This appendix describes in detail the effectiveness evidence and cost information on apremilast, JAK inhibitors and biologic therapies for psoriatic arthritis. The selection of the effectiveness evidence had following steps: the literature search and selection of effectiveness evidence, quality appraisal and crosscheck with Current Care Guideline evidence summaries. We chose the network meta-analysis by Mease et al. (2024) as the base of the effectiveness evidence. The effectiveness evidence is only for biologic and targeted synthetic naïve patient populations. Table 3 describe the studies included in the Mease et al. (2024) network meta-analysis.
Source of the effectiveness evidenceMease et al. 2024. Comparative efficacy and safety of bimekizumab in psoriatic arthritis: a systematic literature review and network meta-analysis. Rheumatology (Oxford). doi: 10.1093/rheumatology/kead705.
The literature search of network meta-analyses (NMA) has been conducted in two phases. The original literature search was done by information specialist in March 2022. The search included network meta-analyses, meta-analyses and systematic reviews of systemic therapies for psoriatic arthritis. We searched for the most recent evidence by viewing only network meta-analyses published in 2022 and 2021, if satisfactory number of comprehensive studies were found. A total of four network meta-analyses were published in 2022 and 2021. We updated the literature search in March 2024 and found two network meta-analyses published in 2023 and 2024. (Table «Description of the network meta-analyses of systemic therapies for psoriatic arthritis published between 2021–2024....»1).
| Citation | Research aim | Number of trials, date of literature search | ACR-50 outcome measure | Interventions | Comments |
|---|---|---|---|---|---|
| Mease et al. 2024 «Mease PJ, Gladman DD, Merola JF, ym. Comparative e...»2 | To understand the relative efficacy and safety of bimekizumab, a selective inhibitor of interleukin-17F in addition to IL-17A, vs other biologic and b/tsDMARDs for PsA using network meta-analysis. | 41 RCTs. May 2022 and update January 2023. |
Yes | abatacept, adalimumab, apremilast, bimekizumab, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, risankizumab, secukinumb, tofacitinib, upadacitinib, ustekinumab. | Comprehensive, includes all selected interventions. Also new interventions risankizumab and bimekizumab. |
| McInnes et al. 2022 «McInnes IB, Sawyer LM, Markus K, ym. Targeted syst...»1 | To compare the efficacy and safety of all evaluated DMARDs for active PsA, with a special focus on biological DMARDs (bDMARDs) licensed for PsA or psoriasis. | 46 RCTs. March 2020 and update August 2020. |
Yes | abatacept, adalimumab, apremilast, bimekizumab, brodalumab, certolizumab pegol, etanercept, filgotinib, golimumab, guselkumab, infliximab, ixekizumab, netakimab, risankizumab, secukinumab, tildrakizumab, tofacitinib, upadacitinib and ustekinumab. Both monotherapies and combination therapies. | Comprehensive, includes all selected interventions. Subgroup analyses for biologic drug naïve and biologic drug exposed. |
| Mease et al. 2021 «Mease PJ, McInnes IB, Tam LS, ym. Comparative effe...»3 | To compare guselkumab to targeted therapies for PsA for safety and joint and skin efficacy through network meta-analysis. | 26 RCTs. October 2018 and update in January 2020. |
Yes | abatacept, adalimumab, apremilast, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, secukinumab, ustekinumab, tofacitinib. | Only 12 interventions from selected 14 interventions. Does not include upadacitinib and brodalumab as the effectiveness studies are published before the literature search by Mease et al. |
| Montezuma et al. 2024 «Montezuma T, Probst LF, Almeida MO. Effectiveness ...»4 | To determine the effectiveness and safety of biological and target synthetic drugs for treating psoriatic arthritis. | 33 RCTs February 2022. |
Yes | adalimumab, certolizumab pegol, etarnesept, golimumab, infliximab, secukinumb, tofacitinib. |
