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Growing Awareness about Testosterone Replacement Therapy to Drive Market

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North America to Dominate Global Market

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Testosterone Replacement Therapy Market: Rise in Geriatric Population with High Risk of Testosterone Deficiency Boost Market Growth - BioSpace

Based on emerging evidence and expert consensus, a panel assembled by the American College of Rheumatology (ACR) released recommendations for the management of reproductive health in patients with rheumatic and musculoskeletal diseases (RMD). This report was published in Arthritis & Rheumatology.

Investigators performed a systematic review of studies relating to contraception, assisted reproductive technologies, fertility preservation, menopausal hormone therapy, pregnancy and lactation, and medication use in patients with RMD. They developed recommendations using Grading of Recommendations Assessment, Development, and Evaluation methodology to rate evidence quality.

Recommendations for Contraception

The ACR strongly recommends the use of effective contraceptives, including hormonal contraceptives and intrauterine devices (IUDs), over no contraception in reproductive-age women with RMD without systemic lupus erythematosus (SLE) or antiphospholipid antibodies (aPLs). Long-acting reversible contraceptives such as IUDs or subdermal progestin implants are encouraged as first-line contraceptive methods because of their real-world effectiveness. The use of emergency contraception should be discussed with all patients because the risk for unplanned pregnancy in RMD outweighs the risk related to emergency contraception.

Patients With SLE

In patients with SLE with low or stable disease activity and who are not aPL-positive, the panel recommends the use of effective contraceptives over no contraception and encourages the use of highly effective IUDs or subdermal progestin implants as first-line contraceptive methods. However, the ACR recommends against the use of the transdermal estrogen-progestin patch as it results in greater estrogen exposure compared with oral or transvaginal methods, which potentially increase risk for flare or thrombosis.

In patients with SLE with moderate or severe disease activity, progestin-only or IUD contraception is recommended over combined estrogen-progestin contraceptive methods, as the latter has not been studied in this patient population.

aPL-Positive Patients

In aPL-positive women, the panel strongly recommends IUDs (levonorgestrel or copper) or the progestin-only pill and recommends against combined estrogen-progestin contraception because estrogen increases the risk for thromboembolism.

Other RMD Situations

In women with RMD who are receiving immune-suppressive therapy, copper or progestin IUDs are recommended as the most effective contraceptive option.

In women at risk for osteoporosis from glucocorticoid use or underlying disease, the ACR recommends against using depot medroxyprogesterone acetate (DMPA) injections as long-term contraception because DMPA is associated with declines in bone mineral density and fracture risk.

In women with RMD taking mycophenolate mofetil/mycophenolic acid, an IUD alone or 2 other contraceptive methods used together are suggested, as mycophenolate mofetil may reduce estrogen and progesterone levels and hence reduce the efficacy of oral contraceptives.

Recommendations for Assisted Reproductive Technology

The ACR strongly recommends women with uncomplicated RMD (stable/quiescent disease activity and without aPLs) who are receiving pregnancy-compatible medications proceed with assisted reproductive technology. However, rheumatologists should discuss with their patients the risks associated with assisted reproductive technology, especially lupus flare and thrombosis.

Patients With SLE

In patients with RMD who experience moderate to severe disease activity, assisted reproductive technology procedures should be deferred, as RMD disease activity may increase pregnancy-associated risks.

In women with SLE undergoing assisted reproductive technology procedures, the panel recommends against an empiric dosage increase of prednisone and recommends monitoring the patient carefully and treating a flare if it occurs.

aPL-Positive Patients

The ARC recommends assisted reproductive technologies with anticoagulation therapy in patients with RMD and stable/quiescent disease activity and who have asymptomatic positive aPLs, obstetric antiphospholipid syndrome, or treated thrombotic antiphospholipid syndrome.

Use of prophylactic anticoagulation therapy with heparin or low-molecular-weight heparin are strongly suggested for women with RMD undergoing assisted reproductive technology procedures who report asymptomatic positive aPLs or obstetric or treated thrombotic antiphospholipid syndrome.

