formerly of Eli Lilly and Company
Early clinical response as a predictor of subsequent response to ixekizumab treatment: results from a phase II study of patients with moderate-to-severe plaque psoriasis
Article first published online: 2 DEC 2013
© 2013 British Association of Dermatologists
British Journal of Dermatology
Volume 169, Issue 6, pages 1337–1341, December 2013
How to Cite
Zhu, B., Edson-Heredia, E., Cameron, G.S., Shen, W., Erickson, J., Shrom, D., Wang, P., Banerjee, S. and Gordon, K.B. (2013), Early clinical response as a predictor of subsequent response to ixekizumab treatment: results from a phase II study of patients with moderate-to-severe plaque psoriasis. British Journal of Dermatology, 169: 1337–1341. doi: 10.1111/bjd.12610
Funding sources Eli Lilly and Company.
Conflicts of interest B.Z., E.E.-H., G.S.C., W.S, J.E., D.S., P.W., and S.B. are all full-time employees of, and own stock in, Eli Lilly and Company. K.B.G. has received research support from Eli Lilly and Company, Amgen, Janssen Pharmaceuticals, Merck and Celgene Corporation, and honoraria from Eli Lilly and Company, Amgen, Pfizer, Janssen, Novartis, AbbVie and Celgene Corporation.
The primary results of this phase II study have previously been published (Leonardi C, Matheson R, Zachariae C, et al. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. N Engl J Med 2012; 366:1190–9).
- Issue published online: 2 DEC 2013
- Article first published online: 2 DEC 2013
- Accepted manuscript online: 6 SEP 2013 02:14AM EST
- Manuscript Accepted: 28 AUG 2013
- Jiaying Guo of inVentiv Health Clinical
Early identification of responsiveness to biologic treatments in psoriasis has significant clinical and economic implications.
To evaluate whether early clinical improvements in Psoriasis Area and Severity Index (PASI) scores could predict subsequent clinical responses in patients treated with ixekizumab, an anti-interleukin-17 monoclonal antibody.
This post hoc analysis was derived from a phase II study in patients with moderate-to-severe plaque psoriasis (n = 114) who received multiple doses of ixekizumab 10, 25, 75 or 150 mg subcutaneously over 20 weeks. PASI score improvements from baseline to weeks 2, 4 and 6 were evaluated to determine the optimal threshold for predicting subsequent PASI responses at week 12.
Early clinical improvement in disease symptoms at weeks 4 and 6 was predictive of ≥ 75% improvement in PASI score (PASI 75) at week 12 with ≥ 90% predictability. A 40–50% improvement in PASI (PASI 40 to PASI 50) from baseline to weeks 4 and 6 was the optimum range for predicting PASI 75 response at week 12. For all doses combined, achieving PASI 40 at week 4 or week 6 was associated with high negative predictive values (NPVs) (80% and 95%, respectively) and positive predictive values (PPVs) (89% and 84%, respectively). For all doses combined, achieving PASI 50 at week 4 or week 6 was associated with NPVs of 71% and 89% and PPVs of 94% and 89%, respectively. Sensitivity analysis with the high-dose group (75 and 150 mg) results confirmed these findings.
Early clinical responses (and nonresponse) may help predict later clinical responses in patients treated with ixekizumab.