Background/Purpose: Tildrakizumab (TIL) is a high-affinity, anti–interleukin‐23p19 monoclonal antibody with demonstrated efficacy for the treatment of chronic plaque psoriasis in a phase 2b (P05495 [NCT01225731]) and 2 phase 3 clinical studies (reSURFACE 1 [NCT01722331] and 2 [NCT01729754]).^1,2 We evaluated hematological laboratory findings for evidence of drug-induced changes following TIL treatment using data from 3 randomized, placebo-controlled trials.

Methods: Data were pooled from the P05495 and reSURFACE 1 and 2 trials of patients with moderate to severe chronic plaque psoriasis. Here we report changes at week 52 vs baseline in hematological parameters for patients with continuous exposure to TIL 100 mg or 200 mg administered at week 0 and week 4, and every 12 weeks thereafter up to week 52 (P05495 and reSURFACE 2) or week 64 (reSURFACE 1). An analysis of changes in hematological parameters from baseline to worst values obtained relative to reference ranges is also reported.

Results: Among patients with continuous exposure to TIL 100 mg and 200 mg, limited changes in hematological parameters were observed. Mean (standard deviation) changes at week 52 vs baseline for TIL 100 mg (N = 249 patients with data) were 0.3% (2.4) for hematocrit, 0.1 g/dL (0.7) for hemoglobin, −4.0 x 10³/µL (37.0 x 10³) for platelets, 0.1 x 10³/µL (0.4 x 10³) for lymphocytes, 0 x 10⁶/µL (0.3 x 10⁶) for erythrocytes, and −0.5 x 10³/µL (1.6 x 10³) for neutrophils. Corresponding values for TIL 200 mg (N = 204 patients with data) were 0.3% (2.4) for hematocrit, 0.1 g/dL (0.8) for hemoglobin, −6.8 x 10³/µL (36.9 x 10³) for platelets, 0 x 10³/µL (0.5 x 10³) for lymphocytes, 0 x 10⁶/µL (0.2 x 10⁶) for erythrocytes, and −0.4 x 10³/µL (1.9 x 10³) for neutrophils. Similarly, limited changes were also seen for leukocytes, monocytes, eosinophils, lymphocytes/leukocytes, eosinophils/leukocytes, and basophils/leukocytes. The majority of patients (80.1%–100%) had hematological parameter values within normal ranges at baseline; worst values for most of these patients remained within normal ranges over 52 weeks. No changes correlated with adverse events such as infections or thrombocytopenia.

Conclusion: In this pooled analysis of phase 2b and phase 3 trials, only limited changes in hematological parameters—including white blood cells, erythrocytes, and platelets—were observed in patients treated with TIL over 52 weeks. Based on these data, patients receiving TIL are unlikely to require routine laboratory testing for hematological parameters.

Medical writing support was provided by Judy Phillips, DVM, PhD, of AlphaBioCom, LLC.

References:

1. Papp K, et al. Br J Dermatol. 2015;173:930−939.
2. Reich K, et al. Lancet. 2017;390:276–288.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/limited-changes-in-hematological-parameters-during-tildrakizumab-treatment-post-hoc-analysis-of-data-from-the-tildrakizumab-psoriasis-clinical-program/