Research Highlights Real-World Evidence, Including PROs, With 3 Infliximab Biosimilars

Jackie Syrop

Several posters at the 2017 American College of Rheumatology Annual Meeting in San Diego, California, compared the efficacy of originator and biosimilar infliximab in the treatment of rheumatic diseases.

Several posters at the 2017 American College of Rheumatology Annual Meeting in San Diego, California, compared the efficacy of originator and biosimilar infliximab in the treatment of rheumatic diseases.

Non-medical Switch from Originator to Biosimilar Infliximab in AS

Czech researchers found no consistent trend of change in disease activity measures and patient-reported outcomes (PROs) after a non-medical switch from originator (INX; Remicade) to biosimilar infliximab (CT-P13; Remsima) in patients with ankylosing spondylitis (AS) that would suggest a decrease in efficacy within 6 months of the switch. The mild decrease in patients’ satisfaction that was not correlated with other PROMs may have been caused by a so-called nocebo effect, suggests Sarka Forejtová, MD, and colleagues.1

Thirty-six patients with AS in 1 clinical center were observed for 3 months prior to the switch and 3 months after the switch for measures of disease activity, quality of life, and patient satisfaction with treatment. Prior treatment duration with INX was 86.2±34.7 months.

There were no serious adverse events (SAEs) reported; 1 patient requested a reverse switch to INX.

The researchers acknowledge the limited time frame of their study but say it supports the results of other real-world studies indicating no decrease in efficacy after a non-medical switch from originator to biosimilar infliximab.

CT-P13 Effective, Well-Tolerated in Korean Study of CT-P13 in Routine Care

CT-P13, an infliximab biosimilar, is efficacious and well-tolerated in patients with rheumatoid arthritis (RA), AS, psoriatic arthritis (PsA), and plaque psoriasis (PS) based on the results of a Korean study of CT-P13 by Dong-Wook Kim, MD, and colleagues2 in which it was used in the routine care of 940 patients (RA, 400; AS, 531; PsA, 3; and PS, 6). Of these, 338 (36%) switched to CT-P13 (RA, 108; AS, 228; and PS, 2).

The study included patients who were both biologic-naïve (naïve group) and patients who switched from other anti—tumor necrosis factor (TNF) medications, such as infliximab, adalimumab, golimumab, and etanercept, to CT-P13 (switch group).

Effectiveness was evaluated based on reports of remission and response, and AEs were collected over 6 months.

  • The proportion of patients achieving remission was similar between naïve and switch groups in both RA and AS patients during post-baseline visits.
  • In RA, the proportion of patients achieving each disease activity category by Disease Activity Score-28 (DAS28) was similar between naïve and switch groups.
  • The proportion of patients who achieved a Bath AS Disease Activity Index (BASDAI) 20/50/70 response gradually increased from week 6 to week 24 or 30 in the AS naïve group.
  • 50% of naïve patients in the PsA group achieved remission.
  • In PS, the proportions of both PASI 50 and 75 response were 50% at week 22 in naïve and 100% and 50% in the switch group, respectively, during post-baseline visits.

The researchers concluded that CT-P13 was well tolerated. Only 11% of patients experienced infection. Results from the switch group showed that CT-P13 provides a useful alternative to other anti-TNFs, they note.

SB2 Comparable With Reference Infliximab in Study Using Radiographic Evidence

The proportion of RA patients achieving remission or low disease activity (LDA) was comparable up to week 54 in a study by Josef S. Smolen, MD, and colleagues comparing patients taking INX and biosimilar infliximab, SB2. The study assessed simplified disease activity index (SDAI) and clinical disease activity index (CDAI) and radiographic progression of disease.3

The study assessed SDAI and CDAI at weeks 14, 30, and 54 in 562 patients treated with SB2 or INX and assessed the radiographic disease progression at week 54 in patients by disease activity states (remission, LDA, moderate disease activity [MDA], or high disease activity [HDA]).

Up to week 54, comparable proportions of patients achieved ACR-EULAR—index remission between SB2 and INF. The proportions of radiographic non-progressors by disease activity were comparable between SB2 and INF at week 14, 30, and 54.

