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Xeljanz Safety Study Final Findings Presented in January 2022

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The Xeljanz safety study final findings from the so-called “ORAL Surveillance” trial ordered by the FDA were examined in this January 26, 2022 article, “Trial Data Confirm Heightened Risks With JAK Inhibitor”, by medical news reporter John Gever for MedPage Today.

That January 2022 MedPage Today news report provides a “snapshot” of the current safety profile for Xeljanz as regards cancer and heart-related side effects:

It’s official: full data from a randomized trial evaluating safety of the oral JAK inhibitor tofacitinib (Xeljanz), approved for treating rheumatoid arthritis and related disorders as well as ulcerative colitis, are now published — and they are not good.

Patients assigned to [Xeljanz] developed major adverse cardiovascular events (MACE) at a rate of 3.4% and new cancers were seen in 4.2% during a median 4 years of follow-up; for those treated with either adalimumab (Humira) or etanercept (Enbrel), the corresponding rates were 2.5% and 2.99%, respectively, according to a report in the New England Journal of Medicine.

This worked out to hazard ratios of 1.33 for MACE (95% CI 0.91-1.94) and 1.48 for incident cancers (95% CI 1.04-2.09), reported investigators led by Steven Ytterberg, MD, of the Mayo Clinic in Rochester, Minnesota….

In their paper, Ytterberg and colleagues stuck to reporting the trial’s results, offering no advice to patients or clinicians on how to interpret them.

For more detail, the January 27, 2022 edition of the New England Journal of Medicine (NEJM) has this article, “Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis”, which reports all of the final data for this ORAL Surveillance Xeljanz safety study.

Our law firm is investigating possible Xeljanz, Rinvoq, and Olumiant lawsuits for patients who have suffered any of these serious side effects or adverse drug reactions. We would like to help you or someone you know with a Xeljanz, Rinvoq, or Olumiant drug injury case. Please feel free to contact us, at your convenience.

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Xeljanz Safety Alert for People Who Are (1) Older, (2) Current / Past Smokers, or (3) With Cardiovascular or Cancer Risk Factors

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This excerpt from the “Advisory – Health Canada safety review finds link between the use of Xeljanz and Xeljanz XR (tofacitinib) and increased risk of serious heart-related issues and cancer” issued in January 2022 provides an overview of the Xeljanz drug safety issue, and how the Xeljanz side effects risks may also apply to Olumiant and Rinvoq:

Health Canada completed a safety review that confirmed a link between the use of Xeljanz/Xeljanz XR and the increased risks of serious heart-related problems and cancer, especially in older patients, patients who are current or past smokers, and patients with cardiovascular or cancer risk factors. Health Canada’s review also found that all patients treated with Xeljanz 10 mg twice daily had a higher risk of death, blood clots and serious infections, compared to patients treated with Xeljanz 5 mg twice daily or tumour necrosis factor inhibitors (TNFi)….

Health Canada has also initiated a new safety review of the potential risks of serious heart-related problems, cancer and blood clots with two other drugs of the same class as Xeljanz/Xeljanz XR (i.e. Olumiant and Rinvoq) that work similarly for the treatment of similar diseases.

The Health Canada Xeljanz Advisory gives some more detailed information in a section intended for healthcare professionals but, no doubt, of interest to patients using Xeljanz — as well as Olumiant or Rinvoq, perhaps:

  • Inform patients that Xeljanz/Xeljanz XR may increase their risk of major adverse cardiovascular events including non-fatal myocardial infarction. Instruct all patients, especially geriatric patients, current or past smokers, or patients with other cardiovascular risk factors, to be alert for signs and symptoms of cardiovascular events.
  • Inform patients that Xeljanz/Xeljanz XR may increase their risk of certain cancers, and that lung cancer, lymphoma and other cancers have been observed in patients taking Xeljanz. Instruct patients to inform their healthcare provider if they have ever had any type of cancer.

Our law firm is investigating possible drug injury lawsuits for patients who used Xeljanz, Olumiant, or Rinvoq and then suffered one of the serious side effects associated with these JAK inhibitors drugs. In particular, heart problems such as heart attacks, strokes, pulmonary embolism (PE), and deep vein thrombosis (DVT), as well as cancers such as lymphoma and lung cancer.

