Rheum Round-up: Europe Rejects EVENITY, Tanezumab vs. Placebo for OA, and More

Here are the top stories covered by DocWire News this week in the Rheumatology section. In this edition, read about the European Union’s (EU) decision not to recommend an osteoporosis drug, outcomes for tanezumab compared to placebo, the effect of nutrition in pediatric arthritis, and the role of disease-modifying antirheumatic drugs in psoriatic arthritis compared to methotrextate.

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced it has adopted a negative opinion of EVENITY (romosozumab-aqqg), an osteoporosis drug for postmenopausal women with high fracture risk. The U.S. Food and Drug Administration (FDA) approved the drug, manufactured by Amgen in partnership with UCB, in April, but the approval came with a boxed warning for possible increased risk of heart attack, stroke, and cardiovascular death. “As it was unclear why the medicine appeared to increase the risk of heart and circulatory problems, and there was no obvious group of patients in whom the risk of these was lower, measures to reduce the risk could not readily be put in place,” the EMA stated in a release, adding that while the drug effectively reduced fracture risk in patients with severe disease, it was not as beneficial in patients with more mild osteoporosis. UCB, which filed the request, can apply for a request for re-examination by the CHMP within 15 days of the opinion being issued, which Amgen said in a press release it intends to do. (In case you missed it: Here’s how EVENITY stacks up against its competitors.)

Patients with osteoarthritis (OA) of the hip or knee may benefit from tanezumab, according to a new randomized, double-blind, placebo-controlled study. The study—conducted between January 2016 and May 2018 and spanning 89 sites in the United States, Canada, and Puerto Rico—included a 16-week treatment period and a 24-week follow-up period. Patients aged ≥ 18 years with a diagnosis of hip or knee OA were eligible for inclusion; 582 completed the trial. Baseline mean Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Pain scores were 7.1 in the 2.5 mg tanezumab group, 7.3 in the 2.5/5 mg tanezumab group, and 7.3 in the placebo group; after 16 weeks, the scores decreased to 3.6, 3.6, and 4.4, respectively. Baseline mean WOMAC Physical Function scores were 7.2 in the 2.5 mg tanezumab group, 7.4 in the 2.5/5 mg tanezumab group, and 7.4 in the placebo group, and decreased to 3.7, 3.6, and 4.5 respectively. The baseline mean PGA-OA scores were 3.4, 3.5, and 3.5 in the 2.5 mg tanezumab, 2.5/5 mg tanezumab, and placebo groups, respectively, and decreased to 2.4, 2.4, and 2.7, respectively.

A new cross-sectional study evaluated bone mass and strength levels in patients with psoriatic arthritis (PsA) based on whether they were treated with disease-modifying antirheumatic drugs (DMARDs). Specifically, the researchers concluded that biologic (b) DMARD-treated patients had better outcomes than those who received methotrexate or no DMARDs. The study included 165 PsA patients, of whom 79 received no DMARDs and 86 received DMARDs. In the DMARD group, 52 patients received bDMARDs, and 34 received methotrexate. Amon the bDMARD cohort, 31 patients used TNF inhibitors, including adalimumab (n = 13), etanercept (n = 9), infliximab (n = 6), certolizumab (n = 2), and golimumab (n = 1); 11 patients had a history of methotrexate treatment. Patients taking any DMARDs had higher total volumetric bone mineral density (vBMD) than the no-DMARD group, as well as higher trabecular vBMD. The DMARD group also had a higher number of trabeculae, lower trabecular separation, and higher cortical thickness. DMARD patients exhibited higher stiffness and failure load. The researchers further stratified the data by those treated with methotrexate versus bDMARDs and found that methotrexate had no impact on bone microstructure and functional properties, while the bDMARD group—compared to the no-DMARD group—had significantly higher total vBMD and trabecular vBMD, as well as higher cortical thickness and better outcomes regarding stiffness and failure load.

A new study found a significant association between exposure to metals—found in fish—and juvenile idiopathic arthritis (JIA). The prospective cohort study was part of the All Babies in Southeast Sweden-project (ABIS); 17,055 families agreed to participate. Biological samples were taken at birth and again at ages 1, 2.5, 5, 8, 10–12, and 13–16 years; questionnaires were also completed providing lifestyle and environmental data, and a diary was kept pertaining to nutrition and infection data. A total of 10,883 families completed the one-year questionnaires, and 9,849 diaries were available for review. Forty-two children eventually received a true JIA diagnosis, of whom 41 completed the post-delivery questionnaire, and 32 completed the post-delivery and one-year questionnaire. Of the 32 with both complete questionnaires, 29 had also filled out the nutrition and environmental data diaries. Eleven of the JIA patients had antinuclear antibody (ANA) positivity. The researchers analyzed heavy metals in the 42 JIA patients as well as 40 age- and sex-matched controls. “Fish consumption more than once a week during pregnancy was associated with an increased risk of JIA ([adjusted odds ratio] 4.5 (1.95–10.4); p < 0.001),” the researchers observed. “The child’s consumption of fish more than once a week during the first year of life was also associated with an increased risk of JIA (aOR 5.1 (2.1–12.4) p < 0.001), as illustrated in Table 1 and Fig. 2. 87% (27/31) of children with JIA was exposed to fish more than once a week during pregnancy or during their first year, compared to 56% in the general population (aOR 5.4 (1.9–15.4) p = 0.002).” There was also a significant correlation between fish consumption more than once a week during pregnancy and the child’s first year of life and ANA-positivity (aOR 2.2 (1.4–3.6); p = 0.002 and p < 0.001, respectively); all children with ANA-positivity reported more than once weekly fish consumption during their first year. Increased fish consumption at ages 2.5 and 5 years was not associated with ANA-positivity.