Only seven interventions included. |
| Song et al. 2021 «Song GG, Lee YH. Comparative efficacy and safety o...»5 | To determine the relative effectiveness and safety of secukinumab, ixekizumab, and tofacitinib in patients with psoriatic arthritis. | 6 RCTs. Not known the date of the search. |
Not known. | Ixekizumab, secukinumab, tofacitinib. | Only three interventions included. |
| Song et al. 2021 «Song GG, Lee YH. Relative efficacy and safety of s...»6 | A Bayesian network meta-analysis was performed incorporating data from RCTs to evaluate the effectiveness and safety of secukinumab 150 mg, secukinumab 300 mg, and guselkumab 100 mg every 4 weeks and guselkumab every 8 weeks. | 6 RCTs. Not known the date of the search. |
Not known. | guselkumab, secukinumab. | Only two interventions included. |
From the first literature search, we selected two studies (McInnes et al. 2022 «McInnes IB, Sawyer LM, Markus K, ym. Targeted syst...»1; Mease et al. 2021 «Mease PJ, McInnes IB, Tam LS, ym. Comparative effe...»3) for further examination. McInnes et al. (2022) «McInnes IB, Sawyer LM, Markus K, ym. Targeted syst...»1 was the most recent, comprehensive, included all selected interventions and reported the effectiveness outcome (ACR50) selected by the Current Care working group. Mease et al. (2021) «Mease PJ, McInnes IB, Tam LS, ym. Comparative effe...»3 was also recently published, relatively comprehensive by included almost all selected interventions and reported the effectiveness outcome (ACR50) selected by the Current Care working group.
In 2024 literature search, we selected Mease et al. (2024) «Mease PJ, Gladman DD, Merola JF, ym. Comparative e...»2 for further examinations as it was only one including all selected interventions.
We evaluated the quality of the McInnes et al. (2022) «McInnes IB, Sawyer LM, Markus K, ym. Targeted syst...»1 and Mease et al. (2021; 2024) «Mease PJ, Gladman DD, Merola JF, ym. Comparative e...»2, «Mease PJ, McInnes IB, Tam LS, ym. Comparative effe...»3 network meta-analyses by using AMSTAR 2 (Shea et al.. 2017) «Shea BJ, Reeves BC, Wells G, ym. AMSTAR 2: a criti...»7. The results of the quality appraisal are shown in Table «Critical appraisal of selected network meta-analyses by using AMSTAR 2 (Shea et al. 2017) ...»2.
We also crosschecked the two network meta-analyses with Current Care Guideline evidence summaries to evaluate the comprehensiveness of the network meta-analyses. Compared to evidence summaries, the studies by McInnes et al. (2022) «McInnes IB, Sawyer LM, Markus K, ym. Targeted syst...»1 and Mease et al. (2024) «Mease PJ, Gladman DD, Merola JF, ym. Comparative e...»2 had few differences. McInnes et al. (2022) «McInnes IB, Sawyer LM, Markus K, ym. Targeted syst...»1 included all except two studies (Wells et al. 2018; Mease et al. 2000) included in the evidence summaries. Mease et al. (2024) «Mease PJ, Gladman DD, Merola JF, ym. Comparative e...»2 lacked eight studies compared to evidence summaries (Wells et al. 2018; Mease et al. 2019; Deodhar et al. 2018; Mease et al. 2020; Mease et al. 2015; Baraliakos et al. 2021; Mease et al. 2021; Mease et al. 2021;).
Mease et al. (2024) «Mease PJ, Gladman DD, Merola JF, ym. Comparative e...»2 included seven studies which were not included in the McInnes et. al. (2022): Ritchlin et al. (2020), Mease et al. (2022), Merola et al. (2023), Ostor et al. (2022), Kristensen et al. (2022), McInnes et al. (2023) and Mease et al. (2000). All of those, expect Mease et al. (2000), are RCT-studies of new interventions risankizumab and bimekizumab. McInnes et al. (2022) «McInnes IB, Sawyer LM, Markus K, ym. Targeted syst...»1 included three studies which were not included in the Mease et al. (2024) because of differences in interventions (Baranauskaite et al. 2012; Mease et. al. 2018; Schett et al. 2012). In three studies, the reason for the exclusion was unclear (Gottlieb et al. 2009; Deodhar et al. 2018; Sterry et al. 2010).