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Cancers, Blood Clots, Heart Problems, and Deaths Associated with Xeljanz, Olumiant, and Rinvoq

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We continue to monitor the pharmaceutical regulatory sector as well as the medical literature for developments as regards the increased risks of cancers, blood clots, heart problems, and deaths associated with Xeljanz, Olumiant, and Rinvoq.

In December 2021 there was another JAK inhibitors drug class safety development, with Xeljanz, Olumiant, and Rinvoq getting revised drug labels with more side effects warnings and more drug use restrictions. These December 2021 label changes were “new” but anticipated because back in September 2021 the FDA announced that it was requiring revisions to the “Black-Box” warnings already on the drug labels for Xeljanz, Olumiant, and Rinvoq “to include more information about the risks of serious heart-related events, cancer, blood clots, and death.”

Xeljanz is a Pfizer drug, Rinvoq is an AbbVie drug, and Olumiant is an Eli Lilly drug. The pharmaceutical companies AbbieVie and Eli Lilly have attempted to distinguish the safety profile of their respective JAK inhibitors drug product from the various adverse drug reactions that have been observed in the Xeljanz clinical trial that have driven the FDA regulatory actions driving these December drug label changes.

One pharmaceutical industry commentator wrote after the latest Xeljanz, Olumiant, and Rinvoq label changes said he thinks that AbbVie may have an advantage in “market share” going forward as regards the three JAK inhibitors drugs approved for the treatment of rheumatoid arthritis, given some details of the new drug label for Rinvoq.

Our law firm is investigating possible Xeljanz, Olumiant, and Rinvoq lawsuits for patients who have suffered serious side effects or adverse drug reactions while using one of these JAK inhibitors. In particular, we are reviewing cases of cancers, blood clots, heart problems, and deaths associated with Xeljanz, Olumiant, and Rinvoq.

If we can be of assistance to you or someone you know, please feel free to contact us, at your convenience.

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Olumiant and Those JAK Inhibitors Drug Safety Issues: Eli Lilly’s “Spin”

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Olumiant (baricitinib), Xeljanz (tofacitinib), and Rinvoq (upadacitinib) are the three Janus kinase (JAK) inhibitors currently approved by the FDA for the treatment of arthritis and other inflammatory conditions. In September 2021 the FDA announced a JAK inhibitors drug class label change. Specifically, the FDA is requiring revisions to the “Black-Box” warnings for Olumiant, Xeljanz,  and Rinvoq to include information about the increased risk of serious side effects associated with JAK inhibitors drugs.

Olumiant is an Eli Lilly drug, and this pharmaceutical company is attempting to distinguish the safety profile of their respective JAK inhibitors drug product from the JAK inhibitors drug class safety issues flagged by the FDA.

For example, there is this Lilly News Release document, “OLUMIANT® Long-Term Safety Profile Established Up to 9.3 Years in Integrated Analysis of More Than 3,700 Patients with Rheumatoid Arthritis”, which was issued on November 9, 2021.

For some analysis and context about that November 2021 Olumiant press release from Eli Lilly, we refer you to this Fierce Pharma news report, “Eli Lilly touts long-term safety data for Olumiant amid classwide scrutiny on JAK meds”, published on November 10, 2021.

In the new pooled analysis, the incidence of major adverse cardiovascular events (MACE) for Olumiant was 0.51 per 100 patient-years of exposure, which Lilly said falls within the range in the general rheumatoid arthritis population as described in epidemiological studies….

In a subgroup of patients over 50 years old who had at least one existing heart risk factor, the incidence rate of MACE [for Olumiant] was higher at 0.77 per 100 patient-years.

That latter patient population was targeted in Pfizer’s postmarketing safety study for Xeljanz. As [Pfizer] disclosed earlier this year, Xeljanz’s MACE incidence rate was 0.91 per 100 person-years at the 5 mg dose….

As for the cancer rates, the age-adjusted number for Olumiant was 0.92 per 100 person-years, which Lilly again said appeared similar to the general U.S. population. In the Pfizer trial, Xeljanz recorded a cancer rate of 1.13….

