Psoriatic Arthritis

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

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

Real-world, population-based data suggest that the discontinuation rates for biosimilars prescribed to treat inflammatory rheumatic diseases are similar to those for their corresponding originator biologics, according to a study of patients in British Columbia who were required to switch to biosimilars.

“The decision to mandate use of biosimilars provided an ideal context for a natural experiment,” Diane Lacaille, MD, chair in arthritis research at the University of British Columbia, Vancouver, explained in her presentation of the study at the annual meeting of the Canadian Rheumatology Association.

On the basis of the real-world data, which was collected before and after a province-wide requirement to use biosimilars in place of originator biologics, there was no major difference in discontinuation rates, an outcome that Dr. Lacaille characterized as “a surrogate for both efficacy and safety.”

In the 2019 rheumatoid arthritis treatment guidelines from the European Alliance of Associations for Rheumatology, biosimilars are advocated for addressing the high cost of biologics based on evidence of efficacy and safety comparable with originator biologics. According to one of the coauthors of those guidelines, Tom W. J. Huizinga, MD, PhD, head of rheumatology at Leiden (Netherlands) University Medical Center, there is reasonable confidence in biosimilars as an adequate substitute for originator drugs, but real-world data are welcome.

“Real-world data provide different information than controlled trials and long-term data as well, so these [Canadian findings] are useful to support the data from [randomized controlled trials],” Dr. Huizinga said in an interview. He was not involved in the Canadian study.
 

Survivorship evaluated after switch to biosimilars

In British Columbia, biosimilars were mandated province-wide for new prescriptions of infliximab and etanercept in June 2017. In 2019, the mandate was extended to patients already taking originator infliximab (Remicade) and originator etanercept (Enbrel). Since that time, the mandate for biosimilars has also been applied to adalimumab (Humira). For the comparison of infliximab and etanercept originators with their biosimilars, Dr. Lacaille and associates compared survivorship for the 3 years after the policy change, when patients were on biosimilars, with the 3 years prior to the change, when patients were on the originators. They compared survivorship with originator adalimumab with its biosimilars for prior to and after the switch.

”People were followed from anti-TNF [tumor necrosis factor] initiation until discontinuation for any reason,” reported Dr. Lacaille, who said data were censored for death and moving out of the province. In British Columbia, where there is universal health care, all dispensed medications can be tracked. The definition of anti-TNF discontinuation in this study was no prescription renewal for at least 6 months.

The follow-up was censored at March 2, 2020, to avoid the potential impact of COVID-19 on antirheumatic drug use. Discontinuation was standardized for the comparison of originator with biosimilar drugs as rates per 100 person-years. Statistical adjustments were made for potential confounders.

The researchers compared 1,312 patients on etanercept and 827 on a biosimilar of it, 230 patients on infliximab and 271 on a biosimilar of it, and 1,773 on adalimumab and 2,213 on a biosimilar of it. The indication was RA in approximately 60% of those on etanercept or a biosimilar and 50% of those on infliximab or adalimumab and their biosimilars. More than half of the remaining patients had indications for psoriatic arthritis, and the rest had ankylosing spondylitis.
 

No differences reach statistical significance

On the basis of discontinuation rates per 100 person-years, etanercept and its biosimilars performed almost identically (37.10 vs. 37.02, respectively). Although the discontinuation rate per 100 person-years was lower on infliximab than a biosimilar of it (29.97 vs. 37.96), the difference was not statistically significant (P = .076).

For adalimumab, the discontinuation rate was also lower on the originator drug than a biosimilar of it (32.92 vs. 36.36), but, again, this difference was also insignificant (P = .56).

When the discontinuation data were evaluated on the basis of a Cox model involving a propensity weight overlap, the univariate and the multivariable analyses found that the biosimilars had similar risks for discontinuation. Univariate analysis revealed hazard ratios for discontinuation of the biosimilar relative to the originator were 0.98 (P = .783) for etanercept, 1.17 (P = .242) for infliximab, and 1.08 (P = .09) for adalimumab. In the multivariable model, adjusted HRs for discontinuation were about the same for each of the biosimilars relative to the originator: 0.98 (P = .807) for etanercept, 1.19 (P = .183) for infliximab, and 1.08 (P = .089) for adalimumab.

Relative to previously published direct comparisons, this real-world analysis and its duration of follow-up address the limitations of formal trials. In a 2020 BMJ meta-analysis of published data from 45 trials comparing biosimilar with originator drugs in patients with RA who had failed methotrexate, the authors found only “minor differences in harms and benefits,” but they cautioned that the analysis was “hampered by a lack of long-term direct comparisons.”

In an interview, Dr. Huizinga noted that a systematic review of adalimumab biosimilars that he led 2 years ago showed that they perform comparably with the originator biologics. This and other published studies have consistently shown “that there is no difference between biologics and originators.”

Dr. Lacaille disclosed financial relationships with Fresenius Kabi, Janssen, Organon, Pfizer, and Viatris. Dr. Huizinga disclosed financial relationships with Abbott, Ablynx, Biotest, Bioscience, Boehringer Ingelheim, Bristol-Myers Squibb, Crescendo Bioscience, Eli Lilly, Galapagos, Janssen, Merck, Novartis, MycoMed, Roche, Sanofi-Aventis, Takeda, and Zydus.

Real-world, population-based data suggest that the discontinuation rates for biosimilars prescribed to treat inflammatory rheumatic diseases are similar to those for their corresponding originator biologics, according to a study of patients in British Columbia who were required to switch to biosimilars.

“The decision to mandate use of biosimilars provided an ideal context for a natural experiment,” Diane Lacaille, MD, chair in arthritis research at the University of British Columbia, Vancouver, explained in her presentation of the study at the annual meeting of the Canadian Rheumatology Association.