| Question | McInnes et al. 2022 «McInnes IB, Sawyer LM, Markus K, ym. Targeted syst...»1 | Mease et al. 2021 «Mease PJ, McInnes IB, Tam LS, ym. Comparative effe...»3 | Mease et al. 2024 «Mease PJ, Gladman DD, Merola JF, ym. Comparative e...»2 | |||
|---|---|---|---|---|---|---|
| Answer | Comments | Answer | Comments | Answer | Comments | |
| Did the research questions and inclusion criteria for the review include the components of PICO? | Yes | Yes | Yes | |||
| Did the report of the review contain an explicit statement that the review methods were established prior to the conduct of the review and did the report justify any significant deviations from the protocol? | No | No written protocol or guide cited. | Yes | Partial yes | The authors refer to previous versions of NMA (2015, with updates in January 2020 and May 2022). |
|
| Did the review authors explain their selection of the study designs for inclusion in the review? | Yes | Yes | Yes | |||
| Did the review authors use a comprehensive literature search strategy? | Yes | Yes | Yes | |||
| Did the review authors perform study selection in duplicate? | No | The titles and abstracts were assessed for inclusion by one reviewer, with another reviewer performing a 40% check. The percentage of the agreement not shown. | Yes | Yes | ||
| Did the review authors perform data extraction in duplicate? | Yes | Yes | No | |||
| Did the review authors provide a list of excluded studies and justify the exclusions? | Partial yes |
No reference list of excluded studies with justification for exclusion. Justifications for exclusions reported in the PRISMA diagram. | Partial yes | No reference list of excluded studies with justification for exclusion. Justifications for exclusions reported in the PRISMA diagram. | Yes | |
| Did the review authors describe the included studies in adequate detail? | Yes | Partial yes | Study did not describe sample sizes by trial arms. | Partial yes | Study did not describe population in detail and timeframe for follow-up. | |
| Did the review authors use a satisfactory technique for assessing the risk of bias (RoB) in individual studies that were included in the review? | Yes | Yes | Yes | |||
| Did the review authors report on the sources of funding for the studies included in the review? | Yes | No | Study did not report the sources of funding of the included studies. | No | Study did not report the sources of funding of the included studies. | |
| If meta-analysis was performed did the review authors use appropriate methods for statistical combination of results? | Yes | Yes | Yes | |||
| If meta-analysis was performed, did the review authors assess the potential impact of RoB in individual studies on the results of the meta-analysis or other evidence synthesis? | No | Included all RCTs regardless of the RoB and did not perform analyses to investigate possible impact of RoB on estimates. | Yes | No | According to the authors trials with high RoB were not identified. The supplementary table S4 shows that there's unclear risk in some trials. |
|
| Did the review authors account for RoB in individual studies when interpreting/ discussing the results of the review? | No | Included all RCTs regardless of the RoB and did not discuss the likely impact of the RoB on the results. | Yes | No | Included all RCTs regardless of the RoB and did not discuss the likely impact of the RoB on the results. | |
| Did the review authors provide a satisfactory explanation for, and discussion of, any heterogeneity observed in the results of the review? | Yes | Yes | Yes | |||
| If they performed quantitative synthesis, did the review authors carry out an adequate investigation of publication bias (small study bias) and discuss its likely impact on the results of the review? | No | Did not perform graphical or statistical tests for publication bias and discuss the likelihood and magnitude of impact of publication bias. | No | Did not perform graphical or statistical tests for publication bias and discuss the likelihood and magnitude of impact of publication bias. | No | Did not perform graphical or statistical tests for publication bias and discuss the likelihood and magnitude of impact of publication bias. |
| Did the review authors report any potential sources of conflict of interest, including any funding they received for conducting the review? | No | Study was industry funded and did not describe how they managed potential conflict of interest. | No | Study was industry funded and did not describe how they managed potential conflict of interest. | Yes | Study was industry funded in accordance with Good Publication Practice (GPP 2022) guidelines. |
| Summary of the quality | Yes n=9 Partial yes n=1 No n=6 |
Yes n=11 Partial yes n=2 No n=3 |
Yes n=9 Partial yes n=2 No n=5 |
|||
We chose the network meta-analysis by Mease et al. (2024) as the base of our effectiveness estimates as it was the most comprehensive study by including all the selected interventions. The crosscheck with the evidence summaries showed that the Mease et al. (2024) included comprehensively relevant effectiveness studies. The study followed the same methods as the previous published versions of the network meta-analyses. The study did not report the sources of funding of the included studies. The RoB of the original RCTs was unclear as the authors stated that they did not identify any trials with high RoB. Still, the supplementary showed that there's unclear risk in some trials. They did not assess and discuss the potential impact of RoB in individual studies on their results.
