Abaloparatide - Osteoporosis

Abaloparatide is a human parathyroid hormone related peptide [PTHrP(1-34)] analog, is specifically indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. This received FDA approval in April 2017. Recommended dosage is 80 mcg subcutaneously once daily along with supplemental calcium and vitamin D if dietary intake is inadequate.

Clinical trial

The FDA approved Abaloparatide was based on the results at 18 months from ACTIVE trial and first six months of ACTIVExtend trial. Subjects were randomized to receive Abaloparatide 80 mcg (N = 824) or placebo (N = 821) given subcutaneously once daily. Data demonstrated consistent significant and rapid reductions in the risk of vertebral and nonvertebral fractures regardless of age, years since menopause, presence or absence of prior fracture (vertebral or nonvertebral) and bone mineral density (BMD) at baseline. Specifically, in the ACTIVE trial, Abaloparatide demonstrated significant reductions in the relative risk of new vertebral and nonvertebral fractures compared to placebo: 86% in new vertebral fractures and 43% in nonvertebral fractures. The absolute risk reductions were 3.6% and 2.0%, respectively.

Side Effects

Adverse effects associated with the use of Abaloparatide may include, but are not limited to, the following:hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, vertigo

Sarilumab- RA

Sarilumab (Kevzara) is an interleukin-6 (IL-6) receptor antagonist. Approved by FDA in May 2017 for active moderate to severe rheumatoid arthritiswho have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).The recommended dosage of Sarilumab is 200 mg once every two weeks, administered as a subcutaneous injection.

Clinical trial

In the MOBILITY trial, treatment with Sarilumab plus MTX reduced signs and symptoms, improved physical function, and demonstrated significantly less radiographic progression of structural damage, compared to placebo plus MTX. In TARGETclinical trialSarilumab plus DMARD reduced signs and symptoms and improved physical function, compared to placebo plus DMARD at 24 weeks.

Side effects

Adverse effects associated with the use of Sarilumab may include, but are not limited to, the following; neutropenia, increased ALT, injection site erythema, upper respiratory infections, urinary tract infections

Tocilizumab for GCA

GIACTA (NCT01791153) proved the efficacy and safety of tocilizumab in treating GCA at Week 52. More than 251 patients in 14 countries were enrolled.In GiACTA, when tocilizumab was initially combined with a six-month glucocorticoid regimen, it more effectively sustained disease remission through one year than glucocorticoids. The rates were 56% for patients treated weekly with tocilizumab and 53% for patients treated bi-weekly with tocilizumab compared with patients who received steroid monotherapy tapered over six months (14% remission rate) or 12 months (17.6% remission rate).

This is first new treatment for GCA in more than 50 years which has been approved by FDA

DPP4 (Dipeptidyl peptidase-4) inhibitors for Diabetes

There is a new warning and precaution issuedabout the risks of severe and disabling polyarthritis related to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors used to treat diabetes. Drugs in this class include alogliptin, linagliptin, saxagliptin and sitagliptin.

The onset of joint pain in patients taking these therapies can occur at any time during treatment, from one day to years after starting the drug therapy. Patients experienced symptom relief after discontinuing the medication. When re-challenged with a DPP-4 inhibitor, some patients had a recurrence of severe joint pain.

Compiled by :