Arthritis Treatment Biologics Rheumatoid Arthritis Drugs in the Pipeline What Does the Future Hold for RA Treatment? By Lana Barhum Lana Barhum Verywell Health's Facebook Verywell Health's LinkedIn Lana Barhum has been a freelance medical writer for over 14 years. She shares advice on living well with chronic disease. Learn about our editorial process Updated on April 19, 2022 Medically reviewed by Riteesha G. Reddy, MD Medically reviewed by Riteesha G. Reddy, MD Riteesha G. Reddy, MD, is a board-certified rheumatologist and internist at a private practice in Dallas, Texas. Learn about our Medical Expert Board Print Table of Contents View All Table of Contents RA Drug Trends Peficitinib Plivensia Iberiotoxin ART-I02 ATI-450/CDD-450 The rheumatoid arthritis (RA) drug pipeline—what's currently in development by manufacturers—contains some promising new medications. They could help improve the outlook and quality of life for people with this debilitating disease. Drugs that have been in development include: PeficitinibPlivensiaIberiotoxinOthers too new to have names This article tracks their progress through the testing and approval phase. gorodenkoff / Getty Images When a drug is in development, it means that the manufacturer is testing its effectiveness and safety. This long, arduous process includes laboratory studies on microorganisms and animals, human trials, and, finally the Food and Drug Administration (FDA) approval process. RA Drug Trends The introduction of biologics in the late 1990s revolutionized the treatment of RA. Since then, researchers have uncovered a wealth of information about: Disease progressionSymptom improvementHow innovative future therapies could further improve life for people with RA This knowledge is propelling drug research forward. RA treatments have traditionally targeted inflammation pathways and responses. But now some researchers have shifted their focus to other elements, including immune system malfunction and the progression of the disease. What Is the Purpose of Clinical Trials? Peficitinib Peficitinib is an oral Janus kinase 1 (JAK-1) and JAK-3 inhibitor under investigation for rheumatoid arthritis. JAK inhibitors work by hindering the activity of one or more of the Janus kinase enzymes. Those are responsible for cell signaling that causes the inflammation and immune responses of RA. Thus far, it's approved for use as an RA drug in Japan and Korea, where it's marketed under the name Smyraf. Two phase 3 trials suggested this drug can improve outcomes in adults with moderate-to-severe RA who haven't respond well to the drug methotrexate and other therapies. Studies suggest peficitinib improves symptoms and suppresses joint destruction. Peficitinib is going through the FDA approval process. Its suggested use is as either a monotherapy (taken alone) or in combination with other disease-modifying anti-rheumatic drugs (DMARDs). Filgotinib In late 2019, Gilead Sciences, Inc., submitted a new drug application to the FDA for the selective JAK-1 inhibitor filgotinib. The FDA in 2020 rejected the application due to concerns over testicular toxicity. Filgotinib is approved for RA in Europe and Japan under the brand name Jyseleca. How JAK Inhibitors Work Plivensia Plivensia (sirukumab) is an injected interleukin-6 (IL-6) inhibitor. Interleukin-6 is a substance made by your immune system that is involved in inflammation. Drugs that inhibit it are believed to help reduce inflammation. In 2017, the FDA rejected the new drug application for Plivensia, citing an excess of deaths in people taking the drugs versus the control group. However, a 2018 RMD Open report says sirukumab's safety profile is much like that of any anti-IL agent. The FDA has yet to review this evidence. Phase III trials suggest it can significantly reduce RA symptoms and inhibit the progression of structural damage, and that it does so in people who didn't have success with DMARDs. If eventually approved, Plivensia would compete with two other IL-6 inhibitors currently on the market, Actemra (tocilizumab) and Kevzara (sarilumab). Iberiotoxin This unusual medication is based on scorpion venom. A 2018 study on rodents suggested components of scorpion venom may have the potential to reduce the severity of RA in animal models. In some cases, researchers say it even reversed joint damage. Moreover, this study shows iberiotoxin may have fewer side effects than other types of RA medications. Researchers suggest iberiotoxin could block the action of fibroblast-like synoviocytes (FLS), which they believe play a role in RA. They hypothesize that FLS may secrete damaging compounds into the joints that then attack immune cells, promoting joint inflammation and pain. Research into iberiotoxin for RA is in the earliest stages, so