Key clinical point: Preventive monitoring for cardiovascular risk is suggested in tofacitinib-treated patients with psoriatic arthritis (PsA) as higher atherosclerotic cardiovascular disease (ASCVD) risk appears to be associated with a higher incidence of major cardiovascular events (MACE) and malignancies.

Major finding: The risk for MACE appeared to be higher among patients with PsA and high vs low 10-year ASCVD risk (incidence rate [IR] 1.37 [95% CI 0.03-7.63] vs 0.08 [95% CI 0.0-0.42]), with the incidence of malignancies being the highest in patients with PsA and an intermediate 10-year ASCVD risk (IR 2.56, 95% CI 1.11-5.05).

Study details: Findings are from a post hoc analysis of 10 clinical trials including patients with PsA (n = 783) and psoriasis (n = 3663) who received tofacitinib.

Disclosures: This study was sponsored by Pfizer. Some authors declared receiving speaker fees or grant or research support or serving as consultants for various sources, including Pfizer. Some authors declared being employees and shareholders of Pfizer or Syneos Health, a paid contractor to Pfizer.

Source: Kristensen LE et al. Association between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib. Ther Adv Musculoskelet Dis. 2023 (Feb 7). Doi: 10.1177/1759720X221149965

Key clinical point: Preventive monitoring for cardiovascular risk is suggested in tofacitinib-treated patients with psoriatic arthritis (PsA) as higher atherosclerotic cardiovascular disease (ASCVD) risk appears to be associated with a higher incidence of major cardiovascular events (MACE) and malignancies.

Major finding: The risk for MACE appeared to be higher among patients with PsA and high vs low 10-year ASCVD risk (incidence rate [IR] 1.37 [95% CI 0.03-7.63] vs 0.08 [95% CI 0.0-0.42]), with the incidence of malignancies being the highest in patients with PsA and an intermediate 10-year ASCVD risk (IR 2.56, 95% CI 1.11-5.05).

Study details: Findings are from a post hoc analysis of 10 clinical trials including patients with PsA (n = 783) and psoriasis (n = 3663) who received tofacitinib.

Disclosures: This study was sponsored by Pfizer. Some authors declared receiving speaker fees or grant or research support or serving as consultants for various sources, including Pfizer. Some authors declared being employees and shareholders of Pfizer or Syneos Health, a paid contractor to Pfizer.

Source: Kristensen LE et al. Association between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib. Ther Adv Musculoskelet Dis. 2023 (Feb 7). Doi: 10.1177/1759720X221149965

Key clinical point: Preventive monitoring for cardiovascular risk is suggested in tofacitinib-treated patients with psoriatic arthritis (PsA) as higher atherosclerotic cardiovascular disease (ASCVD) risk appears to be associated with a higher incidence of major cardiovascular events (MACE) and malignancies.

Major finding: The risk for MACE appeared to be higher among patients with PsA and high vs low 10-year ASCVD risk (incidence rate [IR] 1.37 [95% CI 0.03-7.63] vs 0.08 [95% CI 0.0-0.42]), with the incidence of malignancies being the highest in patients with PsA and an intermediate 10-year ASCVD risk (IR 2.56, 95% CI 1.11-5.05).

Study details: Findings are from a post hoc analysis of 10 clinical trials including patients with PsA (n = 783) and psoriasis (n = 3663) who received tofacitinib.

Disclosures: This study was sponsored by Pfizer. Some authors declared receiving speaker fees or grant or research support or serving as consultants for various sources, including Pfizer. Some authors declared being employees and shareholders of Pfizer or Syneos Health, a paid contractor to Pfizer.

Source: Kristensen LE et al. Association between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib. Ther Adv Musculoskelet Dis. 2023 (Feb 7). Doi: 10.1177/1759720X221149965

Key clinical point: Signatures of circulating microRNA in patients with psoriatic arthritis (PsA) and patients with psoriasis were significantly different from those in control individuals, with some even being differentially regulated between PsA and psoriasis.

Major finding: Overall, 9 microRNA best differentiated patients with PsA and psoriasis from control individuals (area under the curve [AUC] ≥0.70; all P < .05) and 4 microRNA best differentiated patients with PsA from patients with psoriasis (all P < .05). A combination of 4 microRNA (miR-19b-3p, miR-21-5p, miR-92a-3p, and let-7b-5p) vs miR-92a-3p alone could better differentiate between patients with PsA and psoriasis (AUC 0.92 vs 0.82).

Study details: This cross-sectional study included 51 patients with PsA, 40 patients with psoriasis, and 50 control individuals.

Disclosures: This study did not receive any specific funding. Two authors declared being employees or shareholders of TAmiRNA GmbH or holding intellectual property for the diagnostic use of microRNA in bone diseases.

Source: Haschka J et al. Identification of circulating microRNA patterns in patients in psoriasis and psoriatic arthritis. Rheumatology (Oxford). 2023 (Feb 3). Doi: 10.1093/rheumatology/kead059

Key clinical point: Signatures of circulating microRNA in patients with psoriatic arthritis (PsA) and patients with psoriasis were significantly different from those in control individuals, with some even being differentially regulated between PsA and psoriasis.

Major finding: Overall, 9 microRNA best differentiated patients with PsA and psoriasis from control individuals (area under the curve [AUC] ≥0.70; all P < .05) and 4 microRNA best differentiated patients with PsA from patients with psoriasis (all P < .05). A combination of 4 microRNA (miR-19b-3p, miR-21-5p, miR-92a-3p, and let-7b-5p) vs miR-92a-3p alone could better differentiate between patients with PsA and psoriasis (AUC 0.92 vs 0.82).

Study details: This cross-sectional study included 51 patients with PsA, 40 patients with psoriasis, and 50 control individuals.

Disclosures: This study did not receive any specific funding. Two authors declared being employees or shareholders of TAmiRNA GmbH or holding intellectual property for the diagnostic use of microRNA in bone diseases.

Source: Haschka J et al. Identification of circulating microRNA patterns in patients in psoriasis and psoriatic arthritis. Rheumatology (Oxford). 2023 (Feb 3). Doi: 10.1093/rheumatology/kead059

Key clinical point: Signatures of circulating microRNA in patients with psoriatic arthritis (PsA) and patients with psoriasis were significantly different from those in control individuals, with some even being differentially regulated between PsA and psoriasis.

Major finding: Overall, 9 microRNA best differentiated patients with PsA and psoriasis from control individuals (area under the curve [AUC] ≥0.70; all P < .05) and 4 microRNA best differentiated patients with PsA from patients with psoriasis (all P < .05). A combination of 4 microRNA (miR-19b-3p, miR-21-5p, miR-92a-3p, and let-7b-5p) vs miR-92a-3p alone could better differentiate between patients with PsA and psoriasis (AUC 0.92 vs 0.82).

Study details: This cross-sectional study included 51 patients with PsA, 40 patients with psoriasis, and 50 control individuals.

Disclosures: This study did not receive any specific funding. Two authors declared being employees or shareholders of TAmiRNA GmbH or holding intellectual property for the diagnostic use of microRNA in bone diseases.