On the basis of the real-world data, which was collected before and after a province-wide requirement to use biosimilars in place of originator biologics, there was no major difference in discontinuation rates, an outcome that Dr. Lacaille characterized as “a surrogate for both efficacy and safety.”

In the 2019 rheumatoid arthritis treatment guidelines from the European Alliance of Associations for Rheumatology, biosimilars are advocated for addressing the high cost of biologics based on evidence of efficacy and safety comparable with originator biologics. According to one of the coauthors of those guidelines, Tom W. J. Huizinga, MD, PhD, head of rheumatology at Leiden (Netherlands) University Medical Center, there is reasonable confidence in biosimilars as an adequate substitute for originator drugs, but real-world data are welcome.

“Real-world data provide different information than controlled trials and long-term data as well, so these [Canadian findings] are useful to support the data from [randomized controlled trials],” Dr. Huizinga said in an interview. He was not involved in the Canadian study.
 

Survivorship evaluated after switch to biosimilars

In British Columbia, biosimilars were mandated province-wide for new prescriptions of infliximab and etanercept in June 2017. In 2019, the mandate was extended to patients already taking originator infliximab (Remicade) and originator etanercept (Enbrel). Since that time, the mandate for biosimilars has also been applied to adalimumab (Humira). For the comparison of infliximab and etanercept originators with their biosimilars, Dr. Lacaille and associates compared survivorship for the 3 years after the policy change, when patients were on biosimilars, with the 3 years prior to the change, when patients were on the originators. They compared survivorship with originator adalimumab with its biosimilars for prior to and after the switch.

”People were followed from anti-TNF [tumor necrosis factor] initiation until discontinuation for any reason,” reported Dr. Lacaille, who said data were censored for death and moving out of the province. In British Columbia, where there is universal health care, all dispensed medications can be tracked. The definition of anti-TNF discontinuation in this study was no prescription renewal for at least 6 months.

The follow-up was censored at March 2, 2020, to avoid the potential impact of COVID-19 on antirheumatic drug use. Discontinuation was standardized for the comparison of originator with biosimilar drugs as rates per 100 person-years. Statistical adjustments were made for potential confounders.

The researchers compared 1,312 patients on etanercept and 827 on a biosimilar of it, 230 patients on infliximab and 271 on a biosimilar of it, and 1,773 on adalimumab and 2,213 on a biosimilar of it. The indication was RA in approximately 60% of those on etanercept or a biosimilar and 50% of those on infliximab or adalimumab and their biosimilars. More than half of the remaining patients had indications for psoriatic arthritis, and the rest had ankylosing spondylitis.
 

No differences reach statistical significance

On the basis of discontinuation rates per 100 person-years, etanercept and its biosimilars performed almost identically (37.10 vs. 37.02, respectively). Although the discontinuation rate per 100 person-years was lower on infliximab than a biosimilar of it (29.97 vs. 37.96), the difference was not statistically significant (P = .076).

For adalimumab, the discontinuation rate was also lower on the originator drug than a biosimilar of it (32.92 vs. 36.36), but, again, this difference was also insignificant (P = .56).

When the discontinuation data were evaluated on the basis of a Cox model involving a propensity weight overlap, the univariate and the multivariable analyses found that the biosimilars had similar risks for discontinuation. Univariate analysis revealed hazard ratios for discontinuation of the biosimilar relative to the originator were 0.98 (P = .783) for etanercept, 1.17 (P = .242) for infliximab, and 1.08 (P = .09) for adalimumab. In the multivariable model, adjusted HRs for discontinuation were about the same for each of the biosimilars relative to the originator: 0.98 (P = .807) for etanercept, 1.19 (P = .183) for infliximab, and 1.08 (P = .089) for adalimumab.

Relative to previously published direct comparisons, this real-world analysis and its duration of follow-up address the limitations of formal trials. In a 2020 BMJ meta-analysis of published data from 45 trials comparing biosimilar with originator drugs in patients with RA who had failed methotrexate, the authors found only “minor differences in harms and benefits,” but they cautioned that the analysis was “hampered by a lack of long-term direct comparisons.”

In an interview, Dr. Huizinga noted that a systematic review of adalimumab biosimilars that he led 2 years ago showed that they perform comparably with the originator biologics. This and other published studies have consistently shown “that there is no difference between biologics and originators.”

Dr. Lacaille disclosed financial relationships with Fresenius Kabi, Janssen, Organon, Pfizer, and Viatris. Dr. Huizinga disclosed financial relationships with Abbott, Ablynx, Biotest, Bioscience, Boehringer Ingelheim, Bristol-Myers Squibb, Crescendo Bioscience, Eli Lilly, Galapagos, Janssen, Merck, Novartis, MycoMed, Roche, Sanofi-Aventis, Takeda, and Zydus.

Real-world, population-based data suggest that the discontinuation rates for biosimilars prescribed to treat inflammatory rheumatic diseases are similar to those for their corresponding originator biologics, according to a study of patients in British Columbia who were required to switch to biosimilars.

“The decision to mandate use of biosimilars provided an ideal context for a natural experiment,” Diane Lacaille, MD, chair in arthritis research at the University of British Columbia, Vancouver, explained in her presentation of the study at the annual meeting of the Canadian Rheumatology Association.

On the basis of the real-world data, which was collected before and after a province-wide requirement to use biosimilars in place of originator biologics, there was no major difference in discontinuation rates, an outcome that Dr. Lacaille characterized as “a surrogate for both efficacy and safety.”

In the 2019 rheumatoid arthritis treatment guidelines from the European Alliance of Associations for Rheumatology, biosimilars are advocated for addressing the high cost of biologics based on evidence of efficacy and safety comparable with originator biologics. According to one of the coauthors of those guidelines, Tom W. J. Huizinga, MD, PhD, head of rheumatology at Leiden (Netherlands) University Medical Center, there is reasonable confidence in biosimilars as an adequate substitute for originator drugs, but real-world data are welcome.