The FDA is still considering the details of the JAK inhibitors drug class “Black-Box” warnings label change it announced in September 2021.

Our law firm is investigating possible drug injury lawsuits for patients who used Olumiant, Rinvoq, or Xeljanz and then suffered serious side effects associated with JAK inhibitors drugs. These include heart problems such as heart attacks, strokes, pulmonary embolism (PE), and deep vein thrombosis (DVT), as well as cancers such as lymphoma and lung cancer.

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Imbruvica Heart-Related Side Effects and Cardiotoxicity Safety Issues

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In this article, we point out a few of the medical news reports about heart-related Imbruvica side effects that have been published in the past 12 months.

First, there is this November 2020 Healio article, “Link between ibrutinib-related hypertension, heart problems necessitates close monitoring”, which provides some key findings from several different medical journal articles about research focused on heart-related Imbruvica side effects. From the Conclusions part of that Healio article:

[Chronic lymphocytic leukemia (CLL)] is a disease of the elderly. Real-world evaluations suggest many patients initiated on [Imbruvica (ibrutinib)] have significant comorbidities, many of them cardiovascular.

Hypertension — an important risk factor for the development of atrial fibrillation — may occur at a much higher rate in real-world practice settings than reported in clinical trials.

Patients should be monitored for the development of new or worsened hypertension, particularly early in the therapy course.

Second, we have a June 2021 report from ThePharmaLetter, “Imbruvica: new safety signal for use with rituximab and ACE inhibitors” about the European Medicines Agency (EMA) issuing a new safety signal for Imbruvica with rituximab:

As part of its advice on safety-related aspects to other European Medicines Agency committees, the Pharmacovigilance Risk Assessment Committee (PRAC) last week discussed a direct healthcare professional communication (DHPC) containing important safety information for Imbruvica (ibrutinib).

This DHPC aims to inform healthcare professionals about a new safety signal of sudden or cardiac death with Imbruvica when used in combination with rituximab and angiotensin-converting enzyme (ACE) inhibitors. The signal was recognized following a review of the findings of a clinical trial….

Third, and most recent, is a September 2021 MedPage Today news report, “Ibrutinib for CLL Tied to Higher Heart Risks vs Chemotherapy”, about there being increased risks for atrial fibrillation, bleeding, and heart failure seen in a Canadian cohort of patients using Imbruvica:

Use of the Bruton tyrosine kinase (BTK) inhibitor ibrutinib (Imbruvica) was linked with cardiovascular risks in patients with chronic lymphocytic leukemia (CLL), according to results of a population-based cohort study.

Over 3 years, the incidence of atrial fibrillation (AF)-related healthcare contact was 22.7% in patients treated with [Imbruvica (ibrutinib)] compared with 11.7% in patients who received chemotherapy, risk of hospital-diagnosed bleeding was 8.8% and 3.1%, respectively, and risk of heart failure (HF) was 7.7% and 3.6%, reported Husam Abdel-Qadir, MD, PhD, of Women’s College Hospital in Toronto, and colleagues.

We will continue to monitor the medical literature for more reports of heart-related Imbruvica side effects, as well as watch for possible regulatory action by the FDA or the EMA.

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FDA Advisory Committee Meeting Could Review Risk/Benefit Profiles for All JAK Inhibitors

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The FDA has delayed its decision for Abbvie’s applications to have Rinvoq approved for the additional indications of psoriatic arthritis and ankylosing spondylitis, apparently due to possible new JAK inhibitors heart side effects and cancer risks issues identified in connection with a Xeljanz safety signal.

From this June 25, 2021, FiercePharma news report, “AbbVie’s big Rinvoq ambitions — and the larger JAK class — face even more uncertainty with latest FDA delays”, we get the following:

In postponing Rinvoq, the FDA said it’s still reviewing those Pfizer data, according to AbbVie. In February, the agency alerted patients and doctors of Xeljanz’s safety signal. At that time, it said it would dig into the results and consider what moves to take.

Existing JAK inhibitors, including Rinvoq, already bear warnings of increased risk of blood clots on their U.S. labels. Xeljanz’s cardiovascular red flag obviously made the FDA nervous about it being a class-wide problem for all JAK drugs.

