Tofacitinib is not a biologic
نویسنده
چکیده
As the Global Medical Affairs Gastroenterology Lead for tofacitinib at Pfizer, I read with great interest the review by Dr Ungar and Dr Kopylov entitled “Advances in the development of new biologics in inflammatory bowel disease (IBD)” [1]. In reading the article, I identified a number of inaccuracies concerning tofacitinib, which I thought should be brought to the attention of the authors and your readers. Throughout the article tofacitinib is described as being a “biologic”. Although it may be appropriate to compare the efficacy and safety of tofacitinib to the existing biologic therapies used in IBD, tofacitinib is a synthetic small molecule JAK inhibitor and not a biologic agent. Tofacitinib was introduced along with descriptions of the biologics, including anti-integrins and ustekinumab. It would be more accurate if tofacitinib was split from these biologic agents and instead described in a separate sentence, since antiintegrins and ustekinumab are biologics and tofacitinib is not. In relation to safety events, in place of the current “The adverse effect profile for tofacitinib appears to be similar to other biologics...”, it would be more accurate to state that “The adverse effect profile for tofacitinib appears to be similar to that of biologics...”, thus separating tofacitinib from the biologic drug class. With respect to the discussion around immunogenicity and tofacitinib, because tofacitinib is a synthetic small molecule JAK inhibitor and not a biologic agent we would not expect there to be any immunogenicity. Hence, no specific studies of the immunogenicity of tofacitinib have been performed or are planned at present. Finally, we are nearing completion of a phase 3 development program of tofacitinib in ulcerative colitis [2,3] and we look forward to sharing the results of these studies with the gastroenterological community in the future.
منابع مشابه
Tofacitinib for the treatment of tumor necrosis factor-α inhibitor refractory esophageal Crohn’s disease: a case report
BACKGROUND Esophageal Crohn's disease is reported as a rare manifestation, although its prevalence may be underestimated because upper endoscopies are not routinely performed in asymptomatic adults. Tofacitinib, an oral janus kinase inhibitor, is a new biologic that has shown promise in the treatment of ulcerative colitis and may be effective in the treatment of Crohn's disease according to pha...
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Objective This study was designed to directly compare the outcomes of tofacitinib therapy for methotrexate-refractory rheumatoid arthritis (RA) between biologic-naïve patients and patients who had experienced an inadequate response to biological agents. Methods We prospectively enrolled and followed 113 patients who had a high or moderate clinical disease activity index (CDAI) (36 biologic-naïv...
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Systematic review and meta-analysis of serious infections with tofacitinib and biologic disease-modifying antirheumatic drug treatment in rheumatoid arthritis clinical trials
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Since the introduction of immune modulators in the treatment of rheumatoid arthritis (RA), there has been hope that orally effective biologic agents would be developed. Tofacitinib, a Janus kinase inhibitor, has become the first oral biologic to receive approval for use in active RA patients. This paper reviews the efficacy and safety profile of Tofacitinib at dosages of 5 mg and 10 mg twice da...
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عنوان ژورنال:
دوره 30 شماره
صفحات -
تاریخ انتشار 2017