Recruitment open to Spevigo (spesolimab)

We are now accepting patients on Spevigo (spesolimab). Spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (GPP). BADBIR can accept registrations for patients with a GPP diagnosis.

Please see the eligibility page for full details of the treatments we currently recruit for.

Recruitment re-open to Stelara, Humira, Amgevita, Hulio, Hyrimoz, Idacio, Yuflyma

BADBIR is now open to registrations of patients commencing on the following drugs:

• Stelara (ustekinumab)
• Humira (adalimumab)
• Amgevita (adalimumab)
• Hulio (adalimumab)
• Hyrimoz (adalimumab)
• Idacio (adalimumab)
• Yuflyma (adalimumab)

If a patient is already registered on BADBIR in the conventional or small molecule cohort and has started one of these treatments, we can now resume follow-up on these patients by switching them to the biologic cohort if they started treatment after 01/01/2019. We will leave data queries on any eligible patients over the next few months confirming this before carrying out the cohort switches.

In the meantime, you can leave feedback on your patients if they fall under this scenario, and we can switch them sooner.

Please see the eligibility page for full details of the treatments we currently recruit for.

Password policy updates to the BADBIR Database

In our ongoing commitment to maintaining a secure and user-friendly online environment, we are updating our password policy. We kindly request all our users to consider reviewing and enhancing the strength of their passwords in preparation for the new criteria, which will take effect on December 1st, 2023.

Your new password must contain:

• A minumum of 14 characters
• At least 1 number
• At least 1 special character (such as @ _ ! $ ^ %)

To change your password, log into the database and then go to the Manage Account area from the top-right corner of the page. The link to change your password is located here.

Please note that if your existing password already fulfils the new criteria, there is no requirement to change it.

If you do not change your password to meet the new criteria by December 1st, 2023, a forced password reset will occur. Users will be prompted to reset their passwords upon their next login attempt. This process will require them to create a new password that complies with the updated policy.

This update is designed to further strengthen your account's security while ensuring a smooth transition for all users, and be in line with password policy at the University of Manchester. We appreciate your cooperation and are here to support you in any way we can. If you have any questions or need assistance with password updates, our team is available at badbir@manchester.ac.uk.

Please be aware that we will not send you any direct communication about this password change, such as individual emails asking you to click a link to change your password. We will only notify you of this change as a part of our monthly centre report which you should be receiving routinely.

Recruitment to Kyntheum, Cimzia and Skilarence ending; Sotyktu registrations now accepted

Recruitment to Kyntheum (brodalumab), Cimzia (certolizumab pegol), and Skilarence (dimethyl fumarate) has now ended. Patients who were consented and started these treatments before the 1^st August must be added to the database before 21^st August. Recruitment is temporarily paused on Ilumetri (tildrakizumab) from 1^st August and we will provide an update as soon as possible.

BADBIR is now open to registrations of patients commencing on the small molecule drug Sotyktu (deucravacitinib). Patients can be recruited even if they're biologic-exposed.

Please see the eligibility page for full details of the treatments we currently recruit for.

BADBIR Team at the BDNG 31^st Annual Conference

The BADBIR team will be present in Harrogate for the BDNG Annual Conference 20^th - 22^nd September.

We hope to see you there!

BADBIR Team at the July 2022 BAD Annual Meeting

The BADBIR team will be present in Glasgow for the 2022 BAD Annual Meeting 5^th - 7^th July.

We will have a stand in the exhibition hall plus presentations in the morning Medical Dermatology session (Effect modification of biologic survival by patient characteristics) and at a Hot Topics session in the afternoon break on Wednesday 6th July.

We hope to see you there!

Bimzelx (bimekizumab) registrations now accepted

We are pleased to announce that registrations to BADBIR can now be accepted for patients commencing on Bimzelx (bimekizumab).

As with all new registrations, BADBIR inclusion criteria apply, meaning patients are eligible to join the Register if they sign consent within six months of commencing Bimzelx (bimekizumab) for treatment of psoriasis.

Existing BADBIR participants switching to Bimzelx (bimekizumab) can be followed up as usual. Please see our Eligibility Page for full details.

The Patient Portal is now Live!

