AbbVie expects Skyrizi, Rinvoq to eclipse Humira's sales peak: CEO

 As U.S. biosimilars put AbbVie’s megablockbuster Humira on watch, the company is already congratulating its immunology successors Rinvoq and Skyrizi on jobs well done.

Thanks to the pair of meds’ “outstanding” launches—which are pegged to deliver some $7.5 billion in combined sales this year—AbbVie now has a “high degree of confidence” in Rinvoq and Skyrizi’s potential to “ultimately exceed the peak revenues achieved by Humira,” CEO Rick Gonzalez told investors Friday.

Should that prediction come to pass, AbbVie will have achieved “the strategic objective we had for replacing Humira,” the CEO said on the company’s third-quarter earnings call.

Skyrizi in particular has continued to “exceed our expectations,” AbbVie Chief Commercial Officer Jeffrey Stewart added on the call. He noted that in psoriasis, Skyrizi is now capturing nearly “one out of every two new and switching patients in the U.S. biologic market,” with the company’s leading total prescription share now clocking in at roughly 27%.

The med is “ramping very nicely” in psoriatic arthritis, too, where it’s expected to chip in roughly $500 million in 2022 sales alone. Skyrizi’s Crohn’s disease launch is also “progressing very well,” Stewart pointed out.

Rinvoq, for its part, continues to gain “positive momentum” in rheumatoid arthritis. At the same time, global prescriptions are “also ramping nicely” in psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis, the AbbVie CCO explained.

Even with all the attention on its immunology heirs apparent, the drugmaker isn’t throwing in the towel on Humira just yet.

“Our intent has always been to maintain broad formulary access so that we can compete effectively with forthcoming biosimilars,” Gonzalez said.

At present, the company foresees formulary access of at least 80% of all U.S. covered lives, with that percentage set to increase as the company hashes out additional contract discussions “between now and the end of the year,” the CEO added.

“As a result, we anticipate strong access for U.S. Humira throughout 2023 and project biosimilars will share access as they become available,” he explained.

The company isn’t issuing 2023 sales guidance on Humira just yet, with Gonzalez saying AbbVie plans to do so on its fourth-quarter earnings call. Still, he hinted at what’s to come for the company overall: “[W]hen we issue our EPS outlook, we expect the lower end of the range to represent floor earnings,” Gonzalez said, noting many investors are interested in determining whether AbbVie will see “trough earnings” in 2023 and 2024, following Humira’s decline.

The executives’ comments came as AbbVie reported total third-quarter sales of $14.81 billion, up 5.4% operationally. Immunology continued its reign as the company’s top business overall, growing revenues more than 16% to $7.651 billion.

Over the three-month stretch, Humira remained the star of the show as Rinvoq and Skyrizi wait in the wings. Those gains helped offset “temporary economic headwinds” plaguing AbbVie’s aesthetics business, which pulled down $1.3 billion for the period, Gonzalez said in a statement in the company’s earnings press release.

In its last third quarter of true market supremacy, Humira carried its weight in the U.S., lifting sales 7.4% to $4.96 billion. The drug fared worse in international markets, where biosimilars are already taking a toll. Ex-U.S., the drug pulled down $603 million, marking a 16.8% operational revenue plunge.

With U.S. biosimilars to Humira expected to encroach starting in January, AbbVie has big hopes riding on Rinvoq and Skyrizi. At the start of the year, the company prophesized combined peak sales of more than $15 billion for the meds by 2025.

Humira, for its part, delivered a $20.7 billion sales high last year. As the world’s all-time best-selling drug, Humira has generated more than $200 billion over the course of some 20 years.

For now, meanwhile, launch siblings Rinvoq and Skyrizi appear to be growing nicely.

Skyrizi generated about $1.4 billion for the quarter, climbing 78.3% operationally, while Rinvoq lifted sales 59.3% to $695 million.

Rinvoq just nabbed its sixth FDA approval, too. Earlier this week, the drug bagged a green light to treat adults with active non-radiographic axial spondyloarthritis (nr-axSpA). The approval specifically covers patients with objective signs of inflammation who’ve either failed on or weren’t suitable for tumor necrosis factor (TNF) blockers like Humira.

