Decernotinib, Subcutaneous Methotrexate Drug Updates, Trials, Approvals

Following a median exposure of 2.4 years, serious adverse drug events (SAEs) in tofacitinib-treated patients with RA have remained stable and have not increased.⁶ In a safety analysis presented at the Annual European Congress of Rheumatology (EULAR 2014) in June, 5,671 patients representing 12,644 patient-years of tofacitinib exposure showed stable AE rates with no new risks identified compared to prior reports. Patients were included from Phases 2 and 3 and open-label extension clinical trials. Patients received tofacitinib for at least 48 months (n=555), 36 months (n=1,948), 24 months (n=3,804) and 12 months (n=4,204), with 16.3% (n=926) discontinuing treatment due to AEs. Infections, including disseminated and multidermatomal herpes zoster, were the most serious AEs (SAEs). Nonmelanoma skin cancer (NMSC) rates were low at 0.85% per 100 patient-years, and lymphoma and lymphoproliferative disorder rates were similar across the time intervals. Cancer rates (excluding NMSC) were comparable to U.S. Surveillance, Epidemiology and End Results Program (SEER) rates from cohorts of RA patients who were treated with tumor necrosis factor inhibitors. Non-serious and serious herpes zoster infections occurred at a rate of 4.22 (95% CI, 3.87, 4.61).

In July, the Drug Enforcement Agency rescheduled tramadol and its salts and isomers into the controlled substance category IV (C-IV) under the Controlled Substances Act.⁷ Beginning Aug. 18, 2014, the C-IV designation was mandated of drug manufacturers to be placed on any tramadol-containing products. The scheduling of tramadol was based on a review of existing data, including concern regarding its addictive, abusive and diversion potential. Thirteen states, including New York, Mississippi and Arkansas, had already placed tramadol into C-IV.⁸

Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. van Vollenhoven R, Genovese MC, Zhang Y, et al. A phase 2b, 24-week study of VX-509 (decernotinib), an oral selective Janus kinase 3 inhibitor, in combination with background methotrexate in rheumatoid arthritis. Ann Rheum Dis. 2014;73(Suppl2); Abstract OP0151. http://www.abstracts2view.com/eular/view.php?nu=EULAR14L_OP0151.
2. Medac Pharma, Inc secures FDA approval of Rasuvo (methotrexate injection for rheumatoid arthritis, poly-articular-course juvenile idiopathic arthritis and psoriasis. Press release. Medac Pharma, Inc. July 14, 2014. http://www.marketwatch.com/story/medac-pharma-inc-secures-fda-approval-of-rasuvo-methotrexate-injection-for-rheumatoid-arthritis-poly-articular-course-juvenile-idiopathic-arthritis-and-psoriasis-2014-07-14.
3. FDA approves Rasuvo injection for RA, JIA, and psoriasis. MPR. July 14, 2014. http://www.empr.com/fda-approves-rasuvo-injection-for-ra-jia-psoriasis/article/360643.
4. FDA approves new extended-release oxycodone with abuse-deterrent properties. FDA news release. July 23, 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm406407.htm.
5. FDA withdraws approval of some high dose acetaminophen products. NABP Compliance News. July 2014; 3. http://www.nabp.net/system/rich/rich_files/rich_files/000/000/444/original/3qnatnews2014.pdf.
6. Cohen S, Tanaka Y, Mariette X, et al. Integrated safety analysis of tofacitinib in RA clinical trials with a cumulative exposure of 12,664 patient-years. Ann Rheum Dis. 2014;73(Suppl2):Abstract OP0154. http://www.abstracts2view.com/eular/view.php?nu=EULAR14L_OP0154.
7. 21 CFR Part 1308 [Docket No. DEA–351]. Schedules of controlled substances: Placement of tramadol into schedule IV. Federal Register. 2014 July 2;79(127):27623–27630. http://www.gpo.gov/fdsys/pkg/FR-2014-07-02/pdf/2014-15548.pdf.
8. Blank C. Tramadol moves to Schedule IV classification. Drug Topics: Voice of the Pharmacist. July 11, 2014. http://drugtopics.modernmedicine.com/drug-topics/news/tramadol-moves-schedule-iv-classification.