Session Type: Poster Session (Monday)
Session Time: 9:00AM-11:00AM
Background/Purpose: Tildrakizumab (TIL) is a high-affinity, anti–interleukin‐23p19 monoclonal antibody approved for the treatment of moderate-to-severe chronic plaque psoriasis. An inverse efficacy–body weight relationship has been reported for multiple fixed-dose systemic agents in patients with psoriasis, who tend to be of greater weight than the general population. We conducted a post hoc analysis of pooled data from 2 randomized, placebo (PBO)-controlled, phase 3 trials (reSURFACE 1 [NCT01722331] and 2 [NCT01729754]) to evaluate the impact of body weight on TIL efficacy in psoriasis.
Methods: In reSURFACE 1 and 2, patients were randomized to PBO or TIL 100 or 200 mg in Part 1 (Week [W] 0−12) and rerandomized in Parts 2 (W12−28) and 3 (W28−64 [reSURFACE 1] or W28−52 [reSURFACE 2]). Treatment was administered at W0, W4, and every 12 weeks thereafter. The median percentage improvement in Psoriasis Area and Severity Index (PASI) is reported for patients randomized to TIL 100 mg at baseline up to W52, or PBO up to W12. Data were stratified by weight decile, calculated separately for Parts 1 and 2 combined, and Part 3. A nonresponder imputation analysis was used.
Results: For Parts 1 and 2 (n=616), median weight (range) for the TIL 100-mg group at baseline was 86.3 kg (40.9−194.7 kg); median PASI was 17.9. For patients who entered Part 3 (n=329), median weight at baseline was 86.0 kg (47.0−194.7 kg); median PASI was 18.0. At W12, a slightly greater median percentage improvement in PASI was observed in the lower weight deciles: 87.4%, 86.6%, 83.6%, 88.9%, 81.5%, 84.3%, 83.1%, 78.0%, 76.7%, and 77.5% (lowest to highest decile). By W28, the difference in improvement between lowest and highest decile had narrowed: 91.6%, 91.9%, 92.6%, 90.4%, 91.1%, 90.6%, 91.2%, 87.7%, 87.0%, and 86.0%. At W52, efficacy was well maintained across all weight deciles: 100%, 96.9%, 96.9%, 96.6%, 96.6%, 97.2%, 95.3%, 93.4%, 93.5%, and 90.8%. For PBO (n=309), median weight at baseline was 85.7 kg (44.0−180.2 kg), and median PASI was 17.7. At W12, there was little improvement, with no distinct pattern, in PASI vs baseline (range: 1.2%–25.3%).
Conclusion: A modest weight-efficacy relationship with TIL 100-mg treatment was observed through W12, with more rapid efficacy in the lower weight deciles. Efficacy improved across deciles through W28, with a decreased difference between the lightest and heaviest deciles due to more rapid improvement in the latter. Efficacy responses in W28 PASI 75 responders were well-maintained, with >90% median PASI improvement across deciles at W52.
Editorial support was provided by Puneet Dang, PhD, of AlphaBioCom, LLC.
To cite this abstract in AMA style:Menter A, Draelos Z, Heim J, Parno J, Mendelsohn A, Rozzo S, Griffiths C. Impact of Body Weight on Efficacy of Tildrakizumab in Moderate-to-Severe Plaque Psoriasis [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/impact-of-body-weight-on-efficacy-of-tildrakizumab-in-moderate-to-severe-plaque-psoriasis/. Accessed February 19, 2020.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/impact-of-body-weight-on-efficacy-of-tildrakizumab-in-moderate-to-severe-plaque-psoriasis/