Rheum in Review: Good News for Coffee Drinkers, Fracture Risk Drug Comparison, FDA Approvals, and More

Here are the top stories covered by DocWire News this week in the Rheumatology section. In this edition, learn about how coffee and tea do (or do not) affect rheumatoid arthritis risk, the latest Food and Drug Administration approvals in the rheumatology world, the ideal length of antibiotic therapy for native joint bacterial arthritis patients, and fracture risk for denosumab compared to alendronate.

Coffee or tea? This may help you decide. A long-term study found that women who drank coffee did not have an increased risk for rheumatoid arthritis (RA)—regardless of whether the coffee was caffeinated, how much of it was consumed, or how it was prepared (filtered versus unfiltered)—but those drinking non-herbal tea had a slightly higher chance of incident RA: “There was a positive association of incident RA and caffeinated tea consumption in the trend test (p = 0.03). When assessing any caffeinated tea consumption versus no tea consumption, the hazard ratio for incident RA was 1.40 (confidence interval, 1.01–1.93; p = 0.04).” The Arthritis Foundation’s website features a list of drinks with anti-inflammatory properties that could benefit arthritis patients; among them is, incidentally, tea. Other drinks include coffee, milk, fruit juices, smoothies, and water. The list also discusses alcohol consumption, advising that women limit their alcohol intake to one drink a day and men consume no more than two daily drinks.

Researchers recently compared the risk for hip fracture and overall fracture associated with osteoporosis drugs denosumab (PROLIA from Amgen) and alendronate. Danish health registry data were gathered for 92,355 denosumab and alendronate initiators aged ≥ 50 years. Mean patient age was 71 years old and the majority (81.3%) were female. There were 4,624 denosumab initiators and 87,731 alendronate initiators. The alendronate group had a higher proportion of male patients than the denosumab cohort (19% vs. 12.7%). Patients were followed for three years. Cumulative hip fracture incidence was similar between the groups: 3.7% in the denosumab group and 3.1% in the alendronate cohort. Both cohorts had a 9.0% incidence of overall fracture. Separate analyses were conducted based on fracture history. Comparing denosumab versus alendronate, hip fracture adjusted hazard ratio (aHR) for patients with any prior fracture was 1.07 (95% CI, 0.85-1.34), and for patients with no fracture history, it was 1.05 (95% CI, 0.83-1.32). Making the same comparison for overall fracture, aHR among patients with previous fracture was 0.84 (95% CI, 0.71-0.98), and for those without previous fracture was 0.77 (95% CI, 0.64-0.93).

The Food and Drug Administration (FDA) has recently granted two approvals: Risankizumab-rzaa, manufactured by AbbVie under the name SKYRIZI, is an interleukin-23 antagonist indicated to treat adults with moderate-to-severe plaque psoriasis. The drug is administered via two 75 mg injections at Week 0 and Week 4, and then every 12 weeks. Its approval follows four clinical trials, including two that were published in The Lancet: UltIMMa-1 and UltIMMa-2, both of which were randomized, double-blind, placebo-controlled and active comparator-controlled trials. Both studies had the same primary endpoints, which were met in both studies: patients achieving a 90% improvement in the Psoriasis Area Severity Index and a static Physician’s Global Assessment score of 0 or 1 at week 16.

The second FDA approval was for belimumab, sold under the brand name Benlysta from manufacturer GlaxoSmithKline (GSK). This is a first-of-its-kind approval: while the intravenous infusion treatment has been indicated for adults with systemic lupus erythematosus (SLE) since 2011, it is now approved for pediatric SLE patients. The drug received approval under the FDA’s Priority Review, meaning the FDA expedited the usual 10-month process and committed to taking action within six months. This new indication follows the randomized controlled PLUTO trial, which evaluated 93 SLE patients aged between five and 17 years with active disease who were on a stable treatment regimen for ≥ 30 days prior to the start of the study. Patients received either 10 mg/kg IV belimumab or placebo. The belimumab group had a higher proportion of patients achieve SLE response index (SRI-4) than the placebo group. The FDA further reported, “Pediatric patients who received Benlysta IV plus standard therapy also had a lower risk of experiencing a severe flare, as well as longer duration of time until a severe flare (160 days versus 82 days).”

Contrary to current recommendations, a new study found that a shorter course of antibiotic therapy may not be inferior to prolonged treatment in patients who underwent surgical drainage for native joint bacterial arthritis. The single-center study included 154 cases; 77 each received two weeks and four weeks of antibiotic treatment. Recurrent infection occurred in three patients: one in the two-week group (99% cure rate) and two in the four-week group (97% cure rate). There were no between-group differences in the number of adverse events or sequelae. Since most cases pertained to the hand and wrist (n = 99), a subgroup analysis was conducted. This group saw three recurrences: one in the two-week arm (97% cure rate) and two in the four-week arm (96% cure rate). Half of the two-week cohort presented sequelae, as did 55% of the four-week patients, and five and six patients, respectively, required further intervention.