We are inviting all centres to begin using the Patient Portal, after a successful pilot phase. There is no additional set up required from centres to use the Portal. Please read through the Portal information page for the full details.

We are currently offering training sessions on the Patient Portal for anyone who would like to attend. You can register your interest in these sessions by following the link below, and we will contact you once dates and times are finalised:

Register interest for Patient Portal training session

Non-substantial amendment relating to the upcoming Patient Portal

The pilot of the Patient Portal has progressed well and we are on schedule to open to all sites from 1^st September. In advance of this date, a non-substantial amendment has been approved to recognise contacting participants with details of the Portal is part of study procedure (i.e. outside of routine dermatology clinic attendance). No action is required for this amendment, it has already been added to your electronic site file.

You can also view the amendment and acknowledgement on the Site file documents page, under Section 3: Regulatory and other essential documents.

Recruitment to Imraldi (adalimumab biosimilar) and Benepali (etanercept biosimilar) has ended

Please be aware that BADBIR cannot accept any new registrations at baseline for patients starting Imraldi (adalimumab biosimilar) or Benepali (etanercept biosimilar) after 31^st July. Participants must have started treatment and provided consent before 1^st August to be accepted. If participants signed consent and commenced either drug before this date, please ensure baseline data entry is complete on the database by Friday, 20^th August.

This affects new registrations only. Patients already within the biologic cohort switching to Imraldi or Benepali can be followed-up for BADBIR as normal.

Please visit the BADBIR Eligibility Page for details of currently accepted registration drugs.

Database connection issues

The connection issues have now been resolved - you can log into the database here.

Study Amendment 12 Approved

We have recently had notification that the latest study amendment for BADBIR has been approved by ethics and the HRA on 31/08/2018. This is the 12th Substantial Amendment for the BADBIR study.

All UK centre R&D departments were informed 01/09/2020. The implementation date of the amendment will be 35 days later on Tuesday 6th October.

The amendment contains small changes to the Consent Materials. The protocol now allows for collection of questionnaires directly from patients with many dermatology clinics now operation remotely (more information to follow later this year). For full details, all amendment documentation can be found by following this link.

If you have any questions regarding this amendment please don't hesitate to contact us via email or on 0161 306 1896.

Recruitment to Amgevita (adalimumab biosimilar) will end 1^st October

Please be aware that BADBIR will not accept any new registrations at baseline for patients starting Amgevita (adalimumab biosimilar) after 30^th September. Participants must have started Amgevita and provided consent before 1^st October to be accepted.

This affects new registrations only. Patients already within the biologic cohort switching to Amgevita can be followed-up for BADBIR as normal.

Please visit the BADBIR Eligibility Page for details of currently accepted registration drugs.

Update from BADBIR (COVID-19)

Dear Researchers

We have received a number of enquiries from participating BADBIR centres on our plans during this difficult period. This news item aims to answer the key questions on the Register, however if you have any queries not addressed here please contact the BADBIR team directly.

Recruitment status

Recruitment continues as normal and BADBIR remains fully open.

Remote clinic appointments

We understand many dermatology clinic appointments are being conducted remotely only (i.e. phone or video).

To help BADBIR capture this, we now ask at follow-up for confirmation on whether the appointment took place in person or remotely. Where remote clinic appointments have occurred, BADBIR follow-ups will still be paid for even where no PASI is recorded.

As an observational study, we will collect what information is taken when the patients are assessed regardless of whether this is an in-person clinic visit or one done remotely.

We ask that particular attention is paid to recording accurate information on drug exposure and adverse events.

Contacting the BADBIR team

We recommend using the BADBIR database to communicate directly with any information relating to individual participants. At present the office team are working remotely. To contact the BADBIR over the phone, please use the temporary number of 07557 545199.

COVID-19 adverse events

For suspected cases, please record as much information as possible on the symptoms and duration of illness during Adverse Event data entry. For confirmed cases which result in hospitalisation, we ask a Serious Infection ESI Form be completed. If in any doubt please contact the BADBIR team on via email badbir@manchester.ac.uk and we can provide further advice. We will also update the BADBIR website and database with further information on best practice data collection as required.