For some additional perspective, we turn to this June 25, 2021, EndpointNews article, “FDA pushes back decisions on AbbVie’s Rinvoq sNDAs to further review a failed Pfizer trial”:

The regulator’s continued evaluation of the Pfizer trial shows those safety concerns have not abated. Pfizer announced in January that ORAL Surveillance, its six-year post-marketing trial for its JAK inhibitor Xeljanz, had failed. Across 4,362 patients, those who received either a low or high dose of Xeljanz experienced more major cardiovascular events — such as stroke and heart attack — than those on Humira or Enbrel. They also had higher rates of cancer, with Pfizer failing to hit non-inferiority on both primary endpoints.

We will continue to watch for further developments and indications concerning an FDA Advisory Committee for Xeljanz, Rinvoq, and other JAK inhibitors so that outside experts to review their risk/benefit profiles as regards new indications such as atopic dermatitis. If this comes to be, we expect that FDA Advisory Committee would be discussing the new JAK inhibitors heart side effects and cancer risks issues which were flagged by means of the earlier Xeljanz safety signal.

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Possible FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq in Future

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Based on these several recent developments, we expect that there will be an FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq in the months to come. The focus of such will likely be these adverse drug events and side effects related to the JAK inhibitors class of drugs:

Heart Attacks
Myocardial Infarction (MI)
Strokes — Ischemic / due to a blood clot
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Arterial Thrombosis
Cancers
Death

Last week we saw this April 8, 2021, Endpoints News article with a telling headline, “Series of JAK inhibitor delays may signal an upcoming FDA adcomm”, by Zachary Brennan, from which we get the following insights:

Three-month review delays from the FDA have become the norm in recent days for JAK inhibitors, some of which are seeking label expansions.

But the pushback of these action dates for AbbVie’s Rinvoq, Pfizer’s Xeljanz and abrocitinib, and Eli Lilly’s Olumiant may be a sign that the FDA is preparing to hold an advisory committee of outside experts to review the risk/benefit profiles of JAK inhibitors for atopic dermatitis, according to Leerink analyst Geoffrey Porges. This wouldn’t be the first time this year that the FDA wants to review a series of drugs before an adcomm as the agency is holding such a review later this month for cancer drugs that have previously won accelerated approvals.

We will continue to watch for new information about an increased risk of serious heart-related problems and cancer associated with Xeljanz. And we will look for any related developments concerning the JAK inhibitors class of drugs, such as the possible FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq mentioned above.

At the present time, our law firm is investigating possible Xeljanz drug injury lawsuits for people who have been diagnosed with heart-related problems or cancer.

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Are Heart Problems and Cancers JAK Inhibitors Drug Class Safety Issues?

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Since the February 2021 FDA alert about Xeljanz-associated heart problems and possible Xeljanz-related cancers was issued, we have been watching for any related drug safety developments concerning Olumiant and Rinvoq. The reason being there has been some concern that those adverse drug events and side effects risks may apply to those other two Janus kinase (JAK) inhibitors, also. Put otherwise, are heart problems and cancers to be viewed as JAK inhibitors drug class safety issues?

One indication of this concern is found in a March 18, 2021, BioPharma news report, “AbbVie’s approval delay raises further concerns about JAK drugs”, from which we get the following:

The Food and Drug Administration may take up to three months longer to review an application from AbbVie to get Rinvoq, its marketed medicine for rheumatoid arthritis, also approved to treat active psoriatic arthritis. The company now expects a decision toward the end of the second quarter.

AbbVie gave few details about the reasons for the delay in a Wednesday statement, noting only that the FDA had requested new information on the drug’s benefits and risks in psoriatic arthritis patients. But after speaking with the company, Vamil Divan, an analyst at Mizuho Securities, learned the requests were for long-term safety data similar to what Pfizer recently showed for Xeljanz, a rival drug that works like Rinvoq.

We will continue to watch for newly released information from the Xeljanz safety clinical trial that showed Xeljanz-associated heart problems and possible Xeljanz-related cancers and which is the basis for the February 2021 Xeljanz FDA Drug Safety Communication. In addition, for the reasons stated above, we will monitor the safety profile of Rinvoq and Olumiant to see whether those are JAK inhibitors drug class adverse drug events and side effects risks.