Embryo and Oocyte Cryopreservation

Continuation of necessary immunosuppressive and/or biologic therapies (other than cyclophosphamide) are strongly encouraged in patients with stable disease activity who undergo ovarian stimulation for the purpose of oocyte retrieval or embryo cryopreservation.

Recommendations for Fertility Preservation

The ACR recommends monthly gonadotropin-releasing hormone agonist co-therapy to prevent primary ovarian insufficiency in premenopausal women with RMD who receive a monthly intravenous cyclophosphamide dose. However, men with RMD who receive cyclophosphamide should not receive testosterone co-therapy, as it does not help preserve fertility in men. Sperm cryopreservation is a strongly suggested practice for men before being treated with cyclophosphamide.

Recommendations for Menopause and Hormone Replacement Therapy

Hormone replacement therapy is strongly suggested in postmenopausal women with RMD without SLE or positive aPLs. In patients with SLE without positive aPLs, hormone replacement therapy is recommended conditionally because a small increase in risk for mild to moderate lupus flares is associated with oral hormone replacement therapy.

Hormone replacement therapy is not recommended in women with asymptomatic aPLs, or obstetric or thrombotic antiphospholipid syndrome. Furthermore, patients receiving anticoagulation treatment for antiphospholipid syndrome even patients who are negative for aPL should not use hormone replacement therapy.

In patients with a history of positive aPLs but who currently test negative for aPL and have no history of clinical antiphospholipid syndrome, hormone replacement therapy may be considered if desired.

Recommendations for Pregnancy

The ACR strongly suggests counseling women with RMD who are considering pregnancy, in which improved maternal and fetal outcomes have been associated with entering pregnancy with quiescent or low disease activity. Maintaining concurrent care with obstetricians-gynecologists, neonatologists, and other appropriate specialists is recommended as good practice.

Women with RMDs planning pregnancy should switch to pregnancy-compatible medications with enough time to assess efficacy and tolerability of the new medication.

For women with RMD who are currently pregnant and whose active disease requires continuous medication, pregnancy-compatible steroid-sparing treatment is strongly recommended, as high-dose glucocorticoids can potentially cause maternal or fetal harm.

Patients With SLE

Women with SLE or similar disorders (Sjgren syndrome, systemic sclerosis, rheumatoid arthritis) should be tested for anti-Sjgren syndrome-related antigen A (RO/SSA) and anti-Sjgren syndrome-related antigen B (La/SSB) antibodies in early pregnancy. However, because of the antibodies relative persistence, repeat testing during pregnancy is not needed.

In pregnant patients with active scleroderma renal crisis, the ACR strongly recommends the use of angiotensin-converting enzyme inhibitor or angiotensin receptor blockade therapy because the risk for maternal or fetal death outweighs the risk associated with these medications.

The ACR strongly suggests that pregnant women with SLE be closely monitored with clinical history, examination, and laboratory tests at least once per trimester as disease activity can affect pregnancy outcomes. If possible, all women with SLE should take hydroxychloroquine during pregnancy. Pregnant patients with SLE are also recommended to begin a daily low-dose aspirin (81 mg or 100 mg) regimen during their first trimester.

aPL-Positive Patients

Pregnant women with positive aPLs (but who do not meet criteria for obstetric or thrombotic antiphospholipid syndrome) should be treated with daily prophylactic aspirin; however, these women are advised against the combined use of aspirin and prophylactic-dose heparin as well as prophylactic hydroxychloroquine treatments.

In women who meet the criteria for obstetric antiphospholipid syndrome, the ACR strongly recommends a combined low-dose aspirin and prophylactic-dose heparin. Furthermore, these patients should be treated with prophylactic-dose anticoagulation for 6 to 12 weeks postpartum.

In women who meet the criteria for thrombotic antiphospholipid syndrome, a regimen of low-dose aspirin and therapeutic-dose heparin is strongly recommended throughout pregnancy and postpartum.

The ACR recommends against treatment with intravenous immunoglobulin or increased low-molecular-weight heparin doses. The panel also recommends against the addition of prednisone to a low-dose aspirin/prophylactic-dose heparin combination; however, the addition of hydroxychloroquine therapy to low-dose aspirin/prophylactic-dose heparin is conditionally recommended.

