The safety of upadacitinib is still being evaluated. The treatment is also in Phase 3 trials for psoriatic arthritis and is being investigated to treat Crohn’s disease, ulcerative colitis and atopic dermatitis.
Abatacept Prefilled Syringes Now Available
On June 8, the FDA announced the availability of a new subcutaneous abatacept (Orencia) dosing option for patients at least two years old with moderate to severe active polyarticular juvenile idiopathic arthritis (JIA).5 Now available in a prefilled syringe, this new dosage form offers patients, caregivers, physicians and other healthcare providers the ability to administer abatacept at home.
The safety experience and immunogenicity for subcutaneously administered abatacept in Study JIA-2 were consistent with the intravenous Study JIA-1, with no reported cases of hypersensitivity reactions. The incidence of local injection-site reactions was 4.4%.
Generic 2% Diclofenac Sodium Now Available
A 2% diclofenac sodium topical solution is now available in a generic form to treat knee osteoarthritis.6 The treatment was originally approved by the U.S. Food and Drug Administration (FDA) in 2014 under the brand name Pennsaid from Horizon Pharmaceuticals.7
Post-Teriparatide Denosumab for Osteoporosis
After 18–24 months, the sequential treatment of osteoporosis with denosumab promoted significantly greater bone mineral density (BMD) increases compared with bisphosphonates in women with severe postmenopausal osteoporosis who had stopped teriparatide treatment. This result comes from a retrospective, observational study presented at the 19th European Congress of Endocrinology in Lisbon, Portugal.8
During the study, 140 women from a clinic in Slovenia used bisphosphonates (i.e., alendronate, risedronate, ibandronate or zoledronic acid) with denosumab (n=70) or without denosumab (n=70) after receiving teriparatide treatment. All patients received 1,000 IU vitamin D3 daily, with instructions to take 1,200 mg calcium daily. Lumbar spine BMD, total hip BMD and femoral neck BMD were measured via DXA when teriparatide was stopped and after 12 months of denosumab treatment. Lower BMD increases were noted for bisphosphonate-only-treated patients compared with denosumab-treated patients in femoral neck and lumbar spine BMDs. A trend toward a lower rate of new fractures with denosumab compared with bisphosphonates (5.7% vs. 17.1%, respectively) was also noted.9 Initially, around 90% of patients had prevalent vertebral fractures. The patients also had similar baseline clinical characteristics, except that total hip BMD was greater for denosumab-treated patients compared with bisphosphonate-treated patients (0.739 g/cm3 vs. 0.694 g/cm3, respectively).
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- U.S. Food and Drug Administration. FDA News Release: FDA requests removal of Opana ER for risks related to abuse. 2017 Jun 8..
- Endo International Plc. News release: Endo provides update on Opana ER. PR Newswire. 2017 Jul 6.
- AbbVie Inc. News release: AbbVie’s upadacitinib (ABT-494) meets all primary and ranked secondary endpoints in phase 3 study in rheumatoid arthritis. PR Newswire. 2017 Jun 7.
- U.S. National Institutes of Health. A study comparing ABT-494 to placebo in subjects with rheumatoid arthritis on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) who have an inadequate response to csDMARDs alone (SELECT-NEXT). ClincalTrials.gov. 2017 Jun 29.
- Bristol-Myers Squibb Co. News release: Bristol-Myers Squibb announces availability of new Orencia (abatacept) subcutaneous administration option for patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA). 2017 Jun 8.
- U.S. Food and Drug Administration. Drugs@FDA: FDA approved drug products—diclofenac sodium 2% topical solution. 2017 May 15.
- U.S. Food and Drug Administration. Drugs@FDA: FDA approved drug products—Pennsaid (diclofenac sodium 2% topical solution). 2014 Jan 16.
- Kocjan T, Rajic AS, Sever MJ et al. The effect of denosumab or bisphosphonates in women with severe postmenopausal osteoporosis after completion of teriparatide treatment. Endocrine Abstracts. 2017:49[abstract OC10.4].
- Berrie C. Denosumab more effective than bisphosphonates in treating severe, post-menopausal osteoporosis post-teriparatide: Presented At ECE. First Word: Pharma. 2017 May 26.