With best wishes

BADBIR

Conducting a BADBIR follow-up remotely

We understand many dermatology clinic appointments are being conducted remotely only (i.e. phone or video).

To help BADBIR capture this, we now ask at follow-up for confirmation on whether the appointment took place in person or remotely. Please choose an option from the drop-down menu, which you will find on the first page of the follow-up.

Where remote clinic appointments have occurred, BADBIR follow-ups will still be paid for even where no PASI is recorded. As an observational study, we will collect what information is taken when the patients are assessed regardless of whether this is an in-person clinic visit or one done remotely.

We ask that particular attention is paid to recording accurate information on drug exposure and adverse events.

Temporary BADBIR Office Contact Details

The BADBIR team based at the University of Manchester is following the national guidance surrounding the spread of COVID-19. The team is now working remotely until further notice.

BADBIR remains open for all recruitment and follow-up activities. The team will remain on hand to offer support. All database and email contact remains unchanged. Please note telephone advice:

• 07557 545199 is the only phone number available to contact the BADBIR team directly. This will be manned during office hours Monday to Friday. If you would like to arrange a call back, please email badbir@manchester.ac.uk

Skyrizi (risankizumab) registrations now accepted

We are pleased to announce that registrations to BADBIR can now be accepted for patients commencing on Skyrizi (risankizumab).

As with all new registrations, BADBIR inclusion criteria apply, meaning patients are eligible to join the Register if they sign consent within six months of commencing Skyrizi (risankizumab) for treatment of psoriasis.

Existing BADBIR participants switching to Skyrizi (risankizumab) can be followed up as usual. Please see our Eligibility Page for full details.

As a reminder, baseline registrations are currently accepted for the following treatments:

Dose suggestion system for Stelara and Infliximab Biosimilars

We have developed a system to suggest and automatically generate doses for the biologic therapies we enter with a frequency of "N/A". This can be found on the biologic therapy edit page.

First, you will be asked whether you know the dates of each individual dose during the follow-up period. If you choose "Yes" here, you can enter the dates, doses and batch numbers as normal. Choosing "No" here will present the next question.

If you choose "No" for the question above, you will be asked if, to the best of your knowledge, the patient deviated from the dose schedule. If the patient did not follow the normal schedule, choose "The patient deviated", and enter details in the text box that appears.

However, if you choose "The patient followed the schedule", you will be presented with the new dose suggestion system. It will scan through all of the existing doses in the drug record, suggest new doses to enter that fit the schedule of the drug, and show you a report on the doses already entered (see the key at the top).

The report will highlight doses that may be too early or too late, which will help you determine whether the patient deviated from the normal schedule. If you are happy with the doses highlighted in green being added for you, click "Add suggested doses". You can delete one or more of them afterwards if necessary.

You can restart these dose questions at any time, by clicking the "Restart the dose questions" button at the top of the section. You may find this system useful to check whether the existing doses match the expected schedule for that drug, even if you don't use it to enter them automatically.

Ilumetri (tildrakizumab) registrations now accepted

We are pleased to announce that registrations to BADBIR can now be accepted for patients commencing on Ilumetri (tildrakizumab). As with all new registrations, BADBIR inclusion criteria apply; meaning patients are eligible to join the Register if they sign consent within six months of commencing Ilumetri (tildrakizumab) for treatment of psoriasis.

Existing BADBIR participants switching to Ilumetri (tildrakizumab) can be followed up as usual. Please see our eligibility page for full details.

For further information, please contact the BADBIR office.

Important updates to BADBIR with effect from 1^st August 2019

End of recruitment to Humira and Stelara

BADBIR no londer accepts new baseline registrations of patients commencing Humura (adalimumab) or Stelara (ustekinumab). All patients must be consented and have started treatment on 31^st July or earlier to be included on the Register.

Pause to Otezla recruitment

There is a pause to recruitment for Otezla (apremilast) with effect from 1^st August 2019. We will provide further updates as soon as possible. Please do not enter any registrations onto the database where a patient has commenced Otezla or consented after 31^st July 2019.

For further information, please contact the BADBIR office.