Anti-Ro/SSA or Anti-La/SSB Antibodies

Serial fetal echocardiography is recommended in pregnant women with anti-Ro/SSA or anti-La/SSB antibodies and should be performed starting between 16 and 18 weeks and continue through week 26. In women with a history of having an infant with complete heart block or neonatal lupus erythematosus, fetal echocardiography is recommended weekly during this time period.

If fetal first- or second-degree heart block is shown on echocardiography, daily treatment with oral dexamethasone (4 mg) is recommended; however, if a complete heart block without cardiac inflammation is shown on echocardiography, then the panel recommends against dexamethasone treatment.

All women who are positive for anti-Ro/SSA or anti-La/SSB antibodies should be treated with hydroxychloroquine during pregnancy, as hydroxychloroquine is associated with lowering risk for the fetus developing complete heart block.

Recommendations for Medication Use

Paternal Medication Use

In men with RMD planning to father a pregnancy, the panel recommends against the use of cyclophosphamide and thalidomide before attempting conception; however, continuation of hydroxychloroquine, azathioprine, 6-mercaptopurine, colchicine, and tumor necrosis factor (TNF) inhibitors are strongly recommended.

Continuation of methotrexate, mycophenolate mofetil, leflunomide, sulfasalazine, calcineurin inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs) is conditionally recommended on the basis of limited evidence, as is the use of anakinra and rituximab.

Maternal Medication Use

The ACR recommends discussing medication use in women with RMD well before attempting conception as standard good practice. The panel further suggests discussing pregnancy plans before initiating treatment with medications that affect gonadal function.

Discontinuation of methotrexate, mycophenolate mofetil, and thalidomide is strongly recommended within 3 months before attempting conception, as these medications are known teratogens, or agents that disrupt fetal development. Cholestyramine washout is recommended for women treated with leflunomide before pregnancy or as soon as pregnancy is confirmed, as detectable serum levels of metabolite risk pregnancy loss and birth defects. If life-threatening conditions occur in the second or third trimester, the panel recommends treatment with cyclophosphamide.

An observation period without medication or transition to pregnancy-compatible medication is recommended to ensure disease stability. In women with exposure to teratogenic medications during or shortly before pregnancy, the panel recommends immediate referral to the appropriate specialist or genetic counselor.

Compatible pregnancy medications commonly recommended for use in patients with RMD include hydroxychloroquine, azathioprine/6-mercaptopurine, colchicine, and sulfasalazine. Calcineurin inhibitors (tacrolimus and cyclosporine) and NSAIDs are also considered compatible with pregnancy; nonselective NSAIDs are recommended over cyclooxygenase 2-specific inhibitors during the first 2 trimesters.

If the patient is having difficulty conceiving, the panel recommends discontinuing use of NSAIDs because of the possibility of NSAID-induced unruptured follicle syndrome. NSAID use should also be discontinued in the third semester to avoid risk for premature closure of the ductus arteriosus.

If indicated, the ACR recommends continuing low-dose glucocorticoid treatments (10 mg daily of prednisone or nonfluorinated equivalent) during pregnancy. Higher doses of nonfluorinated glucocorticoids should be tapered, and a pregnancy-compatible glucocorticoid-sparing agent should be added if necessary. Administration of stress-dose glucocorticoids during vaginal delivery is not recommended; however, such treatment may be indicated during cesarean delivery.

TNF inhibitor therapy with infliximab, etanercept, adalimumab, or golimumab may be continued before and during pregnancy, as these therapies have minimal placental transfer and fetal exposure. Similarly, continuation of certolizumab therapy is strongly recommended.

The panel recommends women continue treatment with anakinra, belimumab, abatacept, tocilizumab, secukinumab, and ustekinumab while attempting conception but should discontinue use once pregnancy is confirmed. Women may continue rituximab treatment while trying to conceive and if life-threatening or organ-threatening maternal disease warrant use during pregnancy.