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New Xeljanz Warnings From FDA in 2021; Are Other JAK Inhibitors Next?

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After the January 2021 release of limited data from a Xeljanz safety trial which often goes by its short name, ORAL Surveillance, some experts raised the possibility that there may consequences for other drugs in the Janus kinase (JAK) inhibitors class of drugs. Specifically, some have asked whether the FDA may extend its new Xeljanz warnings about Xeljanz causing heart problems and Xeljanz causing cancer to those other drugs.

Besides Xeljanz, there are two other JAK inhibitors approved by the FDA:

  • Olumiant (baricitinib) from Eli Lilly & Co.; and,
  • Rinvoq (upadacitinib) from AbbVie.

This February 4, 2021, FDA Drug Safety Communication, “Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)”, announce the new Xeljanz warnings. It is the ORAL Surveillance Xeljanz safety trial data that is the basis for those new Xeljanz warnings as well as some Xeljanz drug safety alerts issued by the FDA during the past few years.

For some commentary on this Xeljanz safety trial, which started in March 2104 and was completed in July 2020, we go to this February 16, 2021, Healio Rheumatology article, “‘We need to see the data’: FDA’s Xeljanz safety warning stirs concerns for JAK inhibitors”:

[Stanley Cohen, MD, clinical professor in the department of internal medicine at the University of Texas Southwestern Medical School, and medical codirector of the Metroplex Clinical Research Center, told Healio Rheumatology] the fact that ORAL Surveillance was a head-to-head trial suggests there is “certainly a signal” for major cardiovascular events and cancer with [Xeljanz (tofacitinib)].

“I do think these results are serious,” Cohen said. “I think it’s something we have to look at critically, and again, with just the topline — what can you say? We need to look at all the data and better understand the data.

As mentioned above, the February 2021 FDA safety alert about Xeljanz having increased risks for serious heart-related problems and cancers raises the issue of whether all JAK inhibitors share these side effect risks:

According to Cohen, Pfizer’s results with Xeljanz indicate that other companies that produce JAK inhibitors should likely go back and examine their clinical trial programs, selecting out those patients with the same risk factors to see if there was any imbalance in MACE or malignancies.

As such, besides just watching for more data from the Xeljanz safety trial showing an increased risk of serious heart-related problems and cancer associated with Xeljanz, we will look for any indication that the new Xeljanz warnings might be added to Olumiant and Rinvoq, also.

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Xeljanz 2021 FDA Warnings: Xeljanz Causing Heart Problems and Xeljanz Causing Cancer

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The Xeljanz safety issues of Xeljanz causing heart problems and Xeljanz causing cancer were already “highlighted” by means of the Xeljanz Black Box Warning added back in 2019. But in February 2021 the FDA pointed out these Xeljanz side effects again in this FDA Drug Safety Communication, “Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)”.

As to what the FDA did not say in that 2021 Xeljanz FDA Drug Safety Communication — but what seems to be indicated by this latest Xeljanz FDA action — we refer you to this February 4, 2021, MedPage Today news report, “No Xeljanz Plan Yet From FDA”:

But the FDA is not yet prepared to take action, which could include ordering new label language, requiring a risk evaluation and mitigation strategy (REMS), or even pulling the drug from the market.

For the time being, at least, it appears that Pfizer is not inclined to withdraw Xeljanz from the market given that there was a Xeljanz television advertisement that ran in my part of the country during the national nightly news a couple of days after this “new” 2021 FDA drug safety alert about Xeljanz side effects was issued.

One wonders how the FDA might react to this “direct to consumer” advertisement for Xeljanz which Pfizer was still running after the February 2021 FDA Xeljanz Drug Safety Communication about Xeljanz causing heart problems and Xeljanz causing cancer.

It seems within the realm of possibility that the FDA may mandate a Xeljanz recall in the future, but this remains to be seen.

Of course, we will be vigilant as, with the FDA, we wait for “further information” from the safety clinical trial showing an increased risk of serious heart-related problems and cancer associated with Xeljanz.

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