The Mease et al. (2024) «Mease PJ, Gladman DD, Merola JF, ym. Comparative e...»2 reported ORs and 95% Cls of ACR50 response and for the Current Care working group's selected interventions. We converted the ORs to NNTs (Schünemann et al. 2022) «Schünemann HJ, Vist GE, Higgins JPT et al. Chapter...»8. Assumed comparator risk of the naïve patient population is from McInnes et. al. (2022) «McInnes IB, Sawyer LM, Markus K, ym. Targeted syst...»1. Network meta-analysis by Mease et al. (2024) «Mease PJ, Gladman DD, Merola JF, ym. Comparative e...»2 included 41 RCTs of selected interventions which also reported ACR50 results. The characteristics of RCTs are presented in the table 3. The PsA related inclusion criteria varied between studies. Also, the study duration varied and was between 12-16 weeks.
| Study | Interventions and comparators (n; prior b/tsDMARD-naïve %) | Study duration (weeks) | PsA related inclusion criteria |
|---|---|---|---|
| ASTRAEA Mease et al. 2017 |
Placebo (n=211; 38,4%), Abatacept 125 mg (n=213; 39,4%) |
16 | CASPAR criteria; ≥3 swollen joints and ≥3 tender joints; Active plaque PsO with ≥1 qualifying target lesion ≥2 cm in diameter |
| ADEPT Mease et al. 2005 |
Placebo (n=162; 100%), Adalimumab 40 mg (n=153; 100%) |
12 | ≥3 swollen joints and ≥3 tender joints or painful joints; either active psoriatic skin lesions or a documented history of PsO |
| Genovese et al. 2007 | Placebo (n=51; 100%), Adalimumab 40 mg (n=51,100%) |
12 | ≥3 swollen joints and ≥3 tender joints; either an active psoriatic skin lesion of chronic plaque PsO or a documented history of chronic plaque PsO diagnosed by the investigator or a dermatologist |
| ACTIVE Nash et al. 2018 |
Placebo (n=109; 100%), Apremilast 30 mg twice daily (n=110; 100%) |
16 | ≥3 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints; CRP ≥0.2 mg/dL |
| PALACE 1 Kavanaugh et al. 2014 |
Placebo (n=168; 75,6%), Apremilast 20 mg twice daily (n=168; 78%), Apremilast 30 mg twice daily (n=168; 75,8%) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints |
| PALACE 2 Cutolo et al. 2016 |
Placebo (n=159; 85,5%), Apremilast 20 mg twice daily (n=163; 82,8%), Apremilast 30 mg twice daily (n=162; 85,8%) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints |
| PALACE 3 Edwards et al. 2016 |
Placebo (n=169; 72%), Apremilast 20 mg twice daily (n=169; 70%), Apremilast 30 mg twice daily (n=167; 74%) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints; active PsO with ≥1 plaque PsO skin lesion ≥2 cm in size |
| RAPID-PsA Mease et al. 2014 |
Placebo (n=136;80,9%), Certolizumab 200 mg every two weeks (n=138; 77,5%), Certolizumab 400 mg every four weeks (n=135; 83%) |
12 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints; either ESR ≥28 mm/h (Westergren) or CRP >upper limit of normal (7.9 mg/L), and have active psoriatic skin lesions or a documented history of PsO |
| Mease et al. 2004 | Placebo (n=104; 100%), Etanercept 25 mg twice weekly (n=101; 100%) |
12 | Moll & Wright criteria; ≥3 swollen joints and ≥3 tender joints; ≥1 clinical subtype of PsA (DIP joint involvement, polyarticular arthritis, arthritis mutilans, asymmetric peripheral arthritis, or ankylosing spondylitis-like arthritis); stable plaque PsO with skin lesion ≥2 cm in diameter |
| GO-REVEAL Kavanaugh et al. 2009 |