little is known about its safety or effectiveness. ART-I02 ART-I02 is being investigated by the biopharmaceutical company Athrogen. It's a gene therapy medication that may reduce interferon-beta (IFN-β), which produces proteins that promote the development of RA. Pre-clinical studies have found that one single injection of ART-I02 in animals is beneficial for managing the symptoms of RA and other types of arthritis, including osteoarthritis. Researchers are now looking at the effect ART-102 has on humans. ATI-450/CDD-450 This drug used to be designated CDD-450, but when Aclaris Therapeutics, Inc., acquired the company that was developing it, the designation changed to ATI-450. (Alpha-numeric designations are assigned before generic drug names.) It's classified as a selective p38-alpha MAPK inhibitor, which means that it blocks cellular communication that can lead to inflammation. A 2018 study reported in the Journal of Experimental Medicine finds ATI-450 can reduce the damage associated with RA. It's designed to halt inflammation in RA and other inflammatory autoimmune diseases. In early 2020, Aclaris announced positive results from its first phase I human trial and an intent to move on to phase II studies. This new drug is expected to have some advantages over biologics. Unlike biologics, it's available as a pill, so it doesn't need to be injected in the bloodstream. That makes it less expensive and easier to take. Also, the immune system sometimes rejects biologics. ATI-450 isn't expected to have the same negative effect on the immune system. Summary Drugs in the RA pipeline include JAK inhibitor peficitinib, interleukin-6 inhibitor Plivensia, scorpion venom-derivative iberiotoxin, interferon-beta drug ART-102, and selective p38-alpha MAPK inhibitor ATI-450. The JAK inhibitor filgotinib was rejected by the FDA and is no longer in development in the U.S. A Word From Verywell The current research on RA drugs in the pipeline is ongoing, with scientists all over the globe exploring new ways to prevent and diagnose RA and to deliver treatments that are effective and less costly. The hope is to help people living with RA achieve high-quality and pain-free lives. 10 Sources Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy. Qiu Q, Feng Q, Tan X, Guo M. JAK3-selective inhibitor peficitinib for the treatment of rheumatoid arthritis. Expert Rev Clin Pharmacol. 2019;12(6):547‐554. doi:10.1080/17512433.2019.1615443 Takeuchi T, Tanaka Y, Tanaka S, et al. Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase III randomised, double-blind, placebo-controlled trial (RAJ4) in Japan. Ann Rheum Dis. 2019;78(10):1305‐1319. doi:10.1136/annrheumdis-2019-215164 Healio News. Filgotinib drops out of US arthritis race: Gilead ends bid for FDA approval. Chowdhury, B. FDA Briefing Document. Arthritis Advisory Committee Meeting. Division Summary for the August 2, 2017 AAC meeting, biologics license application (BLA) 761057 for sirukumab injection for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease modifying antirheumatic drugs (DMARDs). August 2, 2017. Thorne C, Takeuchi T, Karpouzas GA, et al. Investigating sirukumab for rheumatoid arthritis: 2-year results from the phase III SIRROUND-D study. RMD Open 2018;4:e000731. doi:10.1136/rmdopen-2018-000731 Takeuchi T, Thorne C, Karpouzas G, et al. Sirukumab for rheumatoid arthritis: the phase III SIRROUND-D study. Ann Rheum Dis. 2017;76(12):2001‐2008. doi:10.1136/annrheumdis-2017-211328 Tanner MR, Pennington MW, Chamberlain BH, et al. Targeting KCa1.1 channels with a scorpion venom peptide for the therapy of rat models of rheumatoid arthritis. J Pharmacol Exp Ther. 2018;365(2):227-236. doi:10.1124/jpet.117.245118 Aalbers CJ, Bevaart L, Loiler S, et al. Preclinical potency and biodistribution studies of an AAV 5 vector expressing human interferon-β (ART-I02) for local treatment of patients with rheumatoid arthritis. PLoS ONE. 2015;10(6):e0130612. doi:10.1371/journal.pone.0130612 Clinicaltrials.gov. A single dose clinical trial to study the safety of ART-I02 in patients with arthritis. Wang C, Hockerman S, Jacobsen EJ, et al. Selective inhibition of the p38α MAPK-MK2 axis inhibits inflammatory cues including inflammasome priming signals. J Exp Med. 2018;215(5):1315-1325. doi:10.1084/jem.20172063 Additional Reading Arthritis Foundation. Rheumatoid arthritis treatment. Gelar J. Medical News Bulletin. New gene therapy drug for rheumatoid arthritis undergoes phase 1 trial. By Lana Barhum Lana Barhum has been a freelance medical writer since 2009. She shares advice on living well with chronic disease. See Our Editorial Process Meet Our Medical Expert Board Share Feedback Was this page helpful? Thanks for your feedback! What is your feedback? Other Helpful Report an Error Submit