Head-to-head Trials Open New Data in PsA With ‘Cautionary’ Interpretation
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MAUI, Hawaii — The past year was marked by an increase in head-to-head drug trials in psoriatic arthritis, according to a presentation at the 2020 Rheumatology Winter Clinical Symposium.
“A big change in psoriatic arthritis this year: head-to-head studies,” Arthur Kavanaugh, MD, professor of medicine at the University of California San Diego, told attendees. “We are starting to see much more of this. There are a ton in dermatology.”
In the SPIRIT-H2H trial, Mease and colleagues compared the IL-17 inhibitor ixekizumab (Taltz, Lilly) and the TNF inhibitor adalimumab (Humira, AbbVie) in 566 DMARD-naive patients. Kavanaugh presented findings for the co-primary endpoint of the proportion of patients in each group who simultaneously reached both PASI100 and ACR50 response. Results showed that 36% of 283 patients in the ixekizumab arm and 28% of 283 patients in the adalimumab arm reached this endpoint.
Looking at those outcome measures separately, 51% of patients in the ixekizumab arm and 47% of those in the adalimumab arm reached ACR50 response. PASI100 response was also superior in the ixekizumab arm, 60% vs. 47%. “You would think that ixekizumab would be better in the skin endpoint, but it beat [adalimumab],” Kavanaugh said. “Maybe more interesting is that if you look at all of the articular outcomes, they are overlapping.”
Shifting to the 483 patients who reached 52 weeks of analysis in SPIRIT-H2H, results indicated that ixekizumab bested adalimumab in both PASI100 and the joint endpoint of PASI100 and ACR50.
There was, however, a treatment interaction effect with methotrexate in this trial. Ixekizumab was superior to adalimumab in terms of ACR 20/50/70 response for patients treated with monotherapy, but when methotrexate was also used, adalimumab was slightly stronger. “We might also [learn] some differences about different mechanisms when we are giving these drugs with concomitant therapy,” Kavanaugh said.
“This study points out some of the cautionary notes about head-to-head studies and how you have to interpret them,” Eric M. Ruderman, MD, associate chief for clinical affairs of the division of rheumatology at Northwestern University Feinberg School of Medicine, added.
Ruderman also highlighted head-to-head findings from the EXCEED trial — presented for the first time at RWCS this year — in which McInnes and colleagues compared the IL-17 inhibitor secukinumab (Cosentyx, Novartis) with adalimumab in 853 patients. The analysis included 426 patients treated with secukinumab 300 mg and 427 treated with adalimumab 40 mg for 52 weeks.
Results showed that 67.4% of patients in the secukinumab arm reached the primary endpoint of ACR20 response, compared with 61.5% for adalimumab. “The superiority came close, but the P value was not quite .05,” Kavanaugh said.
Secondary outcome data showed that 65.4% of patients treated with secukinumab reached PASI90 response, while just 43.2% of those treated with adalimumab reached this endpoint. “The skin did better, and the resolution of enthesitis was good,” Kavanaugh said.
Safety data showed that fewer patients treated with secukinumab discontinued therapy due to adverse events, 14.3% vs. 23.7%.
“TNF [inhibitors] tend to be the first biologics we pull out for a patient with psoriatic arthritis,” Ruderman said. “But looking at these two studies, I do not know that that necessarily should be so. There is no reason why an IL-17 should not be an option in the first line.” – by Rob Volansky
Reference:
Kavanaugh A. Rheumatology 2019: Year in review. What’s new in Psoriatic Arthritis. Presented at RWCS Annual Meeting; Feb. 12-15, 2020; Maui, Hawaii.
Disclosure: Kavanaugh reports associations with AbbVie, Amgen, AstraZeneca, BMS, Celgene, Galapagos/Gilead, Genentech/Roche, Janssen, Novartis, Pfizer, Regeneron/Sanofi, UCB, ITN, LCTC, LIAI, NIH, TREG and CORONNA. Ruderman reports consultant relationships with Pfizer.
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