Placebo (n=113; 100%), Golimumab 50 mg (n=146; 100%), Golimumab 100 mg (n=146; 100%) |
14 | ≥6 months diagnosis; ≥3 swollen and ≥3 tender joints; ≥1 subset of PsA and the presence of plaque PsO with a qualifying lesion ≥2 cm in diameter; RF- |
| GO-VIBRANT Kavanaugh et al. 2017 |
Placebo (n=239; 100%), Golimumab 2mg/kg (n=241; 100%) |
14 | ≥6 months diagnosis; CASPAR criteria; ≥5 swollen and ≥5 tender; high-sensitivity CRP level of ≥0.6 mg/dl at screening despite current or previous DMARD therapy and/or NSAID therapy, or demonstrate intolerance to these agents |
| DISCOVER 1 Deodhar et al. 2020 |
Placebo (n=126; 69%), Guselkumab 100 mg every eight weeks (n=128;68%), Guselkumab 100 mg every four weeks (n=128; 70%) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen and ≥3 tender joints; CRP concentration of ≥0.3 mg/dL; ≥1 PsA subset: DIP joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis |
| DISCOVER 2 Mease et al. 2020 |
Placebo (n=247; 100%), Guselkumab 100 mg every eight weeks (n=248; 100%), Guselkumab 100 mg every four weeks (n=246; 100%) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen and ≥3 tender joints; ≥5 swollen and ≥5 tender joints; CRP concentration of ≥0.6 mg/dL; current or documented history of PsO; ≥1 PsA subset: DIP joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis |
| IMPACT Antoni et al. 2005 |
Placebo (n=52; 100%), Infliximab 5 mg/kg (n=52; 100%) |
16 | ≥6 months diagnosis; ≥5 swollen and ≥5 tender joints; active peripheral polyarticular arthritis in conjunction with ≥1 of the following criteria: ESR ≥28 mm/h, CRP level ≥15 mg/L, and/or morning stiffness lasting ≥45 minutes |
| IMPACT 2 Antoni et al. 2005 |
Placebo (n=100; 100%), Infliximab 5 mg/kg (n=100; 100%) |
14 | ≥6 months diagnosis; ≥5 swollen and ≥5 tender joints; either CRP levels of ≥15 mg/L and/or morning stiffness lasting ≥45 minutes; active plaque PsO with ≥1 qualifying target lesion ≥2 cm in diameter; RF- |
| SPIRIT H2H Mease et al. 2020 |
Adalimumab 40 mg (n=283; 100%), Ixekizumab 80 mg (n=283; 100%) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen and ≥3 tender joints; Active psoriatic skin lesions of plaque PsO with a BSA ≥3%; RF- |
| SPIRIT P1 Mease et al. 2017 |
Placebo (n=106; 100%), Adalimumab 40 mg (n=101; 100%), Ixekizumab 80 mg every four weeks (n=107; 100%), Ixekizumab 80 mg every two weeks (n=103; 100%) |
12 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints; either ≥1 PsA-related hand or foot joint erosion on centrally read Xrays or CRP >6 mg/L; RF- |
| SPIRIT P2 Nash et al. 2017 |
Placebo (n=118; 0%), Ixekizumab 80 mg every four weeks (n=122; 0%), Ixekizumab 80 mg every two weeks (n=123; 0%) |
12 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints; RF- Have active psoriatic skin lesions or a documented history of plaque PsO |
| CHOICE Nguyen et al. 2019 |
Placebo (n=52; 100%), Secukinumab 150 mg (n=103;100%), Secukinumab 300 mg (n=103;100%) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints; Target skin psoriatic lesion and a PASI score of ≥1 |
| FUTURE 1 Mease et al. 2015 |
Placebo (n=202; 70,8%), Secukinumab 75 mg (IV LD) (n=202; 70,3%), Secukinumab 150 mg (IV LD) (n=202; 70,8%) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints; Active plaque PsO, with ≥1 psoriatic plaque of ≥2 cm diameter (but not in intertriginous areas such as armpits, or chest between breasts, or groin) or nail changes consistent with PsO or a documented history of plaque PsO |