“Real-world data provide different information than controlled trials and long-term data as well, so these [Canadian findings] are useful to support the data from [randomized controlled trials],” Dr. Huizinga said in an interview. He was not involved in the Canadian study.
 

Survivorship evaluated after switch to biosimilars

In British Columbia, biosimilars were mandated province-wide for new prescriptions of infliximab and etanercept in June 2017. In 2019, the mandate was extended to patients already taking originator infliximab (Remicade) and originator etanercept (Enbrel). Since that time, the mandate for biosimilars has also been applied to adalimumab (Humira). For the comparison of infliximab and etanercept originators with their biosimilars, Dr. Lacaille and associates compared survivorship for the 3 years after the policy change, when patients were on biosimilars, with the 3 years prior to the change, when patients were on the originators. They compared survivorship with originator adalimumab with its biosimilars for prior to and after the switch.

”People were followed from anti-TNF [tumor necrosis factor] initiation until discontinuation for any reason,” reported Dr. Lacaille, who said data were censored for death and moving out of the province. In British Columbia, where there is universal health care, all dispensed medications can be tracked. The definition of anti-TNF discontinuation in this study was no prescription renewal for at least 6 months.

The follow-up was censored at March 2, 2020, to avoid the potential impact of COVID-19 on antirheumatic drug use. Discontinuation was standardized for the comparison of originator with biosimilar drugs as rates per 100 person-years. Statistical adjustments were made for potential confounders.

The researchers compared 1,312 patients on etanercept and 827 on a biosimilar of it, 230 patients on infliximab and 271 on a biosimilar of it, and 1,773 on adalimumab and 2,213 on a biosimilar of it. The indication was RA in approximately 60% of those on etanercept or a biosimilar and 50% of those on infliximab or adalimumab and their biosimilars. More than half of the remaining patients had indications for psoriatic arthritis, and the rest had ankylosing spondylitis.
 

No differences reach statistical significance

On the basis of discontinuation rates per 100 person-years, etanercept and its biosimilars performed almost identically (37.10 vs. 37.02, respectively). Although the discontinuation rate per 100 person-years was lower on infliximab than a biosimilar of it (29.97 vs. 37.96), the difference was not statistically significant (P = .076).

For adalimumab, the discontinuation rate was also lower on the originator drug than a biosimilar of it (32.92 vs. 36.36), but, again, this difference was also insignificant (P = .56).

When the discontinuation data were evaluated on the basis of a Cox model involving a propensity weight overlap, the univariate and the multivariable analyses found that the biosimilars had similar risks for discontinuation. Univariate analysis revealed hazard ratios for discontinuation of the biosimilar relative to the originator were 0.98 (P = .783) for etanercept, 1.17 (P = .242) for infliximab, and 1.08 (P = .09) for adalimumab. In the multivariable model, adjusted HRs for discontinuation were about the same for each of the biosimilars relative to the originator: 0.98 (P = .807) for etanercept, 1.19 (P = .183) for infliximab, and 1.08 (P = .089) for adalimumab.

Relative to previously published direct comparisons, this real-world analysis and its duration of follow-up address the limitations of formal trials. In a 2020 BMJ meta-analysis of published data from 45 trials comparing biosimilar with originator drugs in patients with RA who had failed methotrexate, the authors found only “minor differences in harms and benefits,” but they cautioned that the analysis was “hampered by a lack of long-term direct comparisons.”

In an interview, Dr. Huizinga noted that a systematic review of adalimumab biosimilars that he led 2 years ago showed that they perform comparably with the originator biologics. This and other published studies have consistently shown “that there is no difference between biologics and originators.”

Dr. Lacaille disclosed financial relationships with Fresenius Kabi, Janssen, Organon, Pfizer, and Viatris. Dr. Huizinga disclosed financial relationships with Abbott, Ablynx, Biotest, Bioscience, Boehringer Ingelheim, Bristol-Myers Squibb, Crescendo Bioscience, Eli Lilly, Galapagos, Janssen, Merck, Novartis, MycoMed, Roche, Sanofi-Aventis, Takeda, and Zydus.

Among adults with psoriatic arthritis (PsA), 11.8% required at least one musculoskeletal surgery related to their disease, based on data from more than 1,500 individuals at the University of Toronto’s Psoriatic Arthritis Clinic.

“Despite optimal medical therapy to control systemic inflammation and preserve joint function, a subset of patients with PsA still require musculoskeletal (MSK) surgery for disease-related morbidity,” but data on the prevalence of MSK surgeries and the associated risk factors are lacking, wrote Timothy S.H. Kwok, MD, of the University of Toronto, and colleagues.

In a study published in The Journal of Rheumatology, the researchers reviewed data from a longitudinal cohort of 1,574 adults aged 18 years and older with PsA established at the Toronto clinic during 1978-2019.

Overall, 185 patients had 379 MSK surgeries related to PsA during the study period for a prevalence of 11.8%.

The most common procedures were arthrodesis and arthroplasty (27% for both). More than half (59%) of the surgeries were joint sacrificing, and 41% were joint retaining, and 57 procedures were revisions related to the primary surgery.

Among 1,018 patients with data complete enough for a multivariate analysis, including 71 PsA surgeries, factors significantly associated with an increased risk for surgery were a higher number of damaged joints (hazard ratio [HR], 1.03; P < .001), tender or swollen joints (HR, 1.04; P = .01), and the presence of nail lesions (HR, 2.08; P < .01). Other predictors of surgery were higher scores on the Health Assessment Questionnaire (HR, 2.01; P < .001), elevated erythrocyte sedimentation rate (HR, 2.37; P = .02), and HLA-B27 positivity (HR, 2.22; P = .048).

However, a higher score on the Psoriasis Area Severity Index was significantly associated with lower risk of surgery (HR, 0.88; P < .002) The use of biologics had no significant impact on MSK surgery, the researchers noted.