Medication Use During Breastfeeding

Women with RMD are encouraged to breastfeed if they desire and are able to do so, and the ACR recommends lactation-compatible medications in order to control disease. Hydroxychloroquine, sulfasalazine, rituximab, and TNF inhibitors are strongly recommended as compatible with breastfeeding. A prednisone daily dose <20 mg is also compatible with breastfeeding; however, women who use prednisone doses 20 mg are recommended to delay breastfeeding or discard breast milk accumulated in 4 hours after administration.

Treatment with azathioprine/6-mercaptopurine, calcineurin inhibitors, NSAIDS, and non-TNF inhibitor biologics (anakinra, rituximab, belimumab, abatacept, tocilizumab, secukinumab, and ustekinumab) is conditionally recommended during breastfeeding.

The panel recommends against the use of cyclophosphamide, leflunomide, mycophenolate mofetil, thalidomide, and methotrexate while breastfeeding.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors disclosures.

Reference

Sammaritano LR, Bermas BL, Chakravarty EE, et al. 2020 American College of Rheumatology Guideline for the management of reproductive health in rheumatic and musculoskeletal diseases [published online February 23, 2020]. Arthritis Rheumatol. doi:10.1002/art.41191

Read the original here:
ACR Recommendations for Managing Reproductive Health in Rheumatic and Musculoskeletal Diseases - Rheumatology Advisor

Lindsay Hecox was looking forward to finally running track in college. Hecox, a 19-year-old freshman at Boise State University, ran cross country in high school and said it was the only place where she felt like she could be herself. In addition to describing herself as a shy introvert, Hecox has attention deficit hyperactivity disorder, which made it difficult to make friends. Running provided her a shared experience to bond with her classmates.

Even though I definitely wasn't the most social, I still felt accepted, Hecox told VICE. I was a pretty good runner and everyone likes you if youre nice and you can run fast.

Hecox, who came out as transgender at the end of her senior year of high school, took the year off from running competitively to start transitioning and focus on her studies. Guidelines established by the NCAA state that trans female athletes must take medications that suppress their testosterone levels for a year before they are allowed to compete, and she started hormone replacement therapy last September. That means she could have been eligible for the 2020-2021 school year. (The NCAA told The Hill last month that it was monitoring the bills progress.)

If she had made the team, Hecox would have made history: No transgender student athlete has ever competed openly on a collegiate track team in Idaho. Hecox said she wasnt looking to break records, though. She just wanted to feel at home again.

Running really helps stabilize me, as I sometimes have mood fluctuations, Hecox said. If I go out for a run, it cleans the slate, and I feel like I can release a little bit of stress after that. If you have a friend and youre running alongside them, it feels like youre losing track of time and it gets your mind off things, as you just look forward to the next mile marker.

But Hecox could soon be banned from the sport she loves if Idaho signs a bill into law that would prohibit transgender women and girls from participating in school athletics in alignment with their gender identity. House Bill 500, also known as the Fairness in Womens Sports Act, applies to student-athletes playing in K-12 sports and at the collegiate level, no matter if the university is public or private. The legislation is headed to Gov. Brad Littles desk after passing the Idaho Senate last Monday by a 24-11 vote and the House last month, both of which are dominated by Republicans.

HB 500 isnt the only anti-trans bill awaiting the governors proverbial pen. Just days after the Senate overwhelmingly approved the trans sports ban, it also passed House Bill 509, which prevents transgender people from updating their birth certificates to match their lived gender. In a Thursday vote, all but six Senators approved the legislation, also called the Idaho Vital Statistics Act.

Little has yet to state whether he intends to support either of the two proposals, but when asked about them last month, the governor was quoted in the Idaho Press as saying hes not a big discrimination guy.

The bills have been met with virulent opposition from civil rights groups. Kathy Griesmyer, policy director for the American Civil Liberties Union of Idaho, said their passage would set a really dangerous precedent that would likely be used as a model for discriminating against transgender people in other states. Although the ACLU estimated that 17 states in the U.S. have introduced bills in the 2020 legislative session that would restrict the ability of trans students to compete in school sports, none have passed. HB 500 would be the first bill of its kind in the nation.

