Table 2.

Clinical trial results with IL-17 inhibitors in RA

Reference	Treatment	Patients	Main efficacy results
Hueber et al. (POC trial) [70, 71]	Secukinumab (10 mg/kg i.v. at baseline and week 3) vs placebo	n = 52 on stable MTX ≤ 25 mg/week	ACR20 at week 6 (1° endpoint): 46% vs 27% (P = 0.12) ACR20 at week 16: 54% vs 31% (P = 0.08) ACR20-AUC (P = 0.011), DAS28-AUC (P = 0.027) and CRP-AUC (P = 0.002) favoured secukinumab
Genovese et al. (phase 2) [72]	Secukinumab (25, 75, 150 or 300 mg s.c. monthly) vs placebo	n = 237 on stable MTX	ACR20 at week 16 (1° endpoint): 47–54% with doses of 75–300 mg vs 36% (P > 0.05) ACR responses maintained through week 52, reaching 90% in those treated with 150-mg dose
Genovese et al. (POC trial) [72, 73]	Ixekizumab (0.2, 0.6 or 2 mg/kg i.v. every 2 weeks for five doses) vs placebo	n = 77 on stable dose of ≥ 1 DMARDa	DAS28 change from baseline to week 10 (1° endpoint): −2.3, −2.2, and −2.4 vs −1.7 (P ≤ 0.05 except 0.6-mg/kg group) ACR20 at week 10: 74%, 70%, 90% vs 56% (P ≤ 0.05 for 2 mg/kg)
Genovese et al. (phase 2) [73]	Ixekizumab (3, 10, 30, 80 or 180b mg at baseline and weeks 1, 2, 4, 6, 8 and 10) vs placebo	n = 260 biologically naive patents and n = 188 TNF-IR patients on stable conventional DMARDs	Dose–response relationship based on ACR20 in biologically naïve patients at week 12 (1° endpoint): P = 0.031 ACR20 at week 12 in biologic-naive cohort: 45%, 43%, 70%, 51% and 54% vs 35% (P = 0.001 for 30-mg dose; others NS) ACR20 at week 12 in TNF-IR cohort: 40% and 39% vs 23% (both P ≤ 0.05)

ACR20: American College of Rheumatology 20% response rate; AUC: area under the response-vs-time curve; DAS28: 28-joint disease activity score; NS: not significant; POC: proof of concept; TNF-IR: TNF blocker inadequate responders. ^aMTX, HCQ, SSZ, LEF or AZA. ^bOnly the two highest doses were given to the TNF-IR cohort.