The high percentage of joint sacrificing surgeries suggests a high burden of MSK surgery in patients with PsA, the researchers wrote in their discussion. The current study supports findings from previous studies and highlights the potential limitations and need for improvement in the current medical treatment paradigm for PsA, they said.

The findings were limited by several factors, including the potential for referral bias of complex cases to the center, which might have caused overestimation of the number of surgeries. The similarity in surgeries specifically related to PsA and degenerative arthritis also makes overestimation of surgeries possible, the researchers noted.

However, the study is one of the largest known to evaluate the prevalence of risk factors for MSK surgery in PsA patients over a long period of time, and identified surgeries directly attributable to PsA, they said. The study ended prior to the onset of the COVID-19 pandemic, which increased the external validity of the findings, they added.

The study was supported by the Krembil Foundation. The researchers had no financial conflicts to disclose.

Among adults with psoriatic arthritis (PsA), 11.8% required at least one musculoskeletal surgery related to their disease, based on data from more than 1,500 individuals at the University of Toronto’s Psoriatic Arthritis Clinic.

“Despite optimal medical therapy to control systemic inflammation and preserve joint function, a subset of patients with PsA still require musculoskeletal (MSK) surgery for disease-related morbidity,” but data on the prevalence of MSK surgeries and the associated risk factors are lacking, wrote Timothy S.H. Kwok, MD, of the University of Toronto, and colleagues.

In a study published in The Journal of Rheumatology, the researchers reviewed data from a longitudinal cohort of 1,574 adults aged 18 years and older with PsA established at the Toronto clinic during 1978-2019.

Overall, 185 patients had 379 MSK surgeries related to PsA during the study period for a prevalence of 11.8%.

The most common procedures were arthrodesis and arthroplasty (27% for both). More than half (59%) of the surgeries were joint sacrificing, and 41% were joint retaining, and 57 procedures were revisions related to the primary surgery.

Among 1,018 patients with data complete enough for a multivariate analysis, including 71 PsA surgeries, factors significantly associated with an increased risk for surgery were a higher number of damaged joints (hazard ratio [HR], 1.03; P < .001), tender or swollen joints (HR, 1.04; P = .01), and the presence of nail lesions (HR, 2.08; P < .01). Other predictors of surgery were higher scores on the Health Assessment Questionnaire (HR, 2.01; P < .001), elevated erythrocyte sedimentation rate (HR, 2.37; P = .02), and HLA-B27 positivity (HR, 2.22; P = .048).

However, a higher score on the Psoriasis Area Severity Index was significantly associated with lower risk of surgery (HR, 0.88; P < .002) The use of biologics had no significant impact on MSK surgery, the researchers noted.

The high percentage of joint sacrificing surgeries suggests a high burden of MSK surgery in patients with PsA, the researchers wrote in their discussion. The current study supports findings from previous studies and highlights the potential limitations and need for improvement in the current medical treatment paradigm for PsA, they said.

The findings were limited by several factors, including the potential for referral bias of complex cases to the center, which might have caused overestimation of the number of surgeries. The similarity in surgeries specifically related to PsA and degenerative arthritis also makes overestimation of surgeries possible, the researchers noted.

However, the study is one of the largest known to evaluate the prevalence of risk factors for MSK surgery in PsA patients over a long period of time, and identified surgeries directly attributable to PsA, they said. The study ended prior to the onset of the COVID-19 pandemic, which increased the external validity of the findings, they added.

The study was supported by the Krembil Foundation. The researchers had no financial conflicts to disclose.

Among adults with psoriatic arthritis (PsA), 11.8% required at least one musculoskeletal surgery related to their disease, based on data from more than 1,500 individuals at the University of Toronto’s Psoriatic Arthritis Clinic.

“Despite optimal medical therapy to control systemic inflammation and preserve joint function, a subset of patients with PsA still require musculoskeletal (MSK) surgery for disease-related morbidity,” but data on the prevalence of MSK surgeries and the associated risk factors are lacking, wrote Timothy S.H. Kwok, MD, of the University of Toronto, and colleagues.

In a study published in The Journal of Rheumatology, the researchers reviewed data from a longitudinal cohort of 1,574 adults aged 18 years and older with PsA established at the Toronto clinic during 1978-2019.

Overall, 185 patients had 379 MSK surgeries related to PsA during the study period for a prevalence of 11.8%.

The most common procedures were arthrodesis and arthroplasty (27% for both). More than half (59%) of the surgeries were joint sacrificing, and 41% were joint retaining, and 57 procedures were revisions related to the primary surgery.

Among 1,018 patients with data complete enough for a multivariate analysis, including 71 PsA surgeries, factors significantly associated with an increased risk for surgery were a higher number of damaged joints (hazard ratio [HR], 1.03; P < .001), tender or swollen joints (HR, 1.04; P = .01), and the presence of nail lesions (HR, 2.08; P < .01). Other predictors of surgery were higher scores on the Health Assessment Questionnaire (HR, 2.01; P < .001), elevated erythrocyte sedimentation rate (HR, 2.37; P = .02), and HLA-B27 positivity (HR, 2.22; P = .048).

However, a higher score on the Psoriasis Area Severity Index was significantly associated with lower risk of surgery (HR, 0.88; P < .002) The use of biologics had no significant impact on MSK surgery, the researchers noted.

The high percentage of joint sacrificing surgeries suggests a high burden of MSK surgery in patients with PsA, the researchers wrote in their discussion. The current study supports findings from previous studies and highlights the potential limitations and need for improvement in the current medical treatment paradigm for PsA, they said.

The findings were limited by several factors, including the potential for referral bias of complex cases to the center, which might have caused overestimation of the number of surgeries. The similarity in surgeries specifically related to PsA and degenerative arthritis also makes overestimation of surgeries possible, the researchers noted.

