Real-world outcomes following switching from anti-TNF reference products to biosimilars for the treatment of psoriasis

Figures & data

Table 1. FDA-approved biosimilars for psoriasis.

Reference product	Biosimilar	Suffix	Proprietary name
Adalimumab (Humira)	ABP 501	-atto	Amjevita
	BI 695501	-abdm	Cyltezo
	SB5	-bwwd	Hadlima
	GP2017	-adaz	Hyrimoz
	PF-06410293	-afzb	Abrilada
	FKB327	-fkjp	Hulio
	CHS-1420	-aqvh	Yusimry
Etanercept (Enbrel)	GP2015	-szzs	Erelzi
	SB4	-ykro	Eticovo
Infliximab (Remicade)	CT-P13	-dyyb	Inflectra
	SB2	-abda	Renflexis
	GP1111	-qbtx	Ixifi
	ABP 710	-axxq	Avsola

Table 2. Published real-world studies on switching to approved anti-TNF biosimilars for the treatment of psoriasis.

Adalimumab RP
Study	Switch	Design	N patients	Follow-up	Effectiveness	Safety	Conclusions
Nielsen et al. (13)	Adalimumab to GP2017	Retrospective, single center, single arm	43	NR	The overall mean score in PASI and DLQI increased with 0.21 points (CI: −0.32 to 0.76; p = .42) and 1.09 points (CI: −0.46 to 2.63; p = .16).	The fraction of patients with AEs increased from 0% to 39.5% after switching, most commonly pruritus, flares and headache.	Switch was not associated with a change in PsO disease severity or quality of life, but did show increased rate of AEs.
Giunta et al. (14)	Adalimumab to ABP 501	Retrospective, single center, single switch	46 patients switched from originator 48 adalimumab- naïve patients	6 months	No difference in mean PASI or DAS28 seen following switch. Mean PASI improved from 10.66 at baseline to 1.80 at 6 months (p < .0001) and mean DAS28 improved from 3.95 to 2.5 (p > 0.05) in adalimumab-naïve patients.	No AEs after switch. Five adalimumab-naïve patients experienced mild AEs (4 injection-site reactions, 1 upper respiratory tract injection).	No loss of effectiveness or increase in safety concerns following switch for treatment of PsO or PsA. Treatment with ABP 501 in originator-naïve patients is effective and safe.
Gallo et al. (15)	Adalimumab to unnamed biosimilar	Prospective, single center, single switch	73	6 months	No difference in PASI or VAS between time of switch and 3- or 6-month follow up (p > .05). VAS at 3 months from the switch was higher compared to the switch in subgroup of patients with BMI > 25 (p = .04) without change in PASI.	9.6% of patients experienced mild AEs after switch (recurrent candida cheilitis, asthmatic-like symptoms, asthenia after injection, gastrointestinal symptoms, injection site reaction).	Switch was not associated with a change in effectiveness or safety but with trend toward increased AEs.
Di Cesare et al. (16)	Adalimumab to SB5	Single center, single switch	20	6 months	No relevant change in PASI score in 90% of patients; two patients demonstrated loss of effect LOE for cutaneous symptoms. Among the five patients with axial PsA, there was an increase in BADSI score from 1.1 ± 1.23 (0–2.9) to 3.66 ± 3.68 (0–7.6) after switch.	No safety issues were addressed.	Switch to B5 is well tolerated, safe and effective in the treatment of PsO and PsA although with trend toward progressive loss of response in patients with axial disease.
Loft et al. (17)	Adalimumab to GP2017 or SB5	Prospective, DERMBIO registry, single switch with comparator cohort of patients continued on originator	348 patients switched from originator 378 patients continued on adalimumab	12 mo	One-year drug retention rates were 92.0% (95% CI, 89.0–94.9%) for the adalimumab biosimilar cohort and 92.1% (95% CI, 89.4–94.8%) for the adalimumab originator cohort. Mean change in PASI and DLQI after switch was 0.0 (−0.3 to 0.2; p = .63) and 0.0 (−1.0 to 0.0; p = .75).	More AEs were seen in the biosimilar cohort compared to originator cohort (9.1% vs 5.0%, p = .04), the most common being infection.	Similar effectiveness between cohorts, but with increased rate of AEs after switch.
Etanercept RP
Pescitelli et al. (18)	Etanercept to SB4	Retrospective, single center, single switch	32	6 months	Clinical remission (defined as both PASI and/or DAS28 increase < 10%) of 92% and 64% for PsO and PsA respectively in patients after switch. No significant differences in DAS28 after switch, whereas PASI improved significantly (p < .001).	No serious AEs; injection site-reaction to SB4 was observed in four patients after switch.	No change in effectiveness for treatment of cutaneous symptoms or AEs after switch, but with mild decrease in effectiveness for treatment of articular symptoms.
Lund et al. (19)	Etanercept to SB4	Retrospective, single center, single switch	24	NR	52.4% of PASI and 69.2% DLQI scores were the same or improved after switch. The rate of congruence between the self-reported measured change was 69.2%.	The fraction of patients with AEs increased after switch from 0% to 16.7% (fatigue, gastrointestinal complaints and pruritus).	40% of patients reported a worse effect after switch, although the absolute mean change in PASI score was small and not different among patients who reported the same/better effect compared to those reporting a worse effect.
Giunta et al. (20)	Etanercept to SB4	Retrospective, single center, single switch with comparator cohort of etanercept-naïve patients	10 patients switched from originator 30 etanercept-naïve patients	6 months	PASI scores improved from 6.45 to 1.22 (p < .001) and DAS28 score improved from 5.45 to 3.27 (p < .001). No change in PASI or DAS28 between patients switched from etanercept to SB4 and etanercept naïve patients.	No serious AEs were observed or reported.	No change in effectiveness or AEs in patients switched compared to originator-naïve patients on biosimilar.
