

Objectives Bimekizumab selectively neutralises both interleukin (IL)-17A and IL-17F. We report efficacy and safety in a phase IIb dose-ranging study in patients with active ankylosing spondylitis (AS). Methods Adults with AS (fulfilling modified New York criteria) were randomised 1:1:1:1:1 to bimekizumab 16 mg, 64 mg, 160 mg, 320 mg or placebo every 4 weeks for 12 weeks (double-blind period). At week 12, patients receiving bimekizumab 16 mg, 64 mg or placebo were re-randomised 1:1 to bimekizumab 160 mg or 320 mg every 4 weeks to week 48; other patients continued on their initial dose (dose-blind period). The primary end point was Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 12 (non-responder imputation (NRI) for missing data). Results 303 patients were randomised: bimekizumab 16 mg (n=61), 64 mg (n=61), 160 mg (n=60), 320 mg (n=61) or placebo (n=60). At week 12, significantly more bimekizumab-treated patients achieved ASAS40 vs placebo (NRI: 29.5%-46.7% vs 13.3%; p<0.05 all comparisons; OR vs placebo 2.6-5.5 (95% CI 1.0 to 12.9)). A significant dose-response was observed (p<0.001). The primary end point was supported by all secondary efficacy outcomes. At week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 and 320 mg throughout the study achieved ASAS40, respectively (NRI); similar ASAS40 response rates were observed in re-randomised patients. During the double-blind period, treatment-emergent adverse events occurred in 26/60 (43.3%) patients receiving placebo and 92/243 (37.9%) receiving bimekizumab. Conclusions Bimekizumab provided rapid and sustained improvements in key outcome measures in patients with active AS, with no unexpected safety findings versus previous studies. Trial registration number NCT02963506

Bimekizumab Improves Key Patient Reported Symptoms of Axial Spondyloarthritis Including Spinal Pain and Fatigue: Results from Two Phase 3 Studies

Mease PJ, Deodhar A, Dougados M, et al. Bimekizumab Improves Key Patient Reported Symptoms of Axial Spondyloarthritis Including Spinal Pain and Fatigue: Results from Two Phase 3 Studies. In: American College of Rheumatolgy, ed. ABSTRACT SUPPLEMENT ACR Convergence 2022, November 10–14, 2022, Philadelphia, PA. Arthritis &amp; Rheumatology. Vol 74. Hoboken: Wiley; 2022: 810-813

Bimekizumab Improves Key Patient Reported Symptoms of Axial Spondyloarthritis Including Spinal Pain and Fatigue: Results from Two Phase 3 Studies

Bird P, Mease PJ, Deodhar A, et al. Bimekizumab Improves Key Patient Reported Symptoms of Axial Spondyloarthritis Including Spinal Pain and Fatigue: Results from Two Phase 3 Studies. Internal Medicine Journal. 2023;53(S2):24-25