On the biosimilar front, Amgen is the first company getting a crack at competition with its copycat Amjevita, set to launch in January 2023. It will be followed by the likes of Coherus, Fresenius Kabi, Pfizer, Samsung Bioepis, Sandoz and Viatris.

https://www.fiercepharma.com/pharma/abbvie-expects-skyrizi-and-rinvoq-eclipse-humiras-sales-peak-ceo-gonzalez-says

Want a weapons-free subway? Enforce farebeating

 Another weekend, another spate of subway stabbings, almost unheard-of in the quarter-century before 2020.

To commit a stabbing or a shooting in the subway system, you need a knife or a gun. We know how to keep weapons and the people who use them out of transit — because we’re already doing it, and it’s working. It’s just that the scale of the problem has grown so much.

Early Saturday, an assailant stabbed a 23-year-old man in the stomach and leg at a Times Square station. Early Friday, a different assailant stabbed a city fire inspector at a station in Harlem.

These latest attacks are just more reminders that serious subway crime, as of last week, is 42% above last year’s already-elevated levels. 

One way to prevent people from carrying deadly weapons into the subway system is to stop them at the faregate.

New York has known for 30 years that knife- and gun-toters aren’t likely to pay their fares. Back then, Transit Police Chief Bill Bratton brought order to the subways by stopping criminals at the faregate. This philosophy helped bring annual subway murders from 26 in 1990 to an average of 1 to 2 a year from 1997 to 2019.

And we have fresh evidence this strategy still works. Twice in two days in late October, police stopped farebeaters at a Coney Island subway station — and found them carrying loaded guns.

Two men were stabbed inside the subway at W 42nd St.

Seth Gottfried

On Oct. 18, police caught 23-year-old Kayvill Voliton entering without paying — and found he had a loaded pistol and was wanted for an earlier crime. And what do you know? A Brooklyn judge actually held him without bail.

A day later, police similarly caught 20-year-old Wilfredo Serrano walking into the same station through the exit gate without paying — and found a loaded .357. So far, Serrano is luckier than Voliton; despite being a person of interest in an earlier shooting, a judge set $20,000 bail, which he paid.

And late last week, cops caught a panhandler, 46-year-old Jermal Vives, suspected of having slashed a passenger at 50th Street and Broadway earlier this month after the victim ignored his request for money.

How did they catch him? Once again, this time in Washington Heights, he walked through the exit gate without paying his fare. Like Voliton, he’s now sitting at Rikers, on $1,001 bail. 

How else do we know this type of police action in the subways works? This year, through Oct. 23, police have recovered 711 weapons from suspects in the subway system, most of them via stops for “minor” offenses such as farebeating. That’s 27 guns and 684 knives. 

The numbers are way up from last year, when over the same time period police had recovered 359 weapons: 21 guns and 338 knives.

How is that? Because enforcement is way up. Through September, farebeating arrests in the subway system are nearly double last year’s level, and civil summonses for the same offense are up 34%.

The increasing subway crimes has New Yorkers fearful of their safety.

Seth Gottfried

But it is just not enough. More people are carrying weapons, in part because they themselves are fearful of violence, and the presence of these weapons can make a dispute deadly. 

And after two years of near-nonexistent enforcement in 2020 and 2021, far more people are beating the fare — 12.5% of subway riders, as of early this year, up from 3.9% before the pandemic.

It’s simply harder for cops to stop everyone. 

The Metropolitan Transportation Authority is so intent on halting this lawlessness that it has hired civilian, unarmed security guards at six key stations.

These guards can serve a purpose. Some people who just got used to riding without paying will think twice about brazen theft in front of watchful eyes.

But despite what progressive activists will tell you, the unarmed guards won’t replace cops. The guards won’t stop a farebeater who ignores their warnings, and they can’t arrest a suspect and then find that he is carrying a gun or a knife.

For that, we still need armed police — and a city and state government willing to keep repeat offenders out of the transit system, including through mandatory mental-health treatment for the seriously ill. 