Important Updates from BADBIR - June 2019

Please note two important updates for the BADBIR study. These are also summarised in the Summer 2019 newsletter:

End of Recruitment to Humira and Stelara

With effect from 01/08/2019, BADBIR will no longer be able to accept new baseline registrations of patients commencing Humira (adalimumab) or Stelara (ustekinumab). All patients consented after 31st July will not be able to join the Register.

For patients already registered in the biologic cohort, follow-up can continue to be entered as normal for any changes to Humira or Stelara.

HADS Questionnaire

With effect from 17/06/2019, we will request that all patients complete the HADS questionnaire from baseline to follow-up 6. This questionnaire was approved for use last year in study amendment 11 and we have now received final permission from the licence holder to use HADS.

The data entry pages are open to collect the questionnaire. In the event of the HADS being missed, please remember to record 'No' to the 'Was a HADS Questionnaire completed?' question to avoid data queries.

Scores for both anxiety and depression will be automatically calculated on entry by the BADBIR database system, with high scores highlighted. Please see the link in the HADS section to some exemplar text that may be used/modified at your discretion to inform the patient's GP (or other appropriate health care professional) as per your usual clinical practice.

Adverse events data entry changes

We have changed the way we collect adverse event descriptions on the BADBIR database. In order to obtain a more accurate picture of the event, we have split the description into three separate boxes:

Symptoms, Diagnosis and Treatment. If some of these details aren't available, please state this in the corresponding text box.

The purpose of this change is to make the data entry more efficient, and reduce the number of pharmocovigilance queries that are raised on adverse events.

The short description box will remain visible for a short period, but disabled for data entry.

An amended follow-up questionnaire is now on the website. If you have any questions regarding this change, please contact the office on 0161 306 1896.

Imraldi (Adalimumab biosimilar) registrations now accepted

Registrations to BADBIR can now be accepted on patients commencing on Imraldi (Adalimumab biosimilar).

As with all new registrations, BADBIR inclusion criteria apply meaning patients are eligible to join the Register if they sign consent within six months of commencing Imraldi (Adalimumab biosimilar) for treatment of psoriasis.

Existing BADBIR participants switching to Imraldi (Adalimumab biosimilar) can be followed up as usual. Please see our Eligibility Page for a reminder on the full list of treatments the study is accepting registrations for.

BADBIR office move

The BADBIR team are moving offices in the week of Monday 29^th April. Please be aware there may be a short delay in responding to queries and emails during this week.

Details of the new postal address for BADBIR will be updated on the website, but most of the phone numbers will remain the same. Please check the Contact page for more details.

BADBIR will no longer be receiving faxes from May 1^st

With effect from May 1^st 2019, BADBIR will no longer accept consent forms or other documentation sent by fax. The recommended method to send a consent form to us for a newly registered patient is to upload it directly to the database while data entry is completed.

For further advice please check the BADBIR website, or contact the office directly.

Members to join the BADBIR Steering Committee

The British Association of Dermatologists (BAD) is looking for enthusiastic individuals to become members of the BAD Biologics and Immunomodulators Register (BADBIR) Steering Committee.

BADBIR is a UK and Eire observational study seeking to assess the long-term safety of biologic treatments for psoriasis. The Steering committee is responsible for the overall objectives of the study as well communicating to the BAD members and to patient care and representative organisations.

There are three meetings held each year (one in London and two in Manchester) and it is expected all members attend a minimum of two meetings. The term of appointment is for three years.

BADBIR will cover your travel expenses and provide lunch. If you would like to apply or would like to find out more, please contact Sagair Hussain (BAD Biologics Manager) - sagair@bad.org.uk.

The closing date for applications is: 30^th April 2019

The next BADBIR Steering Committee meeting will be held on Wednesday 5^th June.

Amgevita, Hyrimoz, Tremfya & Zessly registrations now accepted

Registrations to BADBIR can now be accepted on patients commencing on the following treatments:

• Amgevita (Adalimumab Biosimilar)
• Hyrimoz (Adalimumab Biosimilar)
• Tremfya (Guselkumab)
• Zessly (Infliximab Biosimilar)

Existing BADBIR participants switching to any of these drugs can be followed up as usual. Please see the Eligibility Page for the full details.