Patients treated with SB2 as well as INX also had the lowest progression of radiographic damage in remission and the largest progression in HDA, but also very small increases in measures of radiographic progression of disease in LDA and MDA, in line with previous findings on INF.

Efficacy of PF-06438179/GP1111 Compared With Reference Infliximab in RA

PF-06438179/GP1111, a proposed infliximab biosimilar, and EU-sourced reference infliximab, showed similar efficacy, safety, and immunogenicity in patients with moderate-to-severely active RA after 30 weeks of treatment.4 All the patients in the study were receiving background methotrexate and had not more than 2 doses of 1 non-depleting, non-infliximab biologic.

The trial followed 650 patients stratified by geographic region, who were randomized 1:1 to PF-06438179/GP1111 or infliximab-EU. The study’s primary endpoint was ACR20 response rate at week 13; secondary efficacy endpoints included RA response rates measured by the ACR20, DAS28-C-Reactive Protein (CRP), and other measures of clinical response or remission up to week 30.

  • At week 14, ACR20 response rates in the intent-to-treat population were 62.7% for PF‑06438179/GP1111 and 64.1% for infliximab-EU (treatment difference, -2.39%; CIs were entirely within pre-specified equivalence margins).
  • Response rates through week 30 were similar, with the ACR20 treatment difference ranging from —5.81% to –0.83% at the specified visits. Mean change in DAS28-CRP from baseline was –2.1 at week 30 for both groups.
  • ACR50, ACR70, and EULAR response as well as DAS remission and ACR/EULAR remission were similar between groups at each study visit.
  • Incidences of TEAEs and SAEs were similar between PF‑06438179/GP1111 and infliximab-EU, respectively.
  • Post-dose ADAs through week 30 were 48.6% for PF‑06438179/GP1111 and 51.2% for infliximab-EU.

References

  1. Forejtová S, Zavada J, Szczukova L, Jarosova K, Philipp T, Pavelka K. A non-medical switch from originator infliximab to biosimilar CT-P13 in 36 patients with ankylosing spondylitis: 6-months clinical outcomes from the Czech Biologic Registry ATTRA. Presented at the American College of Rheumatology 2017 meeting, November 7, 2017; San Diego, California. Abstract 1549. acrabstracts.org/abstract/a-non-medical-switch-from-originator-infliximab-to-biosimilar-ct-p13-in-36-patients-with-ankylosing-spondylitis-6-months-clinical-outcomes-from-the-czech-biologic-registry-attra/.
  2. Ki DW, Kim TH, Kwon SR, et al. Effectiveness and safety of CT-P13 in patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis: observational study in Republic of Korea. Presented at the American College of Rheumatology 2017 meeting, November 7, 2017; San Diego, California. Abstract 2444. acrabstracts.org/abstract/effectiveness-and-safety-of-ct-p13-in-patients-with-rheumatoid-arthritis-ankylosing-spondylitis-psoriatic-arthritis-and-plaque-psoriasis-observational-study-in-republic-of-korea/.
  3. Smolen JS, Choe JY, Keystone EC, Rho YH, Lee Y, Lee S. Radiographic progression by disease activity states in patients with rheumatoid arthritis treated with SB2 or reference infliximab. Presented at the American College of Rheumatology 2017 meeting, November 7, 2017; San Diego, California. Abstract 2466. acrabstracts.org/abstract/radiographic-progression-by-disease-activity-states-in-patients-with-rheumatoid-arthritis-treated-with-sb2-or-reference-infliximab/.
  4. Cohen SB, Alten R, Kameda H, et al. A randomized, double-blind study comparing PF-06438179/GP1111, a potential infliximab biosimilar, and infliximab, both in combination with MTX, as treatment for patients with moderate to severe active RA who have had an inadequate response to MTX therapy. Abstract 2798. acrabstracts.org/abstract/a-randomized-double-blind-study-comparing-pf-06438179gp1111-a-potential-infliximab-biosimilar-and-infliximab-both-in-combination-with-mtx-as-treatment-for-patients-with-moderate-to-severe-active/.