However, the study is one of the largest known to evaluate the prevalence of risk factors for MSK surgery in PsA patients over a long period of time, and identified surgeries directly attributable to PsA, they said. The study ended prior to the onset of the COVID-19 pandemic, which increased the external validity of the findings, they added.

The study was supported by the Krembil Foundation. The researchers had no financial conflicts to disclose.

The first biosimilar for Humira, adalimumab-atto (Amjevita), is now available in the United States, according to an announcement on Jan. 31 by the manufacturer, Amgen. At least seven other U.S. Food and Drug Administration–approved Humira biosimilars are expected to become available later in 2023.

Amjevita was approved by the FDA in September 2016 for multiple inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The delayed launch was part of a global settlement with Humira’s manufacturer, AbbVie.

Humira (adalimumab) has been available since 2002 and is consistently one of the top-selling drugs in the United States. A single 40-mg Amjevita pen device will be available at two prices: a list price (wholesale acquisition cost) of $1,557.59, 55% below the current Humira list price, and a list price of $3,288.24, 5% below the current Humira list price, according to Amgen.

“Amgen’s goal is to provide broad access for patients by offering two options to health plans and pharmacy benefit managers,” the company said in the press release.

Patients are less likely to benefit from the more significant discount, said Marta Wosinska, PhD, a health care economist at the Brookings Institute in Washington, DC. It's expected that insurance companies will use the higher list price for Amjevita, she said, as this higher price will also likely have higher rebates. Rebates are payments to health insurance payers provided by drug manufacturers to promote use of an expensive drug. Some pharmacy benefit managers have already said that they plan to charge patients the same amount for Humira as its biosimilars, Dr. Wosinska said.

"For an existing patient, there's really no incentive for them to switch," she said in an interview.

So far only one insurance company, Kaiser Permanente, has plans to switch patients over to biosimilars, according to the health policy podcast Tradeoffs, and the insurer will stop covering Humira by the end of this year.

A version of this article first appeared on Medscape.com.

*This story was updated 2/1/2023.

The first biosimilar for Humira, adalimumab-atto (Amjevita), is now available in the United States, according to an announcement on Jan. 31 by the manufacturer, Amgen. At least seven other U.S. Food and Drug Administration–approved Humira biosimilars are expected to become available later in 2023.

Amjevita was approved by the FDA in September 2016 for multiple inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The delayed launch was part of a global settlement with Humira’s manufacturer, AbbVie.

Humira (adalimumab) has been available since 2002 and is consistently one of the top-selling drugs in the United States. A single 40-mg Amjevita pen device will be available at two prices: a list price (wholesale acquisition cost) of $1,557.59, 55% below the current Humira list price, and a list price of $3,288.24, 5% below the current Humira list price, according to Amgen.

“Amgen’s goal is to provide broad access for patients by offering two options to health plans and pharmacy benefit managers,” the company said in the press release.

Patients are less likely to benefit from the more significant discount, said Marta Wosinska, PhD, a health care economist at the Brookings Institute in Washington, DC. It's expected that insurance companies will use the higher list price for Amjevita, she said, as this higher price will also likely have higher rebates. Rebates are payments to health insurance payers provided by drug manufacturers to promote use of an expensive drug. Some pharmacy benefit managers have already said that they plan to charge patients the same amount for Humira as its biosimilars, Dr. Wosinska said.

"For an existing patient, there's really no incentive for them to switch," she said in an interview.

So far only one insurance company, Kaiser Permanente, has plans to switch patients over to biosimilars, according to the health policy podcast Tradeoffs, and the insurer will stop covering Humira by the end of this year.

A version of this article first appeared on Medscape.com.

*This story was updated 2/1/2023.

The first biosimilar for Humira, adalimumab-atto (Amjevita), is now available in the United States, according to an announcement on Jan. 31 by the manufacturer, Amgen. At least seven other U.S. Food and Drug Administration–approved Humira biosimilars are expected to become available later in 2023.

Amjevita was approved by the FDA in September 2016 for multiple inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The delayed launch was part of a global settlement with Humira’s manufacturer, AbbVie.

Humira (adalimumab) has been available since 2002 and is consistently one of the top-selling drugs in the United States. A single 40-mg Amjevita pen device will be available at two prices: a list price (wholesale acquisition cost) of $1,557.59, 55% below the current Humira list price, and a list price of $3,288.24, 5% below the current Humira list price, according to Amgen.

“Amgen’s goal is to provide broad access for patients by offering two options to health plans and pharmacy benefit managers,” the company said in the press release.

Patients are less likely to benefit from the more significant discount, said Marta Wosinska, PhD, a health care economist at the Brookings Institute in Washington, DC. It's expected that insurance companies will use the higher list price for Amjevita, she said, as this higher price will also likely have higher rebates. Rebates are payments to health insurance payers provided by drug manufacturers to promote use of an expensive drug. Some pharmacy benefit managers have already said that they plan to charge patients the same amount for Humira as its biosimilars, Dr. Wosinska said.

"For an existing patient, there's really no incentive for them to switch," she said in an interview.

So far only one insurance company, Kaiser Permanente, has plans to switch patients over to biosimilars, according to the health policy podcast Tradeoffs, and the insurer will stop covering Humira by the end of this year.

A version of this article first appeared on Medscape.com.

*This story was updated 2/1/2023.

