Drug Updates

Tofacitinib, an oral janus kinsase inhibitor for the treatment of rheumatoid arthritis (RA), has received an approval recommendation from the FDA Arthritis Advisory Committee.¹³ The committee voted eight to two in favor of approving tofacitinib for adults with moderate-to-severe active RA in those who have not had an adequate response to one or more DMARDs. The agent had overwhelmingly positive efficacy information according to the committee, which was demonstrated in five phase III clinical trials with statistically significant increases seen on ACR 20, 50, and 70 responses. Radiographic outcomes were less clear. Safety discussions were raised related to the incidence of serious infections, which included pneumonia and skin and soft tissue infections.

Twelve cases of tuberculosis and 19 cases of herpes zoster were also reported. Additionally, malignancy was reported in 66 patients treated with tofacitinib, while the cancer rates increased over the study duration. From baseline to Month 6, cancer rates were 0.79 per 100 patient-years, and at Month 24, they were 1.43 per 100 patient-years. Seven tofacitinib-treated patients developed lymphoma; none of the placebo-treated patients did. Infections and malignancies seemed to be dose related (at 10 mg); a 5 mg dose was also studied.

Drug News

In another study presented at the British Society of Rheumatology meeting, tocilizumab monotherapy or combined with MTX in patients with at least moderate disease activity led to significant and very early suppression of RA disease activity and damage in a large cohort of patients (n=556).¹⁴ The relative risk of achieving remission at Month 6 was 40% among those patients that received tocilizumab plus MTX, compared with 35% for patients that received tocilizumab monotherapy (P=0.19). In a substudy following three months of treatment, preerosive changes detectable on MRI were reversed from baseline, with significant changes in synovitis scores. As early as two weeks following treatment, inflammatory changes were already seen on MRI. Most study participants were women, with a mean age of 53 years and mean RA duration of eight years. This study suggests that tocilizumab could be used as monotherapy in patients unwilling or unable to take MTX.

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Whitaker M, Guo J, Kehoe T, Benson G. Bisphosphonates for osteoporosis—Where do we go from here? N Engl J Med. 2012. DOI 10.1056/NEJMP1202619.
2. Gever J. Plavix generic competitors get green light. Published May 17, 2012. Available at www.medpagetoday.com/Cardiology/Prevention/32758. Accessed May 25, 2012.
3. Will D. Elite Pharmaceuticals announces first shipment of generic hydromorphone product. Published March 13, 2012. Available at www.elitepharma.com/investor_relations.asp?goto=342. Accessed May 25, 2012.
4. Phillips P. Covidien’s Mallinckrodt business launches morphine sulfate oral solution in U.S. Published March 22, 2012. Available at http://investor.covidien.com/phoenix.zhtml?c=207592&p=irol-newsArticle&ID=1675292&highlight=. Accessed May 25, 2012.
5. Akrimax to launch Suprenza ODT. Published April 10, 2012. Available at www.empr.com/akrimax-to-launch-suprenza-odt/article/235824/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed May 25, 2012.
6. sNDAs submitted for Xarelto for treatment and prevention of recurrent venous thromboembolism. Published May 2, 2012. Available at www.empr.com/sndas-submitted-for-xarelto-for-treatment-and-prevention-of-recurrent-venous-thromboembolism/article/239285/. Accessed May 7, 2012.
7. Walker EP. FDA panel narrowly rejects Xarelto for ACS. Published May 23, 2012. Available at www.medpagetoday.com/Cardiology/AcuteCoronarySyndrome/32888. Accessed May 25, 2012.
8. Han DH. Peripheral opioid receptor antagonist CB-5945 improves bowel motility. Published May 19, 2012. Available at www.empr.com/peripheral-opioid-receptor-antagonist-cb-5945-improves-bowel-motility/article/241906/. Accessed May 21, 2012.
9. Walsh N. Novel biologic targets lupus. Published May 2, 2012. Available at www.medpagetoday.com/MeetingCoverage/BSR/32462?utm_source=WC&utm_medium=email&utm_campaign=Meeting_Roundup_BSR. Accessed May 11, 2012.
10. NDA submitted for Zohydro for treatment of chronic pain. Published May 2, 2012. Available at www.empr.com/nda-submitted-for-zohydro-for-treatment-of-chronic-pain/article/239283/. Accessed May 7, 2012.
11. Dane L. FDA panel backs Arena, Eisai’s Lorqess. Published May 10, 2012. Available at www.firstwordpharma.com/node/982229. Accessed May 25, 2012.
12. Walsh N. IL-17 blocker promising for spondylitis. Published May 1, 2012. Available at www.medpagetoday.com/Rheumatology/BSR/32449. Accessed May 7, 2012.
13. Walsh N, Agus ZS. Pfizer’s arthritis pill gets nod from FDA panel. Published May 9, 2012. Available at www.medpagetoday.com/Rheumatology/Arthritis/32594. Accessed May 10, 2012.
14. Walsh N. Biologic works as monotherapy in early RA. Published May 3, 2012. Available at www.medpagetoday.com/MeetingCoverage/BSR/32500?utm_source=WC&utm_medium=email&utm_campaign=Meeting_Roundup_BSR. Accessed May 11, 2012.