| FUTURE 2 McInnes et al. 2015 |
Placebo (n=98; 65%), Secukinumab 75 mg (SC LD) (n=99; 66%), Secukinumab 150 mg (n=100; 63%), Secukinumab 300 mg (n=100; 67%) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints; active plaque PsO, nail changes consistent with PsO, or a documented history of plaque PsO |
| FUTURE 3 Nash et al. 2018 |
Placebo (n=137; 67,9%), Secukinumab 150 mg (n=138; 68,2%), Secukinumab 300 mg (n=139; 68,3%) |
16 | CASPAR criteria; ≥3 swollen joints and ≥3 tender joints |
| FUTURE 4 Kvitz et al. 2019 |
Placebo (n=114; 76,3%), Secukinumab 150 mg (no LD) (n=113; 76%), Secukinumab 150 mg (n=114; 76,3%) |
16 | CASPAR criteria; ≥3 swollen joints and ≥3 tender joints; |
| FUTURE 5 Mease et al. 2018 |
Placebo (n=332; 70,5%), Secukinumab 150 mg (no LD) (n=222; 71,2%), Secukinumab 150 mg (n=220; 70,5%), Secukinumab 300 mg (n=222; 69,3%) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints; |
| EXCEED McInnes et al. 2020 |
Adalimumab 40 mg (n=427; 100%), Secukinumab 300 mg (n=426; 100%) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints; active plaque PsO with ≥1 plaque of ≥2 cm diameter or nail changes consistent with PsO or documented history of plaque PsO |
| OPAL BEYOND Gladman et al. 2017 |
Placebo (n=131; 0%), Tofacitinib 5 mg twice daily (n=131; 0%), Tofacitinib 10 mg twice daily (n=132; 0%) |
13 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender or painful joints; active plaque PsO (diagnosed or confirmed by a dermatologist or a sponsor approved rheumatologist) |
| OPAL BROADEN Mease et al. 2017 |
Placebo (n=105;97%), Adalimumab 40 mg (n=106; 99%), Tofacitinib 5 mg twice daily (n=107; 97%), Tofacitinib 10 mg twice daily (n=104; 96%) |
13 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints |
| SELECT-PsA 1 McInnes et al. 2020 |
Placebo (n=423; NR), Upadacitinib 15 mg once daily (n=429; NR), Upadacitinib 30 mg once daily (n=423; NR), Adalimumab 40 mg (n=429;NR) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints |
| SELECT-PsA 2 Genovese et al. 2020 |
Placebo (n=212; 0%), Upadacitinib 15 mg once daily (n=211; 0%), Upadacitinib 30 mg once daily (n=218; 0%) |
16 | 6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints |
| PSUMMIT 1 McInnes et al. 2013 |
Placebo (n=206; 100%), Ustekinumab 45 mg (n=205; 100%), Ustekinumab 90 mg (n=204; 100%) |
16 | ≥6 months diagnosis; ≥5 swollen joints and ≥5 tender joints; high-sensitivity CRP level of ≥3.0 mg/dL and active or documented history of plaque PsO |
| PSUMMIT 2 Ritchlin et al. 2014 |
Placebo (n=104; 40,4%), Ustekinumab 45 mg (n=103; 41,7%), Ustekinumab 90 mg (n=105; 44,8%) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥5 swollen joints and ≥5 tender joints; high sensitivity CRP level of ≥6.0 mg/dL |
| BE-ACTIVE Ritchlin et al. 2020 |
Placebo (n=41; NR), Bimekizumab 16 mg every four weeks (n=41; NR), Bimekizumab 160mg every four weeks (n=41; NR), Bimekizumab 160mg every four weeks + (LD 320mg) (n=41; NR), Bimekizumab 320mg every four weeks (n=41; NR) |
12 | CASPAR criteria; ≥3 swollen joints and ≥3 tender joints; Active psoriatic lesion or documented history of psoriasis; tested negative for rheumatoid factor and anti-cyclic citrullinated peptide antibodies. |