Appropriate assessment of MSK symptoms and signs by dermatologists may lead to more appropriate referral to rheumatologists. MSUS is being increasingly explored for early identification of PsA. A handheld, chip-based ultrasound device (HHUD) is a novel promising instrument that can be easily implemented in clinical practice. In a prospective study including 140 patients with psoriasis who presented to dermatologists with arthralgia. Grobelski and colleagues screened for PsA using medical history, CE, and the German Psoriasis Arthritis Diagnostic PsA screening questionnaire (GEPARD) paired with MSUS examination of up to three painful joints by trained dermatologists. Nineteen patients (13.6%) were diagnosed with PsA by rheumatologists. Interestingly, in 45 of the 46 patients the preliminary diagnosis of PsA was revised to "no PsA" after MSUS. The addition of MSUS changed the sensitivity and specificity of early PsA screening strategy from 88.2% and 54.4% to 70.6% and 90.4%, respectively. The positive predictive value increased to 56.5% from 25.4% after MSUS. Thus, the use of a quick MSUS using HHUD may lead to more accurate referral to rheumatologists. The challenge is seamless integration of MSUS into busy dermatology practices.

The goal of PsA treatment is to achieve a state of remission or low disease activity. Criteria for minimal disease activity (MDA) have been established. Achieving MDA leads to better health-related quality of life (HRQOL), as well as less joint damage. In a prospective cohort study that included 240 patients with newly diagnosed disease-modifying antirheumatic drug-naive PsA, Snoeck Henkemans and colleagues demonstrate that failure to achieve MDA in the first year after the diagnosis of PsA was associated with worse HRQOL and health status, functional impairment, fatigue, pain, and higher anxiety and depression. Compared with patients who achieved sustained MDA in the first year after diagnosis, those who did not achieve MDA had higher scores for pain, fatigue, and functional ability and higher anxiety and depression during follow-up, which persisted despite treatment intensification. Thus, implementation of treat-to-target strategies with the aim of achieving sustained MDA within 1 year of diagnosis is likely to have better long-term benefits in this lifelong disease.

Another study emphasized the need for early treatment to improve long-term outcomes. In a post hoc analysis of two phase 3 trials including 1554 patients with PsA who received 300-mg or 150-mg secukinumab with or without a loading dose, Mease and colleagues showed that high baseline radiographic damage reduced the likelihood of achieving MDA.

Overall, these studies indicate that early diagnosis and treatment prior to developing joint damage with the aim to achieve sustained MDA within a year will lead to better long-term outcome for patients with PsA.

Appropriate assessment of MSK symptoms and signs by dermatologists may lead to more appropriate referral to rheumatologists. MSUS is being increasingly explored for early identification of PsA. A handheld, chip-based ultrasound device (HHUD) is a novel promising instrument that can be easily implemented in clinical practice. In a prospective study including 140 patients with psoriasis who presented to dermatologists with arthralgia. Grobelski and colleagues screened for PsA using medical history, CE, and the German Psoriasis Arthritis Diagnostic PsA screening questionnaire (GEPARD) paired with MSUS examination of up to three painful joints by trained dermatologists. Nineteen patients (13.6%) were diagnosed with PsA by rheumatologists. Interestingly, in 45 of the 46 patients the preliminary diagnosis of PsA was revised to "no PsA" after MSUS. The addition of MSUS changed the sensitivity and specificity of early PsA screening strategy from 88.2% and 54.4% to 70.6% and 90.4%, respectively. The positive predictive value increased to 56.5% from 25.4% after MSUS. Thus, the use of a quick MSUS using HHUD may lead to more accurate referral to rheumatologists. The challenge is seamless integration of MSUS into busy dermatology practices.

The goal of PsA treatment is to achieve a state of remission or low disease activity. Criteria for minimal disease activity (MDA) have been established. Achieving MDA leads to better health-related quality of life (HRQOL), as well as less joint damage. In a prospective cohort study that included 240 patients with newly diagnosed disease-modifying antirheumatic drug-naive PsA, Snoeck Henkemans and colleagues demonstrate that failure to achieve MDA in the first year after the diagnosis of PsA was associated with worse HRQOL and health status, functional impairment, fatigue, pain, and higher anxiety and depression. Compared with patients who achieved sustained MDA in the first year after diagnosis, those who did not achieve MDA had higher scores for pain, fatigue, and functional ability and higher anxiety and depression during follow-up, which persisted despite treatment intensification. Thus, implementation of treat-to-target strategies with the aim of achieving sustained MDA within 1 year of diagnosis is likely to have better long-term benefits in this lifelong disease.

Another study emphasized the need for early treatment to improve long-term outcomes. In a post hoc analysis of two phase 3 trials including 1554 patients with PsA who received 300-mg or 150-mg secukinumab with or without a loading dose, Mease and colleagues showed that high baseline radiographic damage reduced the likelihood of achieving MDA.

Overall, these studies indicate that early diagnosis and treatment prior to developing joint damage with the aim to achieve sustained MDA within a year will lead to better long-term outcome for patients with PsA.

Appropriate assessment of MSK symptoms and signs by dermatologists may lead to more appropriate referral to rheumatologists. MSUS is being increasingly explored for early identification of PsA. A handheld, chip-based ultrasound device (HHUD) is a novel promising instrument that can be easily implemented in clinical practice. In a prospective study including 140 patients with psoriasis who presented to dermatologists with arthralgia. Grobelski and colleagues screened for PsA using medical history, CE, and the German Psoriasis Arthritis Diagnostic PsA screening questionnaire (GEPARD) paired with MSUS examination of up to three painful joints by trained dermatologists. Nineteen patients (13.6%) were diagnosed with PsA by rheumatologists. Interestingly, in 45 of the 46 patients the preliminary diagnosis of PsA was revised to "no PsA" after MSUS. The addition of MSUS changed the sensitivity and specificity of early PsA screening strategy from 88.2% and 54.4% to 70.6% and 90.4%, respectively. The positive predictive value increased to 56.5% from 25.4% after MSUS. Thus, the use of a quick MSUS using HHUD may lead to more accurate referral to rheumatologists. The challenge is seamless integration of MSUS into busy dermatology practices.