Slowly, slowly, New York must relearn the lessons it first learned three decades ago — and with nine people killed on subways this year so far, it must relearn these lessons expensively.

Nicole Gelinas is a contributing editor to the Manhattan Institute’s City Journal.

https://nypost.com/2022/10/30/want-a-weapons-free-subway-enforce-farebeating/

US Hospitals On Track For Worst Financial Year In Decades

 By Nathan Tucker, of Becker Hospital Review

Healthcare systems in the U.S. have had a challenging year, and they are on track for their worst financial year in decades, according to an Oct. 25 report from Health Affairs.

Dramatic margin fluctuations have characterized 2022, and U.S. hospitals are still operating substantially below pre-pandemic levels. Most metrics improved month-over-month in August as revenues and expenses climbed compared to July. However, most organizations are in poor shape with a negative operating margin, according to the report. 

Several factors suggest hospital margins will continue to face challenges in the coming years. The labor shortage is noted as the primary driver for rising hospital costs. Nursing labor is a critical point as the report indicates hospitals have lost about 105,000 employees, and nursing vacancies have more than doubled. In response, hospitals have relied on expensive contract nurses and extended overtime hours, which caused labor costs to surge. The national nursing shortage is a continuing problem as a substantial segment of the labor force is approaching retirement, and the shortage of new nurses is projected to reach 450,000 by 2025. 

Payment rates will eventually adjust to rising costs, which are likely to occur slowly and unevenly, according to the report. Medicare rates, adjusted annually based on inflation, are projected to undershoot hospital costs and are expected to widen the gap between costs and payments. 

Economic uncertainty and the threat of recession are expected to create continued disruptions in patient volumes. While healthcare has been referred to as "recession-proof," high-deductible healthcare plans and more aggressive cost-sharing mechanisms have exposed patients to costs, making them more likely to weigh them against other household expenditures. 

Combined, these factors suggest that the current financial pressures are unlikely to resolve in the short term.

https://www.zerohedge.com/markets/us-hospitals-track-worst-financial-year-decades

Metastasis-Directed Therapy for Prostate Cancer Increases PFS, Time off Hormones

 Metastasis-directed radiotherapy (RT) significantly prolonged response to androgen deprivation therapy (ADT) in oligometastatic prostate cancer as compared with ADT alone, a small randomized trial showed.

Median progression-free survival (PFS) had yet to be reached with combined therapy after a median follow-up of 22.1 months, but the hazard for disease progression or death was reduced by 75% versus ADT alone, which led to a median PFS of 15.8 months. Metastasis-directed therapy also extended the duration of eugonadal PFS (testosterone >150 ng/dL) during a planned break from ADT, reducing the side effects of hormonal therapy.

"Metastasis-directed therapy combined with hormone therapy as part of an intermittent regimen improves PFS and thus time off from hormone therapy," said Chad Tang, MD, of the University of Texas MD Anderson Cancer Center in Houston, during a press briefing at the American Society for Radiation Oncology (ASTRO) annual meeting.

"Importantly for men, metastasis-directed therapy combined with hormone therapy also improves time with eugonad testosterone, something they all can enjoy," he added. "Intermittent hormone therapy in combination with metastasis-directed therapy may facilitate prolonged eugonad testosterone intervals while maintaining excellent disease control in men with this disease."

Multiple studies have shown that upfront (vs delayed) hormonal therapy improves overall survival in prostate cancer and has synergistic anticancer activity with RT. Hormone therapy also has well-known short- and long-term side effects, including changes in appearance, mood, sexual function, and musculoskeletal integrity.

"We know that men generally hate hormone therapy and that it's a big quality-of-life detriment to them," said Tang.

The SWOG S9346 trial in men with metastatic prostate cancer showed that intermittent hormone therapy was noninferior to continuous therapy, and planned drug holidays may reduce total exposure to anti-androgen therapy and its adverse effects. However, characteristics of the SWOG S9346 patient population might limit applicability of the findings to men with oligometastatic prostate cancer, Tang noted. The patients had a median prostate-specific antigen (PSA) value of 42 ng/dL at diagnosis, most of the patients had undetectable PSA levels after 7 months of ADT, and investigators had a high PSA threshold of ≥20 ng/dL for restarting ADT.