Source: Haschka J et al. Identification of circulating microRNA patterns in patients in psoriasis and psoriatic arthritis. Rheumatology (Oxford). 2023 (Feb 3). Doi: 10.1093/rheumatology/kead059

Key clinical point: The crude mortality rate increased by two-fold in patients with psoriatic arthritis (PsA) during the COVID-19 pandemic compared with the pre-pandemic era, with pulmonary reasons being the major risk factors for mortality.

Major finding: Although standard mortality rates were similar between patients with PsA and the general population during the pre-pandemic period (0.95; 95% CI 0.61-1.49), the crude mortality rate, which was 5.07 before the pandemic, increased by 2.12-fold during the pandemic in the PsA population. Interestingly, deaths due to pulmonary reasons increased from 6% during the pre-pandemic era to 66% during the pandemic.

Study details: Findings are from an international multicenter registry study including 1216 patients with PsA who were followed up for 7500 patient-years.

Disclosures: This study did not report the source of funding. Some authors declared receiving honoraria or research grants from several sources.

Source: Erden A et al. Mortality in psoriatic arthritis patients, changes over time, and the impact of COVID-19: Results from a multicenter Psoriatic Arthritis Registry (PsART-ID). Clin Rheumatol. 2023;42(2):385-390(Jan 13). Doi: 10.1007/s10067-022-06492-6

Key clinical point: The crude mortality rate increased by two-fold in patients with psoriatic arthritis (PsA) during the COVID-19 pandemic compared with the pre-pandemic era, with pulmonary reasons being the major risk factors for mortality.

Major finding: Although standard mortality rates were similar between patients with PsA and the general population during the pre-pandemic period (0.95; 95% CI 0.61-1.49), the crude mortality rate, which was 5.07 before the pandemic, increased by 2.12-fold during the pandemic in the PsA population. Interestingly, deaths due to pulmonary reasons increased from 6% during the pre-pandemic era to 66% during the pandemic.

Study details: Findings are from an international multicenter registry study including 1216 patients with PsA who were followed up for 7500 patient-years.

Disclosures: This study did not report the source of funding. Some authors declared receiving honoraria or research grants from several sources.

Source: Erden A et al. Mortality in psoriatic arthritis patients, changes over time, and the impact of COVID-19: Results from a multicenter Psoriatic Arthritis Registry (PsART-ID). Clin Rheumatol. 2023;42(2):385-390(Jan 13). Doi: 10.1007/s10067-022-06492-6

Key clinical point: The crude mortality rate increased by two-fold in patients with psoriatic arthritis (PsA) during the COVID-19 pandemic compared with the pre-pandemic era, with pulmonary reasons being the major risk factors for mortality.

Major finding: Although standard mortality rates were similar between patients with PsA and the general population during the pre-pandemic period (0.95; 95% CI 0.61-1.49), the crude mortality rate, which was 5.07 before the pandemic, increased by 2.12-fold during the pandemic in the PsA population. Interestingly, deaths due to pulmonary reasons increased from 6% during the pre-pandemic era to 66% during the pandemic.

Study details: Findings are from an international multicenter registry study including 1216 patients with PsA who were followed up for 7500 patient-years.

Disclosures: This study did not report the source of funding. Some authors declared receiving honoraria or research grants from several sources.

Source: Erden A et al. Mortality in psoriatic arthritis patients, changes over time, and the impact of COVID-19: Results from a multicenter Psoriatic Arthritis Registry (PsART-ID). Clin Rheumatol. 2023;42(2):385-390(Jan 13). Doi: 10.1007/s10067-022-06492-6

Key clinical point: All multiple manifestations of psoriatic arthritis (PsA) negatively affect quality of life (QoL), with dactylitis, peripheral joint disease, and psoriasis impairing functional status, whereas joint, skin, and periarticular symptoms independently impair work productivity.

Major finding: Presence vs absence of enthesitis, dactylitis, inflammatory back pain, and peripheral joint involvement was associated with worse QoL and self-rated health (all P < .05), whereas increasing number of affected joints and greater body surface area involvement significantly correlated with poorer functional state and greater work productivity impairment (all P < .05).

Study details: Findings are from a cross-sectional observational study including 2222 patients with physician-confirmed diagnosis of PsA.

Disclosures: This study did not receive any specific funding. Some authors declared receiving grants from, serving as a consultant for, being an employee of, or owning shares in different sources.

Source: Walsh JA et al. Impact of key manifestations of psoriatic arthritis on patient quality of life, functional status, and work productivity: Findings from a real-world study in the United States and Europe. Joint Bone Spine. 2023;105534 (Jan 25). Doi: 10.1016/j.jbspin.2023.105534

Key clinical point: All multiple manifestations of psoriatic arthritis (PsA) negatively affect quality of life (QoL), with dactylitis, peripheral joint disease, and psoriasis impairing functional status, whereas joint, skin, and periarticular symptoms independently impair work productivity.

Major finding: Presence vs absence of enthesitis, dactylitis, inflammatory back pain, and peripheral joint involvement was associated with worse QoL and self-rated health (all P < .05), whereas increasing number of affected joints and greater body surface area involvement significantly correlated with poorer functional state and greater work productivity impairment (all P < .05).

Study details: Findings are from a cross-sectional observational study including 2222 patients with physician-confirmed diagnosis of PsA.

Disclosures: This study did not receive any specific funding. Some authors declared receiving grants from, serving as a consultant for, being an employee of, or owning shares in different sources.

Source: Walsh JA et al. Impact of key manifestations of psoriatic arthritis on patient quality of life, functional status, and work productivity: Findings from a real-world study in the United States and Europe. Joint Bone Spine. 2023;105534 (Jan 25). Doi: 10.1016/j.jbspin.2023.105534

Key clinical point: All multiple manifestations of psoriatic arthritis (PsA) negatively affect quality of life (QoL), with dactylitis, peripheral joint disease, and psoriasis impairing functional status, whereas joint, skin, and periarticular symptoms independently impair work productivity.

Major finding: Presence vs absence of enthesitis, dactylitis, inflammatory back pain, and peripheral joint involvement was associated with worse QoL and self-rated health (all P < .05), whereas increasing number of affected joints and greater body surface area involvement significantly correlated with poorer functional state and greater work productivity impairment (all P < .05).

Study details: Findings are from a cross-sectional observational study including 2222 patients with physician-confirmed diagnosis of PsA.

Disclosures: This study did not receive any specific funding. Some authors declared receiving grants from, serving as a consultant for, being an employee of, or owning shares in different sources.

Source: Walsh JA et al. Impact of key manifestations of psoriatic arthritis on patient quality of life, functional status, and work productivity: Findings from a real-world study in the United States and Europe. Joint Bone Spine. 2023;105534 (Jan 25). Doi: 10.1016/j.jbspin.2023.105534

Key clinical point:  Patients with psoriasis and concomitant psoriatic arthritis (PsA) had a greater comorbidity burden compared with those with psoriasis alone, which negatively impacted treatment persistence.