The goal of PsA treatment is to achieve a state of remission or low disease activity. Criteria for minimal disease activity (MDA) have been established. Achieving MDA leads to better health-related quality of life (HRQOL), as well as less joint damage. In a prospective cohort study that included 240 patients with newly diagnosed disease-modifying antirheumatic drug-naive PsA, Snoeck Henkemans and colleagues demonstrate that failure to achieve MDA in the first year after the diagnosis of PsA was associated with worse HRQOL and health status, functional impairment, fatigue, pain, and higher anxiety and depression. Compared with patients who achieved sustained MDA in the first year after diagnosis, those who did not achieve MDA had higher scores for pain, fatigue, and functional ability and higher anxiety and depression during follow-up, which persisted despite treatment intensification. Thus, implementation of treat-to-target strategies with the aim of achieving sustained MDA within 1 year of diagnosis is likely to have better long-term benefits in this lifelong disease.

Another study emphasized the need for early treatment to improve long-term outcomes. In a post hoc analysis of two phase 3 trials including 1554 patients with PsA who received 300-mg or 150-mg secukinumab with or without a loading dose, Mease and colleagues showed that high baseline radiographic damage reduced the likelihood of achieving MDA.

Overall, these studies indicate that early diagnosis and treatment prior to developing joint damage with the aim to achieve sustained MDA within a year will lead to better long-term outcome for patients with PsA.

Fluorescence-optical imaging (FOI) identified early signs of psoriatic arthritis, based on data from 2 years of follow-up of a cohort of 389 adults at 14 rheumatology centers.

Approximately 25% of individuals with psoriasis go on to develop psoriatic arthritis (PsA), but there are no validated biomarkers to identify patients at risk for progression to PsA, Michaela Koehm, MD, of Goethe University, Frankfurt am Main, Germany, and colleagues wrote in RMD Open.

FOI is a technique that allows assessment of changes in microvascularization and subdermal skin inflammation, and because individuals with psoriasis who develop PsA have shown changes in blood vessel formation in the early stages of disease, the researchers sought to determine if FOI could be used to predict early PsA.

The researchers conducted a multicenter, two-part observational cohort study. The two parts, known as XCITING and XTEND, included 389 adults aged 18-75 years with plaque psoriasis deemed at increased risk for PsA. The patients were seen at rheumatology sites in Germany between Jan. 28, 2014, and March 16, 2017. The XTEND study included clinic visits 18-24 months after the XCITING study.

Participants underwent a complete clinical examination, with musculoskeletal ultrasound (MSUS) and FOI on both hands at a single visit. Those with positive FOI findings not seen with clinical exam or MSUS underwent MRI within 7 days. Patients with positive FOI but negative findings on clinical exam, MSUS, and MRI were followed for 2 years in the XTEND study.

The primary outcome was the ability of FOI to detect musculoskeletal inflammation, compared with clinical examination and MSUS.

Overall, 50% of the patients were diagnosed with PsA. A total of 116 (30%) had positive FOI findings; complete MRI data were available for 108 of these patients, including 68 negative MRIs and 40 positive MRIs.

In the XTEND study, another 12% of patients who were positive on FOI but not on MRI also developed PsA by the end of the 2-year follow-up. In comparison, the researchers noted that “literature data on yearly incidence rates [of PsA] in different national cohorts indicate an incidence rate of approximately 4.3% per year.”

A total of 149 of the 196 patients with PsA confirmed by either clinical exam or MSUS were also positive on FOI, yielding a sensitivity of 76.0%. The specificity of FOI was 39.5%.

The sensitive visualization of musculoskeletal inflammation possible with FOI “may exceed its ability to detect clinically manifest PsA at high sensitivity or specificity, but early visualization is arguably of greater value as other imaging methods are currently available for detection of later stages of PsA,” the researchers wrote in their discussion. “A technique allowing early identification of PsA may be especially valuable for nonrheumatologists, including dermatologists and general practitioners, and help expedite more efficient referral to specialists.”

The findings were limited by several factors, including the nonrandomized design and small subgroup numbers, the researchers noted. Other limitations include the presence of alternative conditions such as osteoarthritis that might have complicated the imaging; the focus only on the hands; and potential variation in FOI assessment related to technical standards such as temperature and positioning.

However, the results support FOI as a safe and effective method of detecting early signs of joint inflammation that could predict increased risk for PsA in psoriasis patients, the researchers said.

The researchers added that more work is needed to evaluate FOI in clinical practice, but FOI has the potential to identify vascularization changes earlier than other imaging modalities and in advance of clinical symptoms.

“Accordingly, FOI may have the potential to improve patient outcomes in PsA by reducing the time to initiation of early treatment,” they concluded.

The study was supported by Fraunhofer ITMP, a nonprofit organization, and a research grant from Pfizer Germany. Some of the researchers disclosed financial relationships with many pharmaceutical companies, including Pfizer.

Fluorescence-optical imaging (FOI) identified early signs of psoriatic arthritis, based on data from 2 years of follow-up of a cohort of 389 adults at 14 rheumatology centers.

Approximately 25% of individuals with psoriasis go on to develop psoriatic arthritis (PsA), but there are no validated biomarkers to identify patients at risk for progression to PsA, Michaela Koehm, MD, of Goethe University, Frankfurt am Main, Germany, and colleagues wrote in RMD Open.

FOI is a technique that allows assessment of changes in microvascularization and subdermal skin inflammation, and because individuals with psoriasis who develop PsA have shown changes in blood vessel formation in the early stages of disease, the researchers sought to determine if FOI could be used to predict early PsA.

The researchers conducted a multicenter, two-part observational cohort study. The two parts, known as XCITING and XTEND, included 389 adults aged 18-75 years with plaque psoriasis deemed at increased risk for PsA. The patients were seen at rheumatology sites in Germany between Jan. 28, 2014, and March 16, 2017. The XTEND study included clinic visits 18-24 months after the XCITING study.