Acceptance and use of metastasis-directed therapy in oligometastatic prostate cancer have increased in recent years. However, use in combination with ADT had not been evaluated in a randomized trial.

Tang reported findings for prostate cancer from EXTEND, a phase II randomized basket trial of add-on metastasis-directed therapy in various types of solid tumors. The prostate cancer part of the trial included 87 men with five or fewer metastases on hormone therapy for at least 2 months, who were randomized to continue hormone therapy alone (LHRH agonist/antagonist with or without a second-generation androgen receptor-targeting agent) or hormone therapy plus metastasis-directed RT.

A planned break in hormone therapy occurred after 6 months and continued until progression, defined as biochemical progression (≥2 ng/mL or ≥25% increase from nadir), clinical progression (symptoms or need to restart hormone therapy), or radiographic progression. The primary endpoint for the prostate cancer study was PFS, and the key secondary endpoint was eugonadal PFS.

The trial met the primary endpoint of PFS (95% CI 0.12-0.55, P<0.001). The addition of metastasis-directed therapy also significantly extended the time from eugonadal testosterone levels to disease progression (6.1 months with ADT vs not yet reached, P=0.025). A subgroup analysis showed that metastasis-directed therapy improved PFS in men who received a second-generation androgen receptor-targeting agent (HR 0.24, 95% CI 0.08-0.71) and those who did not (HR 0.36, 95% CI 0.15-0.83).

Grade 3 toxicity was limited to three cases in each treatment arm.

RT is one of several types of metastasis-directed therapies used to treat individual cancer lesions, said ASTRO president-elect Howard Sandler, MD, of Cedars-Sinai Medical Center in Los Angeles. Though he quibbled about the lack of details for the study's radiation therapy protocol, Sandler concluded, "However it was performed, it worked because the delay in time to progression is dramatic."

"Men who received relatively convenient, low-toxicity radiation to their metastatic sites were able to have extended time off of hormonal therapy," Sandler added. "As a prostate cancer-treating physician, I can tell you that this is clinically meaningful to patients. If we can extend their time off hormonal therapy with a eugonad testosterone level, basically having a normal testosterone level, receiving no therapy, then their quality of life is improved. Having taken care of many, many patients, mentally, these people are happier. So it's subjective improvement and quality of life."

Disclosures

The study was sponsored by MD Anderson Cancer Center in collaboration with the National Cancer Institute.

Tang reported relationships with Bayer and Diffusion Pharmaceuticals, as well as patent/royalty/intellectual property interests.

Sandler did not report any relevant relationships with industry.

Primary Source

American Society for Radiation Oncology

Source Reference: Tang C, et al "Addition of metastasis-directed therapy to intermittent hormone therapy for oligometastatic prostate cancer (EXTEND): a multicenter, randomized, phase II trial" ASTRO 2022; Abstract LBA 05.

https://www.medpagetoday.com/meetingcoverage/astro/101462

Mixed results with green light therapy for fibromyalgia

 Researchers continued to build a case for green light therapy in the chronic pain population, despite rocky preliminary data from a small randomized trial.

Among 34 opioid users with fibromyalgia, the 12 randomized to wear green glasses trended nonsignificantly toward reduced anxiety on the PROMIS-57 scale compared with peers who wore blue or clear glasses instead (median -3 vs +3.5 vs +2 points, P=0.11).

The null result persisted upon adjustment for age and compliance, but there was a signal that green glasses could reduce fear-based anxiety in particular (P=0.03), reported Amanda Nelli, MD, a postdoctoral researcher at Duke University Medical Center in Durham, North Carolina, at this year's American Society of Anesthesiologists (ASA) annual meeting.

"We found that although their pain scores remained the same, those who wore the green eyeglasses used fewer opioids, demonstrating that their pain was adequately controlled," noted co-author Padma Gulur, MD, also at Duke, in a press release.

