Denosumab boosted bone mineral density (BMD) over 12 months to a better extent than did alendronate in a randomized, 12-month behold. The investigator-initiated be taught when put next BMD at the lumbar backbone and in completely different places among of us with systemic lupus erythematosus (SLE) and other autoimmune prerequisites. Prolonged-term glucocorticoid treatment locations some of us in this community at better possibility for negative outcomes of bone density loss.
“Glucocorticoids live the mainstay of treatment of rheumatic ailments, but [they are] a predominant possibility element for osteoporosis and smash,” behold author Chi Chiu Mok, MD, stated in an interview.
In contrast with baseline, adults randomly assigned to denosumab had a 3.5% amplify in lumbar backbone BMD at 12 months, when put next with 2.5% among these taking alendronate, a predominant difference. Mok, a specialist and honorary accomplice professor in the department of treatment and nuclear treatment at Tuen Mun Hospital in Hong Kong, provided the behold outcomes at the virtual annual assembly of the American College of Rheumatology.
“Given the knowledge that denosumab is more efficient than alendronate in elevating spinal BMD in persistent customers of GCs without increasing negative occasions, this drug could well well be considered as a change first-line treatment in better-possibility patients and in of us that are contraindicated for the oral bisphosphonates,” he stated.
Value Concerns
Denosumab is a human monoclonal antibody administered as a subcutaneous injection, readily available in the market beneath the logo names Prolia and Xgeva. Alendronate is an oral agent readily available in the market as each and each generic and ticket determine formulations.
“Disappear, denosumab is more costly, more costly than oral alendronate, but our behold reveals efficacy is healthier for steroid customers,” Mok stated in reply to a ask about ticket disparity between the 2 brokers throughout his presentation at the assembly. “For patients who’re contraindicated or comprise low compliance for bisphosphonate, or are high-possibility patients, I counsel first-line expend of denosumab.”
Researchers previously studied these brokers, including a smaller behold by Mok and colleagues that showed a BMD benefit after switching of us on an oral bisphosphonate to denosumab. Alternatively, he stated, “There could be a paucity of files relating to comparative efficacy of denosumab and the bisphosphonates in long-term steroid customers.”
To explore any variations in a better affected person population, the investigators randomly assigned adults with SLE and other autoimmune prerequisites to the 2 remedies: denosumab 60 mg subcutaneoulsy every 6 months or oral alendronate 70 mg/week. All patients also bought 3,000 mg calcium and 1,000 IU vitamin D3 (cholecalciferol) day after day.
After three discontinuations in denosumab cohort and 4 in the alendronate community, the researchers evaluated 69 of us taking denosumab and 70 others taking alendronate. The discontinuations were introduced on by noncompliance, Mok stated, no longer by negative occasions.
Unfavorable occasions were reported, however the fee did now not fluctuate vastly between groups. Mok highlighted some indispensable variations, including more minor infections and arthralgias reported in the denosumab cohort. Chest discomfort became as soon as reported in a single denosumab recipient versus no patients in the alendronate community. Dyspepsia/upper GI signs and dizziness/vertigo happened more usually in the alendronate community.
Females were 96% of the behold population, and mean age became as soon as 50 years. A majority, 81%, had underlying SLE. Various diagnoses integrated rheumatoid arthritis, myositis, antineutrophil cytoplasmic antibody–connected vasculitis, and polymyalgia rheumatica. The mean dose of prednisolone at behold entry became as soon as 5.1 mg/day.
Key BMD and Biomarker Findings
BMD increased vastly in the backbone, hip, and femoral neck in each and each treatment groups by 12 months. Alternatively, after adjustment for baseline BMD and covariates including age, menopause, and history of smash, the good points in the denosumab community were vastly better.
The amplify in lumbar backbone BMD at 12 months of three.5% in the denosumab community versus 2.5% in the alendronate community became as soon as statistically predominant (P = .045). Much less predominant became as soon as a 0.9% amplify at the hip in the denosumab patients versus 1.6% in the alendronate community (P = .10), as properly as femoral neck BMD good points of 1% in the denosumab community versus 1.5% in the alendronate community (P = .86).
Furthermore, “denosumab became as soon as stronger in suppressing the bone markers at 12 months,” Mok stated.
Particularly, the share lower in serum PINP (procollagen form I N-terminal propeptide) ranges in the denosumab community became as soon as vastly better than in the alendronate community (P = .001). Likewise, the lower in CTX (C-terminal telopeptide of form I collagen) became as soon as vastly better in the denosumab cohort versus the alendronate cohort (P < .001).
“Dr Mok’s behold became as soon as a properly-managed investigation. The superiority of denosumab became as soon as impressive, especially given the shrimp community sizes of 69 and 70,” session comoderator Gregg Silverman, MD, professor in the department of within treatment and the department of pathology at Recent York College, stated when requested for commentary.
“Alternatively, bone density measurements could well well no longer pronounce your complete myth. These outcomes enhance a greater and far better-scale behold to substantiate that charges of smash on denosumab are also reduced.”
No new symptomatic fractures happened in either community throughout the behold. The investigators are evaluating for any new radiologic fractures, with outcomes pending.
Mok stated “outcomes of our behold in Asian patients are largely confirmatory” of a earlier 2018 comparability behold and a 2019 comparability behold, every backed by Amgen.
A shrimp sample size, immediate duration of treatment, and the starting up-label make were obstacles of the behold.
The trial became as soon as an investigator-initiated behold. Mok and colleagues had no relevant monetary disclosures. Silverman had no relevant monetary disclosures.
SOURCE: Mok CC et al. Arthritis Rheumatol. 2020;72(suppl 10). ACR 2020, Summary 1442.
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