Major finding: Among patients receiving ustekinumab, those with concomitant PsA vs psoriasis alone had higher comorbidity burden, including diabetes (odds ratio [OR] 1.52; 95% CI 1.16-1.97), hypertension (OR 1.55; 95% CI 1.27-1.89), and obesity (OR 1.33; 95% CI 1.1-1.61), and a shorter time to ustekinumab discontinuation (hazard ratio 1.98; P < .0001).

Study details: This was a retrospective study including 9057 patients with plaque psoriasis alone or with concomitant PsA who received either ustekinumab or conventional systemic disease-modifying antirheumatic drugs.

Disclosures: This study was funded by Janssen-Cilag Ltd. W Tillett and A Ogdie declared receiving fees and grants or research support from various sources, including Janssen. A Passey and P Gorecki declared being employees of Janssen-Cilag Ltd.

Source: Tillett W et al. Impact of psoriatic arthritis and comorbidities on ustekinumab outcomes in psoriasis: A retrospective, observational BADBIR cohort study. RMD Open. 2023;9(1):e002533 (Jan 17). Doi: 10.1136/rmdopen-2022-002533

Key clinical point:  Patients with psoriasis and concomitant psoriatic arthritis (PsA) had a greater comorbidity burden compared with those with psoriasis alone, which negatively impacted treatment persistence.

Major finding: Among patients receiving ustekinumab, those with concomitant PsA vs psoriasis alone had higher comorbidity burden, including diabetes (odds ratio [OR] 1.52; 95% CI 1.16-1.97), hypertension (OR 1.55; 95% CI 1.27-1.89), and obesity (OR 1.33; 95% CI 1.1-1.61), and a shorter time to ustekinumab discontinuation (hazard ratio 1.98; P < .0001).

Study details: This was a retrospective study including 9057 patients with plaque psoriasis alone or with concomitant PsA who received either ustekinumab or conventional systemic disease-modifying antirheumatic drugs.

Disclosures: This study was funded by Janssen-Cilag Ltd. W Tillett and A Ogdie declared receiving fees and grants or research support from various sources, including Janssen. A Passey and P Gorecki declared being employees of Janssen-Cilag Ltd.

Source: Tillett W et al. Impact of psoriatic arthritis and comorbidities on ustekinumab outcomes in psoriasis: A retrospective, observational BADBIR cohort study. RMD Open. 2023;9(1):e002533 (Jan 17). Doi: 10.1136/rmdopen-2022-002533

Key clinical point:  Patients with psoriasis and concomitant psoriatic arthritis (PsA) had a greater comorbidity burden compared with those with psoriasis alone, which negatively impacted treatment persistence.

Major finding: Among patients receiving ustekinumab, those with concomitant PsA vs psoriasis alone had higher comorbidity burden, including diabetes (odds ratio [OR] 1.52; 95% CI 1.16-1.97), hypertension (OR 1.55; 95% CI 1.27-1.89), and obesity (OR 1.33; 95% CI 1.1-1.61), and a shorter time to ustekinumab discontinuation (hazard ratio 1.98; P < .0001).

Study details: This was a retrospective study including 9057 patients with plaque psoriasis alone or with concomitant PsA who received either ustekinumab or conventional systemic disease-modifying antirheumatic drugs.

Disclosures: This study was funded by Janssen-Cilag Ltd. W Tillett and A Ogdie declared receiving fees and grants or research support from various sources, including Janssen. A Passey and P Gorecki declared being employees of Janssen-Cilag Ltd.

Source: Tillett W et al. Impact of psoriatic arthritis and comorbidities on ustekinumab outcomes in psoriasis: A retrospective, observational BADBIR cohort study. RMD Open. 2023;9(1):e002533 (Jan 17). Doi: 10.1136/rmdopen-2022-002533

Key clinical point: Nailfold capillaroscopy (NC) outcomes could not conclusively differentiate psoriasis from psoriatic arthritis (PsA).

Major finding: In addition to altered morphology, the density of capillaries at the nailfold was significantly lower in patients with psoriasis (standardized group difference [SMD] −0.91; P  =  .0058; area under curve [AUC] 0.740) and PsA (SMD −1.22; P  =  .0432; AUC, 0.806) compared with control individuals; however, no NC outcomes conclusively differentiated between psoriasis and PsA.

Study details: Findings are from a systematic review and meta-analysis of 22 studies investigating NC as a diagnostic tool for psoriasis or  PsA.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Lazar LT et al. Nailfold capillaroscopy as diagnostic test in patients with psoriasis and psoriatic arthritis: A systematic review. Microvasc Res. 2023;147:104476 (Jan 16). Doi: 10.1016/j.mvr.2023.104476

Key clinical point: Nailfold capillaroscopy (NC) outcomes could not conclusively differentiate psoriasis from psoriatic arthritis (PsA).

Major finding: In addition to altered morphology, the density of capillaries at the nailfold was significantly lower in patients with psoriasis (standardized group difference [SMD] −0.91; P  =  .0058; area under curve [AUC] 0.740) and PsA (SMD −1.22; P  =  .0432; AUC, 0.806) compared with control individuals; however, no NC outcomes conclusively differentiated between psoriasis and PsA.

Study details: Findings are from a systematic review and meta-analysis of 22 studies investigating NC as a diagnostic tool for psoriasis or  PsA.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Lazar LT et al. Nailfold capillaroscopy as diagnostic test in patients with psoriasis and psoriatic arthritis: A systematic review. Microvasc Res. 2023;147:104476 (Jan 16). Doi: 10.1016/j.mvr.2023.104476

Key clinical point: Nailfold capillaroscopy (NC) outcomes could not conclusively differentiate psoriasis from psoriatic arthritis (PsA).

Major finding: In addition to altered morphology, the density of capillaries at the nailfold was significantly lower in patients with psoriasis (standardized group difference [SMD] −0.91; P  =  .0058; area under curve [AUC] 0.740) and PsA (SMD −1.22; P  =  .0432; AUC, 0.806) compared with control individuals; however, no NC outcomes conclusively differentiated between psoriasis and PsA.

Study details: Findings are from a systematic review and meta-analysis of 22 studies investigating NC as a diagnostic tool for psoriasis or  PsA.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Lazar LT et al. Nailfold capillaroscopy as diagnostic test in patients with psoriasis and psoriatic arthritis: A systematic review. Microvasc Res. 2023;147:104476 (Jan 16). Doi: 10.1016/j.mvr.2023.104476

Key clinical point: Regular assessment of bone mineral density and initiation of primary prevention should be considered in patients with psoriatic arthritis (PsA) as they are predisposed to falls and fractures because of reduced bone density, particularly those with late-onset psoriasis involving scalp.

Major finding: Patients with PsA were at a significantly higher risk for osteopenia or osteoporosis (odds ratio [OR] 21.9; CI 7.1-67.7) and prevalent fractures (OR 3.42; P  =  .002) compared with control individuals, with scalp involvement (P  =  .0049) and late onset of psoriasis (P  =  .029) being significantly associated with greater number of prevalent fractures.

Study details: Findings are from an observational cohort study including 61 patients with PsA and 69 age-matched control individuals.