"Our research found that certain wavelengths of green light stimulate the pathways in the brain that help manage pain," Gulur said. "There is an urgent need for additional treatments to reduce the use of opioids among patients with fibromyalgia and other types of chronic pain, and green eyeglasses could provide an easy-to-use, non-drug option."

The hypothesis is supported by the literature linking anxiety to higher opioid use and showing that pain shares similar biological mechanisms with anxiety.

Nelli noted that many patients taking opioids for chronic pain are reluctant to decrease their regimen due to the fear of severe pain, and this fear-based anxiety can lead to the escalation of opioid use. In order to successfully decrease or eliminate opioid use in these individuals, their anxiety must also be addressed, she said.

Pain medicine specialist Mohab Ibrahim, MD, PhD, of Banner-University Medical Center and the University of Arizona, Tucson, and colleagues previously showed in a small trial that green LED exposure was associated with a reduction in average pain intensity in people with fibromyalgia. In another report, they found that green LED exposure was linked with fewer headache days in people with episodic and chronic migraine.

The new research from Duke is "very exciting news" and "confirms our findings," Ibrahim told MedPage Today.

"I think if they increased the treatment time from 4 weeks to maybe 8 or 12 weeks, the results would have been statistically significant," he said.

For the study, fibromyalgia patients were randomized to blue, unfiltered, or green light therapy and were instructed to wear their assigned glasses for at least 4 hours per day for 2 weeks.

Nelli and team cautioned that they started with 45 people randomized and ended with 34 completing the study; four individuals had been added to the clear glasses group because of a lower initial completion rate related to excess adverse events (namely headaches).

Participants completed the PROMIS-57 questionnaire at baseline and at 2 weeks after intervention.

Gulur said the group is also pursuing research on green eyeglass treatment for patients with other chronic pain conditions.

"There still remains some skepticism about phototherapy in general and green light therapy in particular," Ibrahim noted. "I hope these results will encourage other researchers to look into phototherapy [as] a new platform of medicine to manage many medical conditions."

Disclosures

Nelli had no disclosures.

Ibrahim disclosed an outside interest in Luxxon Therapeutics to the University of Arizona.

Primary Source

American Society of Anesthesiologists

Source Reference: Nelli A, et al "Effects of light induced analgesia on anxiety for fibromyalgia patients" ASA 2022.

https://www.medpagetoday.com/meetingcoverage/asa/101375

New Evidence Sheds Light on Stem Cell Transplantation for Progressive MS

 Autologous hematopoietic stem cell transplantation (AHSCT) was not superior in preventing relapses or reducing disability progression than natalizumab (Tysabri) in progressive multiple sclerosis (MS), new research suggested.

Patients with progressive MS, advanced disability, and low pre-treatment relapse activity who had AHSCT experienced similar on-treatment frequency of relapses as matched patients treated with natalizumab over up to 6 years, according to Tomas Kalincik, PhD, of the Royal Melbourne Hospital in Australia.

Cumulative hazards of confirmed worsening on the Expanded Disability Status Scale (EDSS) and disability improvement also were similar, Kalincik said in a late-breaking presentation at the 2022 meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

"What we know about the use of AHSCT in progressive disease is mostly fueled by information we have learned primarily through relapse and remitting disease," Kalincik said. Chemotherapy followed by AHSCT is used to treat aggressive forms of relapsing MS and "occasionally people with progressive disease forms may be exposed to this therapy," he pointed out.

A recent Italian cohort study showed AHSCT was associated with slower progression of disability compared with a matched composite group of disease-modifying therapies. "But patients with progressive MS tended to accumulate disability more often than those with relapsing MS," Kalincik noted. "And unlike in relapsing MS, where you see the stabilization of disability, we did not see the same trend in progressive disease."

Kalincik and colleagues studied people with secondary or primary progressive MS from six AHSCT MS centers around the world and participants in the international MSBase registry.

People were included in the study if they received AHSCT or started natalizumab during progressive MS. Natalizumab was chosen as a comparator because ocrelizumab (Ocrevus) had not been approved in several locations during the course of the study, Kalincik said.

