{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T07:44:57Z","timestamp":1792395897277,"version":"4.4.0"},"reference-count":44,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2020,9,7]],"date-time":"2020-09-07T00:00:00Z","timestamp":1599436800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the efficacy and safety of PF\u201006651600 (ritlecitinib), an irreversible inhibitor of JAK3 and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family, in comparison with placebo in patients with rheumatoid arthritis (RA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>An 8\u2010week, phase II, double\u2010blind, parallel\u2010group study was conducted. Seventy patients who were seropositive for anti\u2013citrullinated protein antibodies and\/or rheumatoid factor were randomized 3:2 to receive oral PF\u201006651600 (200 mg once daily) or placebo for 8 weeks. Eligible patients had an inadequate response to methotrexate, and the study design allowed up to 50% of patients to have previously received 1 tumor necrosis factor inhibitor that was inadequately effective and\/or not tolerated. The primary end point was change from baseline in the Simplified Disease Activity Index (SDAI) score at week 8, assessed by Bayesian analysis using an informative prior distribution for placebo response.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Mean change from baseline in the SDAI score at week 8 was greater in the PF\u201006651600 group (\u221226.1 [95% credible interval \u221229.7, \u221222.4]) than in the placebo group (\u221216.8 [95% credible interval \u221220.9, \u221212.7]; <jats:italic>P<\/jats:italic> &lt; 0.001). Most adverse events (AEs) were mild in severity, and no treatment\u2010related serious AEs, severe AEs, or deaths were reported. The most common classes of AE were infections and infestations as well as skin and subcutaneous tissue disorders; there was 1 mild case of herpes simplex in the PF\u201006651600 group that was considered to be treatment related, which resolved within 3 days without study treatment discontinuation or antiviral therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Treatment with the oral JAK3\/TEC inhibitor PF\u201006651600 (200 mg once daily) was associated with significant improvements in RA disease activity and was generally well\u2010tolerated in this small 8\u2010week study.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.41316","type":"journal-article","created":{"date-parts":[[2020,5,18]],"date-time":"2020-05-18T03:08:51Z","timestamp":1589771331000},"page":"1621-1631","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":81,"title":["Efficacy and Safety of PF\u201006651600 (Ritlecitinib), a Novel JAK3\/TEC Inhibitor, in Patients With Moderate\u2010to\u2010Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate"],"prefix":"10.1002","volume":"72","author":[{"given":"Michael F.","family":"Robinson","sequence":"first","affiliation":[{"name":"California Medical Research Associates  Northridge"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nemanja","family":"Damjanov","sequence":"additional","affiliation":[{"name":"University of Belgrade School of Medicine  Belgrade Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bojana","family":"Stamenkovic","sequence":"additional","affiliation":[{"name":"Institute for Treatment and Rehabilitation Niska Banja and Nis University School of Medicine  Nis Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Goran","family":"Radunovic","sequence":"additional","affiliation":[{"name":"University of Belgrade School of Medicine  Belgrade Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan","family":"Kivitz","sequence":"additional","affiliation":[{"name":"Altoona Center for Clinical Research  Duncansville Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lori","family":"Cox","sequence":"additional","affiliation":[{"name":"Pfizer, Inc.  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zorayr","family":"Manukyan","sequence":"additional","affiliation":[{"name":"Pfizer, Inc.  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Banfield","sequence":"additional","affiliation":[{"name":"Pfizer, Inc.  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Saunders","sequence":"additional","affiliation":[{"name":"Pfizer, Inc.  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deepa","family":"Chandra","sequence":"additional","affiliation":[{"name":"Pfizer, Inc.  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael S.","family":"Vincent","sequence":"additional","affiliation":[{"name":"Pfizer, Inc.  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Mancuso","sequence":"additional","affiliation":[{"name":"Pfizer, Inc.  Groton Connecticut"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Peeva","sequence":"additional","affiliation":[{"name":"Pfizer, Inc.  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean S.","family":"Beebe","sequence":"additional","affiliation":[{"name":"Pfizer, Inc.  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,9,7]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204627"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2011.204"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-207524"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.39480"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)60826-4"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar1969"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40744-015-0016-9"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-7843.2009.00375.x"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.23794"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.30129"},{"key":"e_1_2_8_12_1","first-page":"318","article-title":"The mechanism of action of tofacitinib: an oral janus kinase inhibitor for the treatment of rheumatoid arthritis","volume":"34","author":"Hodge JA","year":"2016","journal-title":"Clin Exp Rheumatol"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.0902819"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1507247"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1608345"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1186\/s41927-018-0031-x"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31115-2"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.41032"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.1201348"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210104"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.9055"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bmc.2018.08.005"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.39955"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-215163"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1021\/acschembio.6b00677"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1021\/acschembio.9b00188"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1101\/cshperspect.a002287"},{"key":"e_1_2_8_28_1","first-page":"67","article-title":"BTK signaling in B cell differentiation and autoimmunity","volume":"393","author":"Corneth OB","year":"2016","journal-title":"Curr Top Microbiol Immunol"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-202576"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.27584"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1111\/1756-185X.12901"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1517\/14712598.3.2.351"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2016.12.005"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjx003"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.38949"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208901"},{"key":"e_1_2_8_37_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.39473"},{"key":"e_1_2_8_38_1","doi-asserted-by":"publisher","DOI":"10.1021\/jm401490p"},{"key":"e_1_2_8_39_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.5b00301"},{"key":"e_1_2_8_40_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208279"},{"key":"e_1_2_8_41_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.13745"},{"key":"e_1_2_8_42_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.39808"},{"key":"e_1_2_8_43_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.20303"},{"key":"e_1_2_8_44_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)60453-5"},{"key":"e_1_2_8_45_1","doi-asserted-by":"publisher","DOI":"10.1111\/ejh.13148"}],"container-title":["Arthritis &amp; Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fart.41316","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.41316","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/art.41316","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.41316","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T11:31:35Z","timestamp":1759923095000},"score":1,"resource":{"primary":{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/10.1002\/art.41316"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,9,7]]},"references-count":44,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2020,10]]}},"alternative-id":["10.1002\/art.41316"],"URL":"https:\/\/doi.org\/10.1002\/art.41316","archive":["Portico"],"relation":{},"ISSN":["2326-5191","2326-5205"],"issn-type":[{"value":"2326-5191","type":"print"},{"value":"2326-5205","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,9,7]]},"assertion":[{"value":"2019-06-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-05-13","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-09-07","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}