| NCT02719171 Mease et al. 2022 |
Placebo (n=42; 76,2%), Risankizumab 150mg every four weeks (n=42; 73,8%), Risankizumab 150mg on weeks 0, 4, and 16 (n=39; 76,9%), Risankizumab 150mg on weeks 0 and 12 (n=20; 80%), Risankizumab 75 mg on week 0 (n=42; 73,8%) |
16 | CASPAR criteria;≥5 tender joints and ≥5 swollen joints;≥1 psoriatic lesion or documented history of psoriasis |
| BE COMPLETE Merola et al. 2023 |
Placebo (n=133; 53%), Bimekizumab 160 mg every four weeks (n=267; 48%) |
16 | ≥6 months diagnosis; CASPAR criteria; ≥3 swollen joints and ≥3 tender joints. ≥1 active psoriatic lesion or a documented history of psoriasis or both. |
| KEEPsAKE 2 Ostor et al. 2022 |
Placebo (n=219; 53,9%), Risankizumab 150mg on weeks 0, 4, and 16 (n=224; 53,1%) |
24 | CASPAR criteria;≥5 tender joints and ≥5 swollen joints; active plaque psoriasis with ≥1 psoriatic plaque of ≥2 cm in diameter or nail changes consistent with psoriasis at screening. |
| KEEPsAKE 1 Kristensen et al. 2022 |
Placebo (n=481; 89,8%), Risankizumab 150mg on weeks 0, 4, and 16 (n=483; 89,2%) |
24 | ≥6 months CASPAR criteria, ≥5 tender and ≥5 swollen joints, ≥1 erosion based on centrally read radiograph (hands and/or feet) or high-sensitivity C reactive protein (hsCRP) ≥3.0mg/L and active plaque psoriasis (≥1 psoriatic plaque(s) of ≥2cm in diameter or nail psoriasis). |
| BE OPTIMAL McInnes et al. 2023 |
Placebo (n=281; 32%), Bimekizumab 160mg every four weeks (n=431; 30%), Adalimumab 40mg every two weeks (n= 140; 29%) |
16 | ≥6 months CASPAR criteria, ≥3 tender and ≥3 swollen joints, ≥1 active psoriatic lesion or a documented history of psoriasis or both. |
| Mease et al. 2000 | Etanercept 25mg twice a week (n=30; NR), Placebo (n=30; NR) |
12 | active psoriatic arthritis; ≥3 swollen joints and ≥3 tender or painful joints |
NR=not reported
The costs of the medicines are from drug database available at Terveysportti health portal (Duodecim Publishing Company Ltd) «https://www.terveysportti.fi/»1. We use retail prices based on the cheapest product price per dose of the medical substance in question. All package sizes are included in the comparison to find the cheapest dose. If a biosimilar is available, it is presented as a separate product alongside the original product.
The calculations are presented for two different time periods, one to present the cost for maintenance dose (28-day period) and another to present the cost for reaching the effectiveness target ACR50 (16-week period which was the most common length of follow-up period in the RCT studies). We calculated the cost per period based on cost per dose, and the number of doses needed. The dosing schedule does not always match with the 16-week or the 28-day period. In these cases, we use the costs that cover only the length of the period (i.e. we use decimals of doses).
Costs of the 16-week treatment response include the loading doses at the start of the new medication. For s.c. infliximab, the 16-week cost consists of only the maintenance dose, since data of i.v. loading dose cost was not available. The 28-day cost includes only maintenance dose costs. Any other direct or indirect costs or reimbursements are not considered.
For medications with dosing based on the weight of patient, we used 70 kilograms to calculate the cost for the medication.