Participants were propensity score-matched on sex, age, EDSS score, number of relapses 12 and 24 months before baseline, time from MS onset, most effective prior therapy, and country (EDSS scores range from 0 to 10, with higher numbers representing more disability). Participants were followed for up to 6 years.

Overall, 39 people who received AHSCT and 65 natalizumab-treated patients were matched. Mean EDSS at baseline was 5.7 in both groups, indicating moderately advanced disease. The AHSCT group had a mean baseline age of 36.8 and 35.9% were men. The natalizumab group had a mean baseline age of 43.9 and 30.8% were men. In both groups, most patients had secondary progressive disease.

The mean annualized relapse rate (ARR) was 0.08 with AHSCT and 0.08 with natalizumab. The hazard ratio (HR) for relapses was 1.05 (95% CI 0.39-2.82, P=0.92).

Cumulative hazards of 6-month confirmed worsening on EDSS (HR 1.49, 95% CI 0.70-3.14. P=0.30) and confirmed disability improvement (HR 1.50, 95% CI 0.22-10.28, P=0.67) also were similar. "Confirmed disability improvement was rarely observed both in the AHSCT and natalizumab groups," Kalincik said.

At year 2, the probability of disability worsening was 36% with AHSCT and 22% with natalizumab. At year 5, those probabilities were 45% with AHSCT and 22% with natalizumab.

In the AHSCT group, three patients (7.7%) experienced febrile neutropenia, nine (23%) had serum sickness, six (15%) required ICU admission, and 36 (92%) developed complications after discharge, including 21 infections. No treatment-related deaths were reported.

The analysis had several limitations, Kalincik acknowledged. There was no randomization and cohort sizes were small. The cohorts could not be matched on MRI, and MRI data were not available as an outcome. In addition, complete safety data were not available for the natalizumab group.

Disclosures

Kalincik disclosed relationships with, and/or support from, Bristol Myers Squibb, Roche, Janssen, Sanofi Genzyme, Novartis, Merck, Biogen, Brain Atrophy Initiative by Sanofi Genzyme, WebMD Global, Eisai, Novartis, Teva, BioCSL, Merck, Genzyme, and Celgene.

Primary Source

European Committee for Treatment and Research in Multiple Sclerosis

Source Reference: Kalincik T, et al "Effectiveness of autologous haematopoietic stem cell transplantation in comparison with natalizumab in progressive MS" ECTRIMS 2022; Abstract O181.

https://www.medpagetoday.com/meetingcoverage/ectrims/101495

Walgreens-Controlled VillageMD Said to Explore Deal for Summit

 VillageMD, which is majority owned by Walgreens Boots Alliance Inc., is exploring a deal to merge with Warburg Pincus-backed Summit Health, according to people familiar with the matter.

The acquisition by primary-care provider VillageMD of Summit, a health-care network and the parent of CityMD, would value the combined entity at between $5 billion to $10 billion, said the people, who asked to not be identified because the matter isn’t public.

An agreement could be reached in the coming weeks, though talks could still fall apart, the people added. Representatives for VillageMD, Walgreens and Warburg Pincus declined to comment, while Summit Health didn’t immediately respond to a request for comment.

The talks come as Walgreens rivals including CVS Health Corp. and Amazon.com Inc. push deeper into primary health care through major acquisitions. Walgreens agreed to more than double its stake last year in VillageMD to 63% from 30% by investing $5.2 billion in the company.

Under Chief Executive Officer Roz Brewer, Walgreens has been adding primary-care centers to its US retail locations, partnering with health insurers and buying out its remaining stakes in CareCentrix and Shields Health Solutions. In October, it appointed John Driscoll, CareCentrix’s CEO, as president of Walgreens’s US health-care unit. The company has also launched an initiative to enroll patients in clinical trials.

Walgreens first invested in closely held VillageMD in 2020 with a goal of building as many as 700 primary care clinics inside its pharmacies. It said last year it would increase the number to 1,000 by 2027.

The company also considered selling its Boots drugstore chain earlier this year to better focus on North America, but pulled the sale after failing to fetch a good price.

https://finance.yahoo.com/news/walgreens-controlled-villagemd-said-explore-171747207.html