There are really devastating consequences if HB 500 becomes law, Griesmyer told VICE. This has the potential to harm intersex people, women who present too masculine, or anybody who wants to use this law to go after a competitor.

Among the most glaring issues with HB 500 is that it stipulates that a student athletes biological sex would have to be determined by one of three factors before they are allowed to compete. These options are a test of the individuals internal and external reproductive anatomy, normal endogenously produced levels of testosterone, or genetic makeup.

But as in the case of a similar bill introduced in Arizona, the legislation does not establish a process for bringing about these claims, meaning that any student or their parent could accuse an athlete on an opposing team of being transgender. Accused students, many of whom as likely to be cisgender, would thereby be forced to undergo costly DNA testing or an invasive genital exam. The proposal also does not state what body would be responsible for looking into complaints or how a students private medical information would be protected.

Notably, the Arizona bill was watered down to remove the genital testing components following public backlash. The Idaho legislation has remained unchanged, despite the concerns of LGBTQ advocacy groups.

This bill is not based on science, Kate Oakley, senior counsel for the Human Rights Campaign, told VICE. It is legislation that is based purely in misinformation about trans youth, and it is targeting trans youth for discriminatory treatment. For any trans person in Idaho, they are now on notice that their government is willing to make laws that are based on fear and not facts.

The anti-trans bills are likely to be met with immediate legal action should they be signed into law, as five former Idaho attorneys general argued in a March 17 letter addressed to Little. In particular, critics said HB 509, the birth certificate bill, would violate a court order from U.S. District Court Magistrate Judge Candy W. Dale, who ruled in March 2018 that Idahos policy of denying birth certificate corrections on the basis of gender identity was unconstitutional. Prior to that time, Idaho was one of three statesalong with Ohio and Tennesseethat did not allow trans people to update their birth records.

When that policy was overturned in district court, Emilie Jackson-Edney was one of the first people in Idaho to apply for a corrected birth certificate. Jackson-Edney, who sits on the board of the Pride Foundation in Boise, said she had started her application process eight years earlier but that the long wait was worth it.

Its necessary to navigate safely through society with minimal harassment and minimal scrutiny, Jackson-Edney told VICE, noting that a third of trans people without a corrected birth certificate report experiencing mistreatment and even physical violence as a result. Its a safety issue. For trans people having concurrent identity documents that reflect their gender identity is really critical, and not being able to have them would be very difficult.

What makes these bills particularly hurtful for trans people in Idaho is the timing of the legislation. They were pushed through the state Senate during the same week that municipalities across the country took measures to curb the spread of coronavirus, also known as COVID-19. And yet in Idaho, little has been done to stop its citizens from contracting coronavirus.

I havent seen one thing from the [state] government other than telling us to wash our hands, and I honestly don't think that were taking it very seriously, said Yarit Rodriguez, who runs a support group for trans youth in Idaho, told VICE. He added that it doesn't make sense to him why passing anti-trans bills is more important than an outbreak affecting multiple communities.

The lack of statewide action on coronavirus is particularly personal for Hecox, who was being forced out of her dorm at Boise State as she spoke over the phone on Thursday. The university sent an email to students earlier the same day ordering anyone who hadnt already abandoned campus housing to evacuate the premises within the week. Although many students who have family in the area have the option to simply move back home, it wasnt so easy for her.

I was living with my grandparents in California before, she said. They don't want another person living with them because of their age. They are susceptible to having a bad reaction to the virus or dying.

To keep Hecox from being homeless, her mother is uprooting her life in California to move to Boise. Even as the federal government debates a trillion-dollar stimulus package that would provide greater assistance to families like hers, which have been forced into impossible situations, Hecox noted that Idaho lawmakers had yet to make any similar moves. The Senate wrapped for the year on Thursday, while the House finished up the following day.

They have not passed any legislation for that, she said of a statewide coronavirus relief effort. They dont have their priorities straight.

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Everyone Else Is Dealing with COVID-19. Idahos Pushing an Anti-Trans Bill - VICE