Disclosures: This study did not report the source of funding. The authors reported no conflicts of interest.

Source: Halasi A et al. Psoriatic arthritis and its special features predispose not only for osteoporosis but also for fractures and falls. J Dermatol. 2023 (Jan 17). Doi: 10.1111/1346-8138.16710

Key clinical point: Regular assessment of bone mineral density and initiation of primary prevention should be considered in patients with psoriatic arthritis (PsA) as they are predisposed to falls and fractures because of reduced bone density, particularly those with late-onset psoriasis involving scalp.

Major finding: Patients with PsA were at a significantly higher risk for osteopenia or osteoporosis (odds ratio [OR] 21.9; CI 7.1-67.7) and prevalent fractures (OR 3.42; P  =  .002) compared with control individuals, with scalp involvement (P  =  .0049) and late onset of psoriasis (P  =  .029) being significantly associated with greater number of prevalent fractures.

Study details: Findings are from an observational cohort study including 61 patients with PsA and 69 age-matched control individuals.

Disclosures: This study did not report the source of funding. The authors reported no conflicts of interest.

Source: Halasi A et al. Psoriatic arthritis and its special features predispose not only for osteoporosis but also for fractures and falls. J Dermatol. 2023 (Jan 17). Doi: 10.1111/1346-8138.16710

Key clinical point: Regular assessment of bone mineral density and initiation of primary prevention should be considered in patients with psoriatic arthritis (PsA) as they are predisposed to falls and fractures because of reduced bone density, particularly those with late-onset psoriasis involving scalp.

Major finding: Patients with PsA were at a significantly higher risk for osteopenia or osteoporosis (odds ratio [OR] 21.9; CI 7.1-67.7) and prevalent fractures (OR 3.42; P  =  .002) compared with control individuals, with scalp involvement (P  =  .0049) and late onset of psoriasis (P  =  .029) being significantly associated with greater number of prevalent fractures.

Study details: Findings are from an observational cohort study including 61 patients with PsA and 69 age-matched control individuals.

Disclosures: This study did not report the source of funding. The authors reported no conflicts of interest.

Source: Halasi A et al. Psoriatic arthritis and its special features predispose not only for osteoporosis but also for fractures and falls. J Dermatol. 2023 (Jan 17). Doi: 10.1111/1346-8138.16710

I met Eleanor when I was writing a book on involuntary psychiatric treatment. She was very ill when she presented to an emergency department in Northern California. She was looking for help and would have signed herself in, but after waiting 8 hours with no food or medical attention, she walked out and went to another hospital.

At this point, she was agitated and distressed and began screaming uncontrollably. The physician in the second ED did not offer her the option of signing in, and she was placed on a 72-hour hold and subsequently held in the hospital for 3 weeks after a judge committed her.

Like so many issues, involuntary psychiatric care is highly polarized. Some groups favor legislation to make involuntary treatment easier, while patient advocacy and civil rights groups vehemently oppose such legislation.

We don’t hear from these combatants as much as we hear from those who trumpet their views on abortion or gun control, yet this battlefield exists. It is not surprising that when New York City Mayor Eric Adams announced a plan to hospitalize homeless people with mental illnesses – involuntarily if necessary, and at the discretion of the police – people were outraged.

New York City is not the only place using this strategy to address the problem of mental illness and homelessness; California has enacted similar legislation, and every major city has homeless citizens.

Eleanor was not homeless, and fortunately, she recovered and returned to her family. However, she remained distressed and traumatized by her hospitalization for years. “It sticks with you,” she told me. “I would rather die than go in again.”

I wish I could tell you that Eleanor is unique in saying that she would rather die than go to a hospital unit for treatment, but it is not an uncommon sentiment for patients. Some people who are charged with crimes and end up in the judicial system will opt to go to jail rather than to a psychiatric hospital. It is also not easy to access outpatient psychiatric treatment.
 

Barriers to care

Many psychiatrists don’t participate with insurance networks, and publicly funded clinics may have long waiting lists, so illnesses escalate until there is a crisis and hospitalization is necessary. For many, stigma and fear of potential professional repercussions are significant barriers to care.

What are the issues that legislation attempts to address? The first is the standard for hospitalizing individuals against their will. In some states, the patient must be dangerous, while in others there is a lower standard of “gravely disabled,” and finally there are those that promote a standard of a “need for treatment.”

The second is related to medicating people against their will, a process that can be rightly perceived as an assault if the patient refuses to take oral medications and must be held down for injections. Next, the use of outpatient civil commitment – legally requiring people to get treatment if they are not in the hospital – has been increasingly invoked as a way to prevent mass murders and random violence against strangers.

All but four states have some legislation for outpatient commitment, euphemistically called Assisted Outpatient Treatment (AOT), yet these laws are difficult to enforce and expensive to enact. They are also not fully effective.

In New York City, Kendra’s Law has not eliminated subway violence by people with psychiatric disturbances, and the shooter who killed 32 people and wounded 17 others at Virginia Tech in 2007 had previously been ordered by a judge to go to outpatient treatment, but he simply never showed up for his appointment.

Finally, the battle includes the right of patients to refuse to have their psychiatric information released to their caretakers under the Health Insurance Portability and Accountability Act of 1996 – a measure that many families believe would help them to get loved ones to take medications and go to appointments.

The concern about how to negotiate the needs of society and the civil rights of people with psychiatric disorders has been with us for centuries. There is a strong antipsychiatry movement that asserts that psychotropic medications are ineffective or harmful and refers to patients as “psychiatric survivors.” We value the right to medical autonomy, and when there is controversy over the validity of a treatment, there is even more controversy over forcing it upon people.

Psychiatric medications are very effective and benefit many people, but they don’t help everyone, and some people experience side effects. Also, we can’t deny that involuntary care can go wrong; the conservatorship of Britney Spears for 13 years is a very public example.
 

Multiple stakeholders

Many have a stake in how this plays out. There are the patients, who may be suffering and unable to recognize that they are ill, who may have valid reasons for not wanting the treatments, and who ideally should have the right to refuse care.

There are the families who watch their loved ones suffer, deteriorate, and miss the opportunities that life has to offer; who do not want their children to be homeless or incarcerated; and who may be at risk from violent behavior.

There are the mental health professionals who want to do what’s in the best interest of their patients while following legal and ethical mandates, who worry about being sued for tragic outcomes, and who can’t meet the current demand for services.

There is the taxpayer who foots the bill for disability payments, lost productivity, and institutionalization. There is our society that worries that people with psychiatric disorders will commit random acts of violence.

Finally, there are the insurers, who want to pay for as little care as possible and throw up constant hurdles in the treatment process. We must acknowledge that resources used for involuntary treatment are diverted away from those who want care.

Eleanor had many advantages that unhoused people don’t have: a supportive family, health insurance, and the financial means to pay a psychiatrist who respected her wishes to wean off her medications. She returned to a comfortable home and to personal and occupational success.

It is tragic that we have people living on the streets because of a psychiatric disorder, addiction, poverty, or some combination of these. No one should be unhoused. If the rationale of hospitalization is to decrease violence, I am not hopeful. The Epidemiologic Catchment Area study shows that people with psychiatric disorders are responsible for only 4% of all violence.