The data entry pages will be updated early in 2019 to accommodate entry of these therapies though new participants can now be consented if starting on these treatments.

Kyntheum (brodalumab) registrations now accepted

BADBIR is accepting Biologic Cohort registrations for patients commencing on Kyntheum (brodalumab).

As with all new registrations, BADBIR inclusion criteria apply meaning patients are eligible to join the Register if they sign consent within six months of commencing Kyntheum (brodalumab) for treatment of psoriasis.

Existing BADBIR participants switching to Kyntheum (brodalumab) can be followed up as usual.

Please see our Eligibility Page for a reminder on the full list of treatments the study is accepting registrations for.

Cimzia (certolizumab pegol) recruitment is starting

We can now confirm that BADBIR is accepting registrations for patients commencing on Cimzia (certolizumab pegol).

BADBIR inclusion criteria apply, which means patients are eligible to join the Register if they sign consent within six months of commencing Cimzia (certolizumab pegol) for treatment of psoriasis.

Any current BADBIR patients switching to Cimzia (certolizumab pegol) can be followed up as usual.

Please see our Eligibility Page for full details of all the treatments we currently recruit for.

Skilarence (dimethyl fumarate) recruitment is starting

We can now confirm that BADBIR is able to accept new registrations of patients commencing on Skilarence (dimethyl fumarate). This treatment is within the new non-biologic small molecule immunomodulator cohort on BADBIR.

Patients in the small molecule cohort should be naive to biologic therapy and sign consent within six months of commencing the registration treatment. Full eligibility criteria are on the BADBIR website.

Final changes are now being made to the database to allow entry of Small Molecule Immunomodulator cohort patients. At present, patients commencing Skilarence (dimethyl fumarate) may be consented now and entered on the database later once the development work is complete. If any currently registered BADBIR patients are commencing on Skilarence (dimethyl fumarate), please contact the BADBIR office for further advice (badbir@manchester.ac.uk / 0161 306 1896)

Supported Browsers for the BADBIR Database

As part of ongoing development on the BADBIR database, after 31st January 2018 we will be unable to support older web browsers. The database will be inaccessible to older browsers after this date.

The BADBIR database will support the following web browsers:

• Google Chrome version 48 or later (released in Jan 2015)
• Microsoft Internet explorer version 11 (released in Oct 2013)
• Microsoft Edge (any version)
• Mozilla Firefox version 38 or later (released in Jan 2015)
• Apple Safari version 8 or later (released in Oct 2014)

If you are unsure on what browser you are using and whether you need to take action, please consult your IT support. A simple way to check if your browser is unsupported will be to visit the database log-in page. If you see a message box advising you to update, this means you have an older browser. If there is no message onscreen, no action is required.

Further reminders will be provider closer to the deadline date. In the meantime please contact the BADBIR office with any queries (badbir@manchester.ac.uk / 0161 306 1896).

Otezla (apremilast) recruitment is starting

We can now confirm that BADBIR is able to accept new registrations of patients commencing on Otezla (apremilast). This treatment is within the new non-biologic small molecule immunomodulator cohort on BADBIR.

Patients in the small molecule cohort should be naive to biologic therapy and sign consent within six months of commencing the registration treatment. Full eligibility criteria are on the BADBIR website.

Changes to the database are currently being made to allow entry of these patients. At present, patients commencing Otezla (apremilast) may be consented now and entered on the database later once the development work is complete. If any currently registered BADBIR patients are commencing on Otezla (apremilast), please contact the BADBIR office for further advice (badbir@manchester.ac.uk / 0161 306 1896).

Erelzi (etanercept biosimilar) recruitment is starting

We can now confirm that BADBIR is able to accept new registrations of patients commencing on Erelzi (etanercept biosimilar). BADBIR inclusion criteria apply which means patients are eligible to join the Register if they sign consent within six months of commencing Erelzi (etanercept biosimilar).

Any current BADBIR patients switching to Erelzi (etanercept biosimilar) can be followed up as usual.

BADBIR Electronic Delegation Log is now live

The Delegation Log for each BADBIR centre has changed. Previously, this was a paper document stored in the local site file. As an improvement measure for study governance, the log is now stored electronically within the BADBIR database.