Egeberg et al. (21)	Etanercept to SB4	Prospective, DERMBIO registry, single switch with comparator cohort of patients continued on originator	55 patients switched from originator 566 patients continued on etanercept	6 months	No difference in treatment discontinuation between patients who continued etanercept and those who switched from etanercept to SB4 (crude HR 0.46, 95% CI: 0.11–1.98; p = .3).	Incidence of AEs was not higher for biosimilars than originators.	Switch had no impact on drug survival or increased AEs.
Gisondi et al. (22)	Etanercept to SB4	Psobiosimilars Registry, single switch with comparator cohort of etanercept-naïve patients	158 patients switched from originator 39 etanercept-naïve patients	6 months	Mean PASI was unchanged in the switch group from 3.1 ± 3.3 at baseline to 1.8 ± 1.9 at month 6 (p > .05). Mean PASI was reduced in the naïve group from 12.5 ± 6.2 at baseline to 6.7 ± 2.2 at month 6 (p = .03).	No difference in AEs between switch and naïve groups.	Patients with chronic plaque psoriasis who responded to etanercept and switched to SB4 did not experience a meaningful change in effectiveness or safety.
Piaserico et al. (23)	Etanercept to SB4 to GP2015	Prospective, multi-center, cross switch	76	12 months	Median PASI remained stable, from 1 (0–2) after 3 months to 0.5 (0–1) after 12 months.	No treatment emergent serious AEs were reported. After the cross-switch from SB4 to GP2015, two patients developed a flare-up of symptoms.	Switching between two etanercept biosimilars (from SB4 to GP2015) is both safe and effective.
Infliximab RP
Lund et al. (19)	Infliximab to CT-P13	Retrospective, single center, single switch	45	NR	74.4% of PASI and 69.0% DLQI score were the same or improved after switch. The rate of congruence between the self-reported measured change was 66.7%.	The fraction of patients with AEs increased after switch 6.7% to 22.2% (fatigue, gastrointestinal complaints and pruritus).	25% of patients reported a worse effect after switch, although the absolute mean change in PASI score was small and not different among patients who reported the same/better effect compared to those reporting a worse effect.
Dapavo et al. (24)	Infliximab to CT-P13	Prospective, single center, single switch with comparator cohort of infliximab-naïve patients	30 patients switched from originator 5 infliximab- naïve patients	33 weeks	PASI and VAS scores were not different after switch (p > .05). 4/5 infliximab-naïve achieved 75% improvement or better from baseline PASI to week 10.	No additional AEs reported after switch.	Patients with psoriasis and a long-lasting response to the infliximab originator can be switched to the infliximab biosimilar without experiencing a significant change in clinical response or additional AEs.
Ricceri et al. (25)	Infliximab to CT-P13	Prospective, single center, single switch	22	10 months	Rates of clinical remission (defined as both PASI and/or Ritchie index not increasing by > 10%) of 86% and 77% for patients with PsO and PsA, respectively.	No change in AEs after switch.	Switching from the originator to biosimilar in patients with PsO has similar safety and effectiveness for control of cutaneous symptoms but with mild decrease in effectiveness for control of articular symptoms.
Egeberg et al. (21)	Infliximab to CT-P13	Prospective, DERMBIO registry, single switch with comparator cohort of patients continued on originator	90 patients switched to CT-P13 266 patients continued on infliximab	24 months	No difference in treatment discontinuation between patients who continued infliximab and those who switched from infliximab to CT-P13 (crude HR 1.64, 95% CI: 0.69–3.89; p = .3).	Incidence of AEs was not higher for biosimilars than originators.	Switching from originator to biosimilar infliximab had no impact on drug survival.
Gisondi et al. (26)	Infliximab to CT-P13	Psobiosimilars registry, single switch with comparator cohort of infliximab-naïve patients	122 patients switched from originator 82 Infliximab-naïve patients	6 mo	PASI score remained unchanged in the switch group (2.05 ± 2.8 vs. 2.2 ± 3.2; p = .3). PASI score was reduced in the naïve group from baseline 20.8 ± 12.1 to 6-month 7.2 ± 7.1 (p = .001).	No difference in number of AEs between switch and naïve groups.	Patients with chronic plaque PsO who respond to the infliximab originator can be switched to the biosimilar CT-P13 without experiencing a significant change in clinical response or additional AEs.
Gisondi et al. (27)	CT-P13 to SB2	Prospective, single center, single switch	96	6 months	PASI remained stable at time of switch to 2, 4, and 6 month follow ups (0.9 ± 2; 0.9 ± 1.6; 1.1 ± 2.2; 0.7 ± 1.1).	Acute infusion reactions (n = 3), upper respiratory infections (n = 6) and herpes zoster infection (n = 1) were reported.	The switch from CT-P13 to SB2 was not associated with a change in disease severity although did show treatment withdrawal 10% of patients because of loss of response (n = 7) or acute infusion reactions (n = 3).

PsO: psoriasis; PsA: psoriatic arthritis; AEs: adverse events; LOE: loss of effect; BMI: body mass index; PASI: Psoriasis Area and Severity Index; DLQI: Dermatology Life Quality Index; VAS: Visual Analog pain Scale for joint pain; BADSI: Bath Ankylosing Spondylitis Disease Activity Index; DAS28: Disease Activity Score in 28 joints.

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