The logistics of determining which people living on the streets have psychiatric disorders, transporting them safely to medical facilities, and then finding the resources to provide for compassionate and thoughtful care in meaningful and sustained ways are very challenging.

If we don’t want people living on the streets, we need to create supports, including infrastructure to facilitate housing, access to mental health care, and addiction treatment before we resort to involuntary hospitalization.
 

Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

I met Eleanor when I was writing a book on involuntary psychiatric treatment. She was very ill when she presented to an emergency department in Northern California. She was looking for help and would have signed herself in, but after waiting 8 hours with no food or medical attention, she walked out and went to another hospital.

At this point, she was agitated and distressed and began screaming uncontrollably. The physician in the second ED did not offer her the option of signing in, and she was placed on a 72-hour hold and subsequently held in the hospital for 3 weeks after a judge committed her.

Like so many issues, involuntary psychiatric care is highly polarized. Some groups favor legislation to make involuntary treatment easier, while patient advocacy and civil rights groups vehemently oppose such legislation.

We don’t hear from these combatants as much as we hear from those who trumpet their views on abortion or gun control, yet this battlefield exists. It is not surprising that when New York City Mayor Eric Adams announced a plan to hospitalize homeless people with mental illnesses – involuntarily if necessary, and at the discretion of the police – people were outraged.

New York City is not the only place using this strategy to address the problem of mental illness and homelessness; California has enacted similar legislation, and every major city has homeless citizens.

Eleanor was not homeless, and fortunately, she recovered and returned to her family. However, she remained distressed and traumatized by her hospitalization for years. “It sticks with you,” she told me. “I would rather die than go in again.”

I wish I could tell you that Eleanor is unique in saying that she would rather die than go to a hospital unit for treatment, but it is not an uncommon sentiment for patients. Some people who are charged with crimes and end up in the judicial system will opt to go to jail rather than to a psychiatric hospital. It is also not easy to access outpatient psychiatric treatment.
 

Barriers to care

Many psychiatrists don’t participate with insurance networks, and publicly funded clinics may have long waiting lists, so illnesses escalate until there is a crisis and hospitalization is necessary. For many, stigma and fear of potential professional repercussions are significant barriers to care.

What are the issues that legislation attempts to address? The first is the standard for hospitalizing individuals against their will. In some states, the patient must be dangerous, while in others there is a lower standard of “gravely disabled,” and finally there are those that promote a standard of a “need for treatment.”

The second is related to medicating people against their will, a process that can be rightly perceived as an assault if the patient refuses to take oral medications and must be held down for injections. Next, the use of outpatient civil commitment – legally requiring people to get treatment if they are not in the hospital – has been increasingly invoked as a way to prevent mass murders and random violence against strangers.

All but four states have some legislation for outpatient commitment, euphemistically called Assisted Outpatient Treatment (AOT), yet these laws are difficult to enforce and expensive to enact. They are also not fully effective.

In New York City, Kendra’s Law has not eliminated subway violence by people with psychiatric disturbances, and the shooter who killed 32 people and wounded 17 others at Virginia Tech in 2007 had previously been ordered by a judge to go to outpatient treatment, but he simply never showed up for his appointment.

Finally, the battle includes the right of patients to refuse to have their psychiatric information released to their caretakers under the Health Insurance Portability and Accountability Act of 1996 – a measure that many families believe would help them to get loved ones to take medications and go to appointments.

The concern about how to negotiate the needs of society and the civil rights of people with psychiatric disorders has been with us for centuries. There is a strong antipsychiatry movement that asserts that psychotropic medications are ineffective or harmful and refers to patients as “psychiatric survivors.” We value the right to medical autonomy, and when there is controversy over the validity of a treatment, there is even more controversy over forcing it upon people.

Psychiatric medications are very effective and benefit many people, but they don’t help everyone, and some people experience side effects. Also, we can’t deny that involuntary care can go wrong; the conservatorship of Britney Spears for 13 years is a very public example.
 

Multiple stakeholders

Many have a stake in how this plays out. There are the patients, who may be suffering and unable to recognize that they are ill, who may have valid reasons for not wanting the treatments, and who ideally should have the right to refuse care.

There are the families who watch their loved ones suffer, deteriorate, and miss the opportunities that life has to offer; who do not want their children to be homeless or incarcerated; and who may be at risk from violent behavior.

There are the mental health professionals who want to do what’s in the best interest of their patients while following legal and ethical mandates, who worry about being sued for tragic outcomes, and who can’t meet the current demand for services.

There is the taxpayer who foots the bill for disability payments, lost productivity, and institutionalization. There is our society that worries that people with psychiatric disorders will commit random acts of violence.

Finally, there are the insurers, who want to pay for as little care as possible and throw up constant hurdles in the treatment process. We must acknowledge that resources used for involuntary treatment are diverted away from those who want care.

Eleanor had many advantages that unhoused people don’t have: a supportive family, health insurance, and the financial means to pay a psychiatrist who respected her wishes to wean off her medications. She returned to a comfortable home and to personal and occupational success.

It is tragic that we have people living on the streets because of a psychiatric disorder, addiction, poverty, or some combination of these. No one should be unhoused. If the rationale of hospitalization is to decrease violence, I am not hopeful. The Epidemiologic Catchment Area study shows that people with psychiatric disorders are responsible for only 4% of all violence.

The logistics of determining which people living on the streets have psychiatric disorders, transporting them safely to medical facilities, and then finding the resources to provide for compassionate and thoughtful care in meaningful and sustained ways are very challenging.

If we don’t want people living on the streets, we need to create supports, including infrastructure to facilitate housing, access to mental health care, and addiction treatment before we resort to involuntary hospitalization.
 

Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

I met Eleanor when I was writing a book on involuntary psychiatric treatment. She was very ill when she presented to an emergency department in Northern California. She was looking for help and would have signed herself in, but after waiting 8 hours with no food or medical attention, she walked out and went to another hospital.

At this point, she was agitated and distressed and began screaming uncontrollably. The physician in the second ED did not offer her the option of signing in, and she was placed on a 72-hour hold and subsequently held in the hospital for 3 weeks after a judge committed her.

Like so many issues, involuntary psychiatric care is highly polarized. Some groups favor legislation to make involuntary treatment easier, while patient advocacy and civil rights groups vehemently oppose such legislation.

We don’t hear from these combatants as much as we hear from those who trumpet their views on abortion or gun control, yet this battlefield exists. It is not surprising that when New York City Mayor Eric Adams announced a plan to hospitalize homeless people with mental illnesses – involuntarily if necessary, and at the discretion of the police – people were outraged.

New York City is not the only place using this strategy to address the problem of mental illness and homelessness; California has enacted similar legislation, and every major city has homeless citizens.

Eleanor was not homeless, and fortunately, she recovered and returned to her family. However, she remained distressed and traumatized by her hospitalization for years. “It sticks with you,” she told me. “I would rather die than go in again.”

I wish I could tell you that Eleanor is unique in saying that she would rather die than go to a hospital unit for treatment, but it is not an uncommon sentiment for patients. Some people who are charged with crimes and end up in the judicial system will opt to go to jail rather than to a psychiatric hospital. It is also not easy to access outpatient psychiatric treatment.
 

Barriers to care

Many psychiatrists don’t participate with insurance networks, and publicly funded clinics may have long waiting lists, so illnesses escalate until there is a crisis and hospitalization is necessary. For many, stigma and fear of potential professional repercussions are significant barriers to care.

What are the issues that legislation attempts to address? The first is the standard for hospitalizing individuals against their will. In some states, the patient must be dangerous, while in others there is a lower standard of “gravely disabled,” and finally there are those that promote a standard of a “need for treatment.”

The second is related to medicating people against their will, a process that can be rightly perceived as an assault if the patient refuses to take oral medications and must be held down for injections. Next, the use of outpatient civil commitment – legally requiring people to get treatment if they are not in the hospital – has been increasingly invoked as a way to prevent mass murders and random violence against strangers.

All but four states have some legislation for outpatient commitment, euphemistically called Assisted Outpatient Treatment (AOT), yet these laws are difficult to enforce and expensive to enact. They are also not fully effective.

In New York City, Kendra’s Law has not eliminated subway violence by people with psychiatric disturbances, and the shooter who killed 32 people and wounded 17 others at Virginia Tech in 2007 had previously been ordered by a judge to go to outpatient treatment, but he simply never showed up for his appointment.

Finally, the battle includes the right of patients to refuse to have their psychiatric information released to their caretakers under the Health Insurance Portability and Accountability Act of 1996 – a measure that many families believe would help them to get loved ones to take medications and go to appointments.

The concern about how to negotiate the needs of society and the civil rights of people with psychiatric disorders has been with us for centuries. There is a strong antipsychiatry movement that asserts that psychotropic medications are ineffective or harmful and refers to patients as “psychiatric survivors.” We value the right to medical autonomy, and when there is controversy over the validity of a treatment, there is even more controversy over forcing it upon people.

Psychiatric medications are very effective and benefit many people, but they don’t help everyone, and some people experience side effects. Also, we can’t deny that involuntary care can go wrong; the conservatorship of Britney Spears for 13 years is a very public example.
 

Multiple stakeholders

Many have a stake in how this plays out. There are the patients, who may be suffering and unable to recognize that they are ill, who may have valid reasons for not wanting the treatments, and who ideally should have the right to refuse care.

There are the families who watch their loved ones suffer, deteriorate, and miss the opportunities that life has to offer; who do not want their children to be homeless or incarcerated; and who may be at risk from violent behavior.

There are the mental health professionals who want to do what’s in the best interest of their patients while following legal and ethical mandates, who worry about being sued for tragic outcomes, and who can’t meet the current demand for services.

There is the taxpayer who foots the bill for disability payments, lost productivity, and institutionalization. There is our society that worries that people with psychiatric disorders will commit random acts of violence.

Finally, there are the insurers, who want to pay for as little care as possible and throw up constant hurdles in the treatment process. We must acknowledge that resources used for involuntary treatment are diverted away from those who want care.

Eleanor had many advantages that unhoused people don’t have: a supportive family, health insurance, and the financial means to pay a psychiatrist who respected her wishes to wean off her medications. She returned to a comfortable home and to personal and occupational success.

It is tragic that we have people living on the streets because of a psychiatric disorder, addiction, poverty, or some combination of these. No one should be unhoused. If the rationale of hospitalization is to decrease violence, I am not hopeful. The Epidemiologic Catchment Area study shows that people with psychiatric disorders are responsible for only 4% of all violence.

The logistics of determining which people living on the streets have psychiatric disorders, transporting them safely to medical facilities, and then finding the resources to provide for compassionate and thoughtful care in meaningful and sustained ways are very challenging.

If we don’t want people living on the streets, we need to create supports, including infrastructure to facilitate housing, access to mental health care, and addiction treatment before we resort to involuntary hospitalization.
 

Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

Key clinical point: A dose of 100 mg guselkumab every 4 or 8 weeks (Q4W/Q8W) demonstrated a favorable and consistent safety profile for up to 2 years in both tumor necrosis factor-α inhibitor (TNFi)-naive and TNFi-experienced patients with active psoriatic arthritis (PsA).

Major finding: In TNFi-naive vs TNFi-experienced patients receiving guselkumab, adverse events rates were consistent through 24 weeks (220.8/100 person-years [PY] vs 251.6/100 PY) and remained low through 2 years (139.69/100 PY vs 174.0/100 PY).

Study details: This pooled safety analysis of four phase 2/3 trials included 1554 TNFi-naive and TNFi-experienced patients with active PsA who were randomly assigned to receive 100 mg guselkumab Q4W or Q8W for ≤2 years or placebo with a crossover at week 24 to guselkumab Q4W or Q8W.

Disclosures: The four trials were funded by Janssen Research & Development, LLC. Seven authors declared being current or former employees of Janssen or owning stock or stock options in Johnson & Johnson. Several authors reported ties with Janssen and other sources.

Source: Rahman P et al. Safety of guselkumab with and without prior TNF-α inhibitor treatment: Pooled results across four studies in patients with psoriatic arthritis. J Rheumatol. 2023 (Jan 15). Doi: 10.3899/jrheum.220928

Key clinical point: A dose of 100 mg guselkumab every 4 or 8 weeks (Q4W/Q8W) demonstrated a favorable and consistent safety profile for up to 2 years in both tumor necrosis factor-α inhibitor (TNFi)-naive and TNFi-experienced patients with active psoriatic arthritis (PsA).

Major finding: In TNFi-naive vs TNFi-experienced patients receiving guselkumab, adverse events rates were consistent through 24 weeks (220.8/100 person-years [PY] vs 251.6/100 PY) and remained low through 2 years (139.69/100 PY vs 174.0/100 PY).

Study details: This pooled safety analysis of four phase 2/3 trials included 1554 TNFi-naive and TNFi-experienced patients with active PsA who were randomly assigned to receive 100 mg guselkumab Q4W or Q8W for ≤2 years or placebo with a crossover at week 24 to guselkumab Q4W or Q8W.

Disclosures: The four trials were funded by Janssen Research & Development, LLC. Seven authors declared being current or former employees of Janssen or owning stock or stock options in Johnson & Johnson. Several authors reported ties with Janssen and other sources.

Source: Rahman P et al. Safety of guselkumab with and without prior TNF-α inhibitor treatment: Pooled results across four studies in patients with psoriatic arthritis. J Rheumatol. 2023 (Jan 15). Doi: 10.3899/jrheum.220928

Key clinical point: A dose of 100 mg guselkumab every 4 or 8 weeks (Q4W/Q8W) demonstrated a favorable and consistent safety profile for up to 2 years in both tumor necrosis factor-α inhibitor (TNFi)-naive and TNFi-experienced patients with active psoriatic arthritis (PsA).

