SELECT-COMPARE supports safety of JAK, TNF inhibitor switching in RA
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MAUI, Hawaii — Findings from the SELECT-COMPARE trial demonstrated that patients with rheumatoid arthritis may safely switch between a TNF inhibitor and a JAK inhibitor, or vice versa, in the case of non-response, according to presenters at the 2020 Rheumatology Winter Clinical Symposium.
“We are going to discuss what is good, what is bad, and what is ugly [about new molecules],” Roy M. Fleischmann, MD, of the University of Texas Southwestern Medical Center, told attendees.
Fleischmann was accompanied by Mark C. Genovese, MD, James W. Raitt professor of medicine and clinical chief of the division of immunology and rheumatology at Stanford University, who outlined the SELECT-COMPARE trial.
The study investigated treatment switching between adalimumab (Humira, Abbvie) and upadacitinib (Rinvoq, Abbvie) in 1,629 patients with moderate-to-severe rheumatoid arthritis who failed to respond to methotrexate.
The 48-week, randomized, double-blinded, placebo-controlled trial included 651 patients initially assigned upadacitinib, 651 assigned placebo and 327 assigned adalimumab. “This was a really large trial,” Genovese said. “Keep in mind, these patients all had background methotrexate.”
Study protocols called for patients in the placebo arm to be switched to upadacitinib 15 mg plus methotrexate, while those initially assigned upadacitinib were switched to adalimumab 40 mg plus methotrexate and those initially assigned adalimumab were switched to upadacitinib 15 mg plus methotrexate.
In addition, patients could be rescued at 14, 18 or 22 weeks if they failed to show a response to their initial assigned therapy. Results indicated that 19% of patients in the upadacitinib arm failed to demonstrate a response and were switched to adalimumab, while 24% of those in the adalimumab arm were switched to upadacitinib.
“If they did not reach a CDAI score of 10 by week 26, they were then rescued to ensure that these patients were getting to a treat-to-target design,” Genovese said.
For Genovese, there was one key take-home message to consider in this trial. “This was one of the first trials that enabled us to better understand what happens if you have been on a JAK inhibitor, and did not achieve an adequate response, what would happen if you then received a TNF inhibitor,” he said.
Fleischmann highlighted the safety outcomes, which showed that regardless of which way patients switched — from JAK to TNF or vice versa — there was no new safety signal. “These patients switched the next day,” he said. “There is no reason [for concern], because you can do it safely.” – by Rob Volansky
Reference:
Fleischmann R, Genovese M. New molecules. Presented at RWCS Annual Meeting; Feb. 12-15, 2020; Maui, Hawaii.
Disclosure: Fleischmann reports consulting and/or speaking fees from AbbVie, Asahi Kasei Medical, Astellas Pharma, AstraZeneca, Bristol-Myers-Squibb, Celltrion Healthcare, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Eisai, Janssen, Merck Serono, Mitsubishi Tanabe Pharma, Nippon Kayaku, Novartis Pharma, Pfizer Japan, Takeda Pharmaceutical, and UCB Japan. Genovese reports associations with Abbvie, Amgen, BeiGene, EMD, Galapagos, Genentech/Roche, Gilead, GSK, Lilly, Pfizer, Principia Bio, Regeneron, R-Pharm, Sandoz/Novartis, Sanofi, UCB and Unity Biotechnology.