Participants underwent a complete clinical examination, with musculoskeletal ultrasound (MSUS) and FOI on both hands at a single visit. Those with positive FOI findings not seen with clinical exam or MSUS underwent MRI within 7 days. Patients with positive FOI but negative findings on clinical exam, MSUS, and MRI were followed for 2 years in the XTEND study.

The primary outcome was the ability of FOI to detect musculoskeletal inflammation, compared with clinical examination and MSUS.

Overall, 50% of the patients were diagnosed with PsA. A total of 116 (30%) had positive FOI findings; complete MRI data were available for 108 of these patients, including 68 negative MRIs and 40 positive MRIs.

In the XTEND study, another 12% of patients who were positive on FOI but not on MRI also developed PsA by the end of the 2-year follow-up. In comparison, the researchers noted that “literature data on yearly incidence rates [of PsA] in different national cohorts indicate an incidence rate of approximately 4.3% per year.”

A total of 149 of the 196 patients with PsA confirmed by either clinical exam or MSUS were also positive on FOI, yielding a sensitivity of 76.0%. The specificity of FOI was 39.5%.

The sensitive visualization of musculoskeletal inflammation possible with FOI “may exceed its ability to detect clinically manifest PsA at high sensitivity or specificity, but early visualization is arguably of greater value as other imaging methods are currently available for detection of later stages of PsA,” the researchers wrote in their discussion. “A technique allowing early identification of PsA may be especially valuable for nonrheumatologists, including dermatologists and general practitioners, and help expedite more efficient referral to specialists.”

The findings were limited by several factors, including the nonrandomized design and small subgroup numbers, the researchers noted. Other limitations include the presence of alternative conditions such as osteoarthritis that might have complicated the imaging; the focus only on the hands; and potential variation in FOI assessment related to technical standards such as temperature and positioning.

However, the results support FOI as a safe and effective method of detecting early signs of joint inflammation that could predict increased risk for PsA in psoriasis patients, the researchers said.

The researchers added that more work is needed to evaluate FOI in clinical practice, but FOI has the potential to identify vascularization changes earlier than other imaging modalities and in advance of clinical symptoms.

“Accordingly, FOI may have the potential to improve patient outcomes in PsA by reducing the time to initiation of early treatment,” they concluded.

The study was supported by Fraunhofer ITMP, a nonprofit organization, and a research grant from Pfizer Germany. Some of the researchers disclosed financial relationships with many pharmaceutical companies, including Pfizer.

Fluorescence-optical imaging (FOI) identified early signs of psoriatic arthritis, based on data from 2 years of follow-up of a cohort of 389 adults at 14 rheumatology centers.

Approximately 25% of individuals with psoriasis go on to develop psoriatic arthritis (PsA), but there are no validated biomarkers to identify patients at risk for progression to PsA, Michaela Koehm, MD, of Goethe University, Frankfurt am Main, Germany, and colleagues wrote in RMD Open.

FOI is a technique that allows assessment of changes in microvascularization and subdermal skin inflammation, and because individuals with psoriasis who develop PsA have shown changes in blood vessel formation in the early stages of disease, the researchers sought to determine if FOI could be used to predict early PsA.

The researchers conducted a multicenter, two-part observational cohort study. The two parts, known as XCITING and XTEND, included 389 adults aged 18-75 years with plaque psoriasis deemed at increased risk for PsA. The patients were seen at rheumatology sites in Germany between Jan. 28, 2014, and March 16, 2017. The XTEND study included clinic visits 18-24 months after the XCITING study.

Participants underwent a complete clinical examination, with musculoskeletal ultrasound (MSUS) and FOI on both hands at a single visit. Those with positive FOI findings not seen with clinical exam or MSUS underwent MRI within 7 days. Patients with positive FOI but negative findings on clinical exam, MSUS, and MRI were followed for 2 years in the XTEND study.

The primary outcome was the ability of FOI to detect musculoskeletal inflammation, compared with clinical examination and MSUS.

Overall, 50% of the patients were diagnosed with PsA. A total of 116 (30%) had positive FOI findings; complete MRI data were available for 108 of these patients, including 68 negative MRIs and 40 positive MRIs.

In the XTEND study, another 12% of patients who were positive on FOI but not on MRI also developed PsA by the end of the 2-year follow-up. In comparison, the researchers noted that “literature data on yearly incidence rates [of PsA] in different national cohorts indicate an incidence rate of approximately 4.3% per year.”

A total of 149 of the 196 patients with PsA confirmed by either clinical exam or MSUS were also positive on FOI, yielding a sensitivity of 76.0%. The specificity of FOI was 39.5%.

The sensitive visualization of musculoskeletal inflammation possible with FOI “may exceed its ability to detect clinically manifest PsA at high sensitivity or specificity, but early visualization is arguably of greater value as other imaging methods are currently available for detection of later stages of PsA,” the researchers wrote in their discussion. “A technique allowing early identification of PsA may be especially valuable for nonrheumatologists, including dermatologists and general practitioners, and help expedite more efficient referral to specialists.”

The findings were limited by several factors, including the nonrandomized design and small subgroup numbers, the researchers noted. Other limitations include the presence of alternative conditions such as osteoarthritis that might have complicated the imaging; the focus only on the hands; and potential variation in FOI assessment related to technical standards such as temperature and positioning.

However, the results support FOI as a safe and effective method of detecting early signs of joint inflammation that could predict increased risk for PsA in psoriasis patients, the researchers said.

The researchers added that more work is needed to evaluate FOI in clinical practice, but FOI has the potential to identify vascularization changes earlier than other imaging modalities and in advance of clinical symptoms.

“Accordingly, FOI may have the potential to improve patient outcomes in PsA by reducing the time to initiation of early treatment,” they concluded.

The study was supported by Fraunhofer ITMP, a nonprofit organization, and a research grant from Pfizer Germany. Some of the researchers disclosed financial relationships with many pharmaceutical companies, including Pfizer.