Major finding: In TNFi-naive vs TNFi-experienced patients receiving guselkumab, adverse events rates were consistent through 24 weeks (220.8/100 person-years [PY] vs 251.6/100 PY) and remained low through 2 years (139.69/100 PY vs 174.0/100 PY).

Study details: This pooled safety analysis of four phase 2/3 trials included 1554 TNFi-naive and TNFi-experienced patients with active PsA who were randomly assigned to receive 100 mg guselkumab Q4W or Q8W for ≤2 years or placebo with a crossover at week 24 to guselkumab Q4W or Q8W.

Disclosures: The four trials were funded by Janssen Research & Development, LLC. Seven authors declared being current or former employees of Janssen or owning stock or stock options in Johnson & Johnson. Several authors reported ties with Janssen and other sources.

Source: Rahman P et al. Safety of guselkumab with and without prior TNF-α inhibitor treatment: Pooled results across four studies in patients with psoriatic arthritis. J Rheumatol. 2023 (Jan 15). Doi: 10.3899/jrheum.220928

When administered subcutaneously every 2 weeks, secukinumab was effective at improving signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adults up to 52 weeks, results from two pivotal phase 3 clinical trials showed.

The findings build on week 16 data from two trials – SUNSHINE and SUNRISE – that investigated the efficacy, safety, and tolerability of the interleukin-17A inhibitor secukinumab (Cosentyx) versus placebo in the treatment of moderate to severe HS, and were presented at the 2022 annual congress of the European Academy of Dermatology and Venereology. In those studies, at 16 weeks, 42%-46% of patients achieved an HS Clinical Response (HiSCR) – the primary outcome measure in both trials. For the most recent analysis, which was published in The Lancet, investigators found that, at 52 weeks, 56.4% of patients in SUNSHINE and 65% of patients in SUNRISE who received secukinumab 300 mg every 2 weeks achieved a HiSCR, compared with 56.3% of patients in SUNSHINE and 62.2% of patients in SUNRISE who received secukinumab 300 mg every 4 weeks.

“This is great news for people with HS: it improves our knowledge about how to best treat patients today and leads us to new areas that will help us treat them even better in the future,” Alexa B. Kimball, MD, MPH, the lead investigator for both trials, said in an interview. “Dermatologists have been using biologics for decades. This data provides clinicians with information they can use to easily expand their HS management repertoire to include secukinumab.”

To date, the tumor necrosis factor inhibitor adalimumab is the only approved biologic therapy approved for the treatment of moderate-to-severe HS, in people aged 12 years and older.

The two trials were conducted in 40 countries, with SUNSHINE enrolling 541 patients, and SUNRISE enrolling 543. Patients in each study were randomized to one of three experimental arms: secukinumab 300 mg every 2 weeks after five weekly loading doses; secukinumab 300 mg every 4 weeks after five weekly loading doses; placebo dose every 2 weeks after five weekly placebo doses. The mean age was 37 years, about 55% were female, and about 76% were White (about 9% were Black and about 10% were Asian). Dr. Kimball, investigator at Beth Israel Deaconess Medical Center and professor of dermatology at Harvard Medical School, Boston, and coauthors observed that the group that received secukinumab every 4 weeks did not meet the primary endpoint in the SUNSHINE trial, but it was met in the SUNRISE trial. “Research and subgroup analyses are required and might improve our understanding of the effect of patient characteristics on treatment response and further refine the dosing recommendations for different populations,” they wrote.

In a pooled analysis, 55.2% of patients from SUNSHINE and SUNRISE who received secukinumab 300 mg every 2 weeks had a reduction in pain as measured by the Patient’s Global Assessment of Skin Pain Numeric Rating Scale, compared with 53% of patients from SUNSHINE and SUNRISE who received secukinumab 300 mg every 4 weeks. The most common adverse events up to week 16 in both trials were headache, nasopharyngitis, and hidradenitis; no deaths occurred.

“One limitation of most studies in HS is that the placebo-controlled period is short, so the data obtained after that time is harder to interpret,” Dr. Kimball said in an interview. “In my experience, optimizing treatment can take almost a year and I hope we will see longer controlled periods in future studies.” Another limitation of the studies she acknowledged was a modest imbalance with respect to disease severity between the treatment groups at baseline. “It was a little surprising that some imbalances in the characteristics of randomized subjects in different arms of the study impacted efficacy levels,” she said. “We’ll need to continue to identify how to match patients and dosing regimens to get the best results.”

According to a press release from Novartis, trial results have been submitted to regulatory authorities in Europe and the United States, and decisions are expected in 2023. If approved, secukinumab will be the first and only IL-17 inhibitor for the treatment of moderate to severe HS.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, described HS as “an extraordinarily disabling, painful, deforming condition for which we only have one [Food and Drug Administration]–approved systemic therapy, requiring us to wear our ‘off-label bandit’ name tags proudly to tackle therapeutic challenges.

“Anecdotally,” he said, “we dabble with off-label biologics indicated for psoriasis in this setting, though limitations exist ranging from lack of large-scale clinical data to the recurring theme that psoriasis dosing typically doesn’t cut it, making access to said medications even more difficult. Investigators in this study addresses both gaps very effectively, and I for one welcome the implications and hopeful regulatory impact with open arms.”

The study was funded by Novartis. Dr. Kimball disclosed numerous conflicts of interest from various pharmaceutical companies. Dr. Friedman reported financial relationships with Sanova, Pfizer, Novartis, and other companies.

When administered subcutaneously every 2 weeks, secukinumab was effective at improving signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adults up to 52 weeks, results from two pivotal phase 3 clinical trials showed.

The findings build on week 16 data from two trials – SUNSHINE and SUNRISE – that investigated the efficacy, safety, and tolerability of the interleukin-17A inhibitor secukinumab (Cosentyx) versus placebo in the treatment of moderate to severe HS, and were presented at the 2022 annual congress of the European Academy of Dermatology and Venereology. In those studies, at 16 weeks, 42%-46% of patients achieved an HS Clinical Response (HiSCR) – the primary outcome measure in both trials. For the most recent analysis, which was published in The Lancet, investigators found that, at 52 weeks, 56.4% of patients in SUNSHINE and 65% of patients in SUNRISE who received secukinumab 300 mg every 2 weeks achieved a HiSCR, compared with 56.3% of patients in SUNSHINE and 62.2% of patients in SUNRISE who received secukinumab 300 mg every 4 weeks.

“This is great news for people with HS: it improves our knowledge about how to best treat patients today and leads us to new areas that will help us treat them even better in the future,” Alexa B. Kimball, MD, MPH, the lead investigator for both trials, said in an interview. “Dermatologists have been using biologics for decades. This data provides clinicians with information they can use to easily expand their HS management repertoire to include secukinumab.”

To date, the tumor necrosis factor inhibitor adalimumab is the only approved biologic therapy approved for the treatment of moderate-to-severe HS, in people aged 12 years and older.