Please can all users follow the link to the Electronic Delegation Log once logged in to the database, and review all of the entries for accuracy. Please pay particular attention to the following:

• End dates for any staff no longer working on BADBIR
• Whether the names of all current researchers at your centre are included
• Spelling of the names on the delegation log

The process for new users applying for access to BADBIR has also changed. Please see the updated guidance on the database registration page for more information.

Please contact the office on 0161 306 1896 or badbir@manchester.ac.uk if any further information is required.

Taltz (Ixekizumab) recruitment is starting

We can now confirm that BADBIR is able to accept new registrations of patients commencing on Taltz (Ixekizumab). BADBIR inclusion criteria apply which means patients are eligible to join the Register if they sign consent within six months of commencing Taltz (Ixekizumab).

Any current BADBIR patients switching to Taltz (Ixekizumab) can be followed up as usual.

Enbrel (Etanercept) recruitment has ended

BADBIR has finished recruitment for patients commencing Enbrel as of 31^st July 2016. Any patients who consent and/or start Enbrel after this date will not be eligible for entry onto BADBIR.

All BADBIR patients currently on Enbrel or switching to Enbrel at follow-up will continue to be followed up as per the BADBIR protocol. Recruitment continues to all other cohorts as usual.

Thanks to everyone for contributing to the recruitment of this cohort.

Benepali (Etanercept biosimilar) recruitment is starting

BADBIR is now accepting all new registrations receiving Benepali and switches to this drug at follow-ups. All other eligibility criteria still apply.

Enbrel (Etanercept) recruitment is coming to an end on 31/07/2016

Please be aware that recruitment of patients commencing on Enbrel will end after 31/07/2016. All patients who consent and/or start Enbrel after this date will not be eligible for entry on to BADBIR.

All BADBIR patients currently on Enbrel or on another biologic drug and switch to Enbrel will continue to be followed up as per the BADBIR protocol. Recruitment continues to all the other cohorts as usual.

Thanks to everyone for contributing to the recruitment of this cohort.

Addition of biosimilars to biologic list at follow-up

With the first wave of biosimilars now on the market, BADBIR has added Inflectra (Infliximab) and Remsima (Infliximab) to the biologic drug list at follow-up. These are distinct treatments to the originator drug (Remicade) therefore it is important that BADBIR is made aware of any changes to treatment during follow-up data entry.

For example, if a patient had been switched from Remicade to Inflectra, a stop date would need to be recorded for the first treatment and a new start date input for the biosimilar.

Please contact the BADBIR office if you require any clarification.

Cosentyx (Secukinumab) recruitment started - message from BADBIR Chief Investigator

Dear BADBIR Investigator,

We can now confirm that BADBIR is able to accept new registrations of patients commencing on Cosentyx. BADBIR inclusion criteria apply which means patients are eligible to join the Register if they sign consent within six months of commencing Cosentyx. Any current BADBIR patients switching to Cosentyx can be followed up as usual.

If you have any questions, please do not hesitate to contact us. Thank you for your continued contribution to BADBIR.

Kind regards,

Chris

Professor Chris Griffiths, BADBIR Chief Investigator

Humira (Adalimumab) recruitment resumed - message from BADBIR Chief Investigator

Dear BADBIR Investigator,

At the end of last year, recruitment to Humira was paused while we applied for ethical approval to increase the cohort size to 5000 patients (BADBIR Protocol Amendment 9). This has been approved and therefore we are now in a position to accept registrations of participants starting on Humira. The process of circulating Amendment 9 to all the R & D departments is underway.

Please do not hesitate to contact the BADBIR office if you have any questions and thank you for your continued contribution to BADBIR.

Kind regards,

Chris

Professor Chris Griffiths, BADBIR Chief Investigator

BADBIR will start using Biologic Drug Trade Names

Effective from Wednesday 14th October 2015, BADBIR database is using the trade name of biologic drugs instead of their originator names. All existing information has been updated. For example, Adalimumab now shows as Humira in the BADBIR database.

See the table below for the drugs affected by this change:

If you have any concerns or are worried about how this can change the way you use the BADBIR database, please feel free to contact us.