The two trials were conducted in 40 countries, with SUNSHINE enrolling 541 patients, and SUNRISE enrolling 543. Patients in each study were randomized to one of three experimental arms: secukinumab 300 mg every 2 weeks after five weekly loading doses; secukinumab 300 mg every 4 weeks after five weekly loading doses; placebo dose every 2 weeks after five weekly placebo doses. The mean age was 37 years, about 55% were female, and about 76% were White (about 9% were Black and about 10% were Asian). Dr. Kimball, investigator at Beth Israel Deaconess Medical Center and professor of dermatology at Harvard Medical School, Boston, and coauthors observed that the group that received secukinumab every 4 weeks did not meet the primary endpoint in the SUNSHINE trial, but it was met in the SUNRISE trial. “Research and subgroup analyses are required and might improve our understanding of the effect of patient characteristics on treatment response and further refine the dosing recommendations for different populations,” they wrote.

In a pooled analysis, 55.2% of patients from SUNSHINE and SUNRISE who received secukinumab 300 mg every 2 weeks had a reduction in pain as measured by the Patient’s Global Assessment of Skin Pain Numeric Rating Scale, compared with 53% of patients from SUNSHINE and SUNRISE who received secukinumab 300 mg every 4 weeks. The most common adverse events up to week 16 in both trials were headache, nasopharyngitis, and hidradenitis; no deaths occurred.

“One limitation of most studies in HS is that the placebo-controlled period is short, so the data obtained after that time is harder to interpret,” Dr. Kimball said in an interview. “In my experience, optimizing treatment can take almost a year and I hope we will see longer controlled periods in future studies.” Another limitation of the studies she acknowledged was a modest imbalance with respect to disease severity between the treatment groups at baseline. “It was a little surprising that some imbalances in the characteristics of randomized subjects in different arms of the study impacted efficacy levels,” she said. “We’ll need to continue to identify how to match patients and dosing regimens to get the best results.”

According to a press release from Novartis, trial results have been submitted to regulatory authorities in Europe and the United States, and decisions are expected in 2023. If approved, secukinumab will be the first and only IL-17 inhibitor for the treatment of moderate to severe HS.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, described HS as “an extraordinarily disabling, painful, deforming condition for which we only have one [Food and Drug Administration]–approved systemic therapy, requiring us to wear our ‘off-label bandit’ name tags proudly to tackle therapeutic challenges.

“Anecdotally,” he said, “we dabble with off-label biologics indicated for psoriasis in this setting, though limitations exist ranging from lack of large-scale clinical data to the recurring theme that psoriasis dosing typically doesn’t cut it, making access to said medications even more difficult. Investigators in this study addresses both gaps very effectively, and I for one welcome the implications and hopeful regulatory impact with open arms.”

The study was funded by Novartis. Dr. Kimball disclosed numerous conflicts of interest from various pharmaceutical companies. Dr. Friedman reported financial relationships with Sanova, Pfizer, Novartis, and other companies.

When administered subcutaneously every 2 weeks, secukinumab was effective at improving signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adults up to 52 weeks, results from two pivotal phase 3 clinical trials showed.

The findings build on week 16 data from two trials – SUNSHINE and SUNRISE – that investigated the efficacy, safety, and tolerability of the interleukin-17A inhibitor secukinumab (Cosentyx) versus placebo in the treatment of moderate to severe HS, and were presented at the 2022 annual congress of the European Academy of Dermatology and Venereology. In those studies, at 16 weeks, 42%-46% of patients achieved an HS Clinical Response (HiSCR) – the primary outcome measure in both trials. For the most recent analysis, which was published in The Lancet, investigators found that, at 52 weeks, 56.4% of patients in SUNSHINE and 65% of patients in SUNRISE who received secukinumab 300 mg every 2 weeks achieved a HiSCR, compared with 56.3% of patients in SUNSHINE and 62.2% of patients in SUNRISE who received secukinumab 300 mg every 4 weeks.

“This is great news for people with HS: it improves our knowledge about how to best treat patients today and leads us to new areas that will help us treat them even better in the future,” Alexa B. Kimball, MD, MPH, the lead investigator for both trials, said in an interview. “Dermatologists have been using biologics for decades. This data provides clinicians with information they can use to easily expand their HS management repertoire to include secukinumab.”

To date, the tumor necrosis factor inhibitor adalimumab is the only approved biologic therapy approved for the treatment of moderate-to-severe HS, in people aged 12 years and older.

The two trials were conducted in 40 countries, with SUNSHINE enrolling 541 patients, and SUNRISE enrolling 543. Patients in each study were randomized to one of three experimental arms: secukinumab 300 mg every 2 weeks after five weekly loading doses; secukinumab 300 mg every 4 weeks after five weekly loading doses; placebo dose every 2 weeks after five weekly placebo doses. The mean age was 37 years, about 55% were female, and about 76% were White (about 9% were Black and about 10% were Asian). Dr. Kimball, investigator at Beth Israel Deaconess Medical Center and professor of dermatology at Harvard Medical School, Boston, and coauthors observed that the group that received secukinumab every 4 weeks did not meet the primary endpoint in the SUNSHINE trial, but it was met in the SUNRISE trial. “Research and subgroup analyses are required and might improve our understanding of the effect of patient characteristics on treatment response and further refine the dosing recommendations for different populations,” they wrote.

In a pooled analysis, 55.2% of patients from SUNSHINE and SUNRISE who received secukinumab 300 mg every 2 weeks had a reduction in pain as measured by the Patient’s Global Assessment of Skin Pain Numeric Rating Scale, compared with 53% of patients from SUNSHINE and SUNRISE who received secukinumab 300 mg every 4 weeks. The most common adverse events up to week 16 in both trials were headache, nasopharyngitis, and hidradenitis; no deaths occurred.

“One limitation of most studies in HS is that the placebo-controlled period is short, so the data obtained after that time is harder to interpret,” Dr. Kimball said in an interview. “In my experience, optimizing treatment can take almost a year and I hope we will see longer controlled periods in future studies.” Another limitation of the studies she acknowledged was a modest imbalance with respect to disease severity between the treatment groups at baseline. “It was a little surprising that some imbalances in the characteristics of randomized subjects in different arms of the study impacted efficacy levels,” she said. “We’ll need to continue to identify how to match patients and dosing regimens to get the best results.”

According to a press release from Novartis, trial results have been submitted to regulatory authorities in Europe and the United States, and decisions are expected in 2023. If approved, secukinumab will be the first and only IL-17 inhibitor for the treatment of moderate to severe HS.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, described HS as “an extraordinarily disabling, painful, deforming condition for which we only have one [Food and Drug Administration]–approved systemic therapy, requiring us to wear our ‘off-label bandit’ name tags proudly to tackle therapeutic challenges.

“Anecdotally,” he said, “we dabble with off-label biologics indicated for psoriasis in this setting, though limitations exist ranging from lack of large-scale clinical data to the recurring theme that psoriasis dosing typically doesn’t cut it, making access to said medications even more difficult. Investigators in this study addresses both gaps very effectively, and I for one welcome the implications and hopeful regulatory impact with open arms.”

The study was funded by Novartis. Dr. Kimball disclosed numerous conflicts of interest from various pharmaceutical companies. Dr. Friedman reported financial relationships with Sanova